Drug Safety Jobs in Bengaluru.
All active Drug Safety roles based in Bengaluru.
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Safety submissions specialist
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Position Summary:
The Safety Submission Specialist, under minimal supervision, will assume the responsibility of reviewing and transmission of required individual cases safety reports (ICSRs) for submission (paper and electronic) to global regulatory agencies, business partners, affiliates and other destinations. Must maintain continuous knowledge and expertise of local and global requirements for safety reporting.
Essential functions of the job include but are not limited to:
- Monitor the Drug Safety Inbox for incoming submission acknowledgements and confirmations of expedited reports
- Maintain various spreadsheets, including but not limited to distribution/submission trackers
- Generate final clinical trial regulatory reports (e.g., CIOMS I, MedWatch 3500A, XML) from the global safety database for distribution/submission
- Prepare and distribute final submission documents, including Investigator Safety Letter
- Perform case closure and electronic filing of SAE related documentation
- Complete expedited report deviations which includes initiation, investigation, extension requests, and CAPAs, as appropriate
- Perform SAE reconciliation and send queries, as appropriate
- Reconcile and send SUSAR Gap Packs
- Maintain and update expedited email distribution lists
- Reconcile compliance metrics
- Support generation of overall distribution/submission compliance metrics
- Monitor regulatory intelligence databases for regulation updates and provides country specific reporting information to support the development of Safety Reporting Plans
- Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate
- Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process
- Attends Department meetings
Qualifications:
Minimum Required:
- Must have sufficient experience and a demonstrated knowledge and understanding of global safety reporting regulations and guidelines including the FDA, ICH, & EU Regulations and Requirements for Pharmacovigilance
- Knowledge of the ARGUS Safety Database
- Minimum 2 years of experience in clinical trial drug safety in the Pharma/CRO industry
- Experience with EMA EudraVigilance, UK MHRA and other recognised reporting portals
- BA/BS preferred
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Ready to apply?
Apply to Precision for Medicine
Safety submissions specialist
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Position Summary:
The Safety Submission Specialist, under minimal supervision, will assume the responsibility of reviewing and transmission of required individual cases safety reports (ICSRs) for submission (paper and electronic) to global regulatory agencies, business partners, affiliates and other destinations. Must maintain continuous knowledge and expertise of local and global requirements for safety reporting.
Essential functions of the job include but are not limited to:
- Monitor the Drug Safety Inbox for incoming submission acknowledgements and confirmations of expedited reports
- Maintain various spreadsheets, including but not limited to distribution/submission trackers
- Generate final clinical trial regulatory reports (e.g., CIOMS I, MedWatch 3500A, XML) from the global safety database for distribution/submission
- Prepare and distribute final submission documents, including Investigator Safety Letter
- Perform case closure and electronic filing of SAE related documentation
- Complete expedited report deviations which includes initiation, investigation, extension requests, and CAPAs, as appropriate
- Perform SAE reconciliation and send queries, as appropriate
- Reconcile and send SUSAR Gap Packs
- Maintain and update expedited email distribution lists
- Reconcile compliance metrics
- Support generation of overall distribution/submission compliance metrics
- Monitor regulatory intelligence databases for regulation updates and provides country specific reporting information to support the development of Safety Reporting Plans
- Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate
- Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process
- Attends Department meetings
Qualifications:
Minimum Required:
- Must have sufficient experience and a demonstrated knowledge and understanding of global safety reporting regulations and guidelines including the FDA, ICH, & EU Regulations and Requirements for Pharmacovigilance
- Knowledge of the ARGUS Safety Database
- Minimum 2 years of experience in clinical trial drug safety in the Pharma/CRO industry
- Experience with EMA EudraVigilance, UK MHRA and other recognised reporting portals
- BA/BS preferred
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Ready to apply?
Apply to Precision Medicine Group
COMPANY DESCRIPTION:
A career here is life-enhancing.
At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here.
Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.
Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.
At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.
For more information, visit www.Synergbiopharma.com
POSITION OVERVIEW:
The Global Regulatory Lead Partner supports Global Regulatory Leads in assigned therapeutic areas and serves as the accountable global regulatory point of contact for designated products. The individual provides regulatory leadership for life‑cycle management, maintenance of established products, and execution of global regulatory submissions. This role drives results through regulatory science expertise, strong communication, and analytical capabilities, ensuring high‑quality regulatory strategies and deliverables for assigned products.
WORK LOCATION:
Remote position based in Bangalore, Chennai, Hyderabad, or Mumbai, with pan-India operations.
KEY RESPONSIBILITIES:
(This list is not exhaustive and may be supplemented or changed as necessary.)
- Ensure maintenance of global registrations for assigned products, including US and EU markets.
- Lead and execute regulatory activities supporting life‑cycle management, including submission strategy development, timeline definition, prioritization, assembly review, and identification of regulatory risks/challenges.
- Manage regulatory agency communications and submissions, including responses to agency questions, labeling negotiations, updates, and periodic reports.
- Coordinate SMEs to develop response strategies and author/review responses to health authority requests.
- Support labeling discussions, updates, and filings across CCDS, USPI, SmPC, and country‑specific labels.
- Provide regulatory input for annual reports, renewal applications, and aggregate safety reports (e.g., PSURs, PADERs).
- Conduct regulatory review for tender bid applications and assess country requests for registration deletions.
- Support preparation of ancillary documents required for product registrations in global markets.
- Follow through on agency commitments and ensure timely, high‑quality regulatory deliverables.
- Conduct research and review of US, EU, and other relevant regulatory guidelines, precedence, and competitive intelligence to inform regulatory strategy.
- Collaborate with Regulatory Operations, Clinical Safety, Labeling, Regulatory CMC, and other functional partners to ensure alignment and execution of regulatory strategy.
QUALIFICATIONS AND REQUIREMENTS:
Education:
- Bachelor's degree or higher in a relevant field such as pharmaceuticals, chemistry, or regulatory affairs.
Experience:
- 5+ years of experience in regulatory affairs and/or regulatory framework of major health authorities
- Experience working as a lead in Regulatory Affairs across two or more major geographic areas, and prior experience with both small molecules and biologics. Has sufficient regulatory knowledge to integrate inputs from other countries/regions to develop a global strategy and can develop and lead execution of holistic regulatory strategy while considering risk/opportunity, timeline, resource.
- Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends. Understands scientific and clinical data sufficiently to ask questions and make suggestions about cross-functional topics to influence overall development strategy and to assess regulatory implications and develop regulatory strategy.
- Regulatory experience with pre and post approval lifecycle management, interactions with Health Authorities, leading cross-functional regulatory teams, developing and implementing regulatory strategies with a proven track record of significant regulatory accomplishments.
- Strong business acumen and ability to make sound decisions that contribute positively to the business.
- Strong strategic skills and the ability to balance short-term needs with long-term vision.
- Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism.
Skills and Attributes:
- Excellent written and verbal communication skills.
- Strong negotiating skills and ability to think creatively and develop innovative solutions.
- Strong organizational and project management abilities.
- Strong analytical skills with high attention to detail.
- Understanding of regulatory filing requirements.
- Knowledge of ICH guidance and routine regulatory maintenance requirements.
- Ability to manage multiple priorities and work independently in a fast-paced environment.
- Proactive, detail-oriented, and self-motivated with a strong work ethic.
Ready to apply?
Apply to Syner-G
Staff Software Engineer
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You’ll join a team building a universal reporting and analytics platform: a 100% serverless, event‑driven system that powers embedded BI dashboards, scheduled reporting, usage analytics, and identity synchronization across commercial AWS and GovCloud environments.
This platform supports thousands of organizations and is deployed across multiple AWS regions and partitions, with a strong emphasis on reliability, security, and operational excellence.
As a Staff Software Engineer, you’ll own features end‑to‑end — from infrastructure design to backend services to frontend experiences — while mentoring others and shaping the technical direction of the platform.
What You’ll Do
- Design and build event‑driven serverless services using AWS Lambda, EventBridge, SQS, and Step Functions
- Own and evolve AWS CDK (v2) infrastructure for multiple interdependent services with multi‑account, multi‑region deployments
- Build and maintain high‑throughput analytics pipelines, ingesting, transforming, and storing events at scale using Kinesis, S3, and Athena
- Develop and enhance a React-based SPA that embeds BI dashboards with Amazon QuickSight
- Write production‑grade TypeScript across the full stack with strict type safety and clean architecture
- Design DynamoDB single‑table schemas and PostgreSQL data models for scalable, low‑latency access
- Define, version, and consume event contracts across distributed services
- Build and maintain CI/CD pipelines using self‑mutating CDK Pipelines
- Champion observability and operational excellence through structured logging, distributed tracing, dashboards, and alerts
- Conduct thoughtful code reviews and mentor junior and mid‑level engineers
What You’ll Bring
Required Qualifications
- 12+ years of experience delivering secure, scalable applications in agile environments
- Strong ability to communicate complex technical and AI‑related concepts to diverse stakeholders
- Proven experience leading projects, influencing engineering culture, and mentoring teams — including AI‑augmented development workflows
- Bachelor’s degree in Computer Science, Engineering, Mathematics, or equivalent professional experience
- Hands‑on experience with:
- TypeScript, JavaScript, React
- AWS core services: Lambda, API Gateway, DynamoDB, S3, SQS, EventBridge, Secrets Manager, KMS, CloudWatch (or equivalent services in other public clouds)
- Infrastructure as Code, specifically AWS CDK v2
Nice to Have (We’ll Support You If You Don’t Yet)
- Amazon Athena and AWS Glue
- Amazon QuickSight
- PostgreSQL and Amazon Aurora
- Experience designing and operating serverless architectures at scale
About Us
Diligent is the AI leader in governance, risk and compliance (GRC) SaaS solutions, helping more than 1 million users and 700,000 board members to clarify risk and elevate governance. The Diligent One Platform gives practitioners, the C-Suite and the board a consolidated view of their entire GRC practice so they can more effectively manage risk, build greater resilience and make better decisions, faster.
Learn more at diligent.com or follow us on LinkedIn and Facebook
What Diligent Offers You
- Creativity is ingrained in our culture. We are innovative collaborators by nature. We thrive in exploring how things can be differently both in our internal processes and to help our clients
- We care about our people. Diligent offers a flexible work environment, global days of service, comprehensive health benefits, meeting free days, generous time off policy and wellness programs to name a few
- We have teams all over the world. We may be headquartered in New York City, but we have office hubs in Washington D.C., Vancouver, London, Galway, Budapest, Munich, Bengaluru, Singapore, and Sydney.
- Diversity is important to us. Growing, maintaining and promoting a diverse team is a top priority for us. We foster and encourage diversity through our Employee Resource Groups and provide access to resources and education to support the education of our team, facilitate dialogue, and foster understanding.
Diligent created the modern governance movement. Our world-changing idea is to empower leaders with the technology, insights and connections they need to drive greater impact and accountability – to lead with purpose. Our employees are passionate, smart, and creative people who not only want to help build the software company of the future, but who want to make the world a more sustainable, equitable and better place.
Headquartered in New York, Diligent has offices in Washington D.C., London, Galway, Budapest, Vancouver, Bengaluru, Munich, Singapore and Sydney. To foster strong collaboration and connection, this role will follow a hybrid work model. If you are within a commuting distance to one of our Diligent office locations, you will be expected to work onsite at least 50% of the time. We believe that in-person engagement helps drive innovation, teamwork, and a strong sense of community.
We are a drug free workplace. Diligent is proud to be an equal opportunity employer. We do not discriminate based on race, color, religious creed, sex, national origin, ancestry, citizenship status, pregnancy, childbirth, physical disability, mental disability, age, military status, protected veteran status, marital status, registered domestic partner or civil union status, gender (including sex stereotyping and gender identity or expression), medical condition (including, but not limited to, cancer related or HIV/AIDS related), genetic information, or sexual orientation in accordance with applicable federal, state and local laws. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also Diligent's EEO Policy and Know Your Rights. We are committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, you may contact us at recruitment@diligent.com.
To all recruitment agencies: Diligent does not accept unsolicited agency resumes. Please do not forward resumes to our jobs alias, Diligent employees or any other organization location. Diligent is not responsible for any fees related to unsolicited resumes.
Ready to apply?
Apply to Diligent Corporation
Staff Software Engineer
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Position Overview:
As a Staff Software Engineer at Diligent, you’ll create robust, scalable, and secure microservices that power our SaaS platform for governance. You’ll leverage AWS (serverless or migrations) with TypeScript, own services end-to-end (code, deployment, monitoring), drive architecture discussions, and regularly demo to the department. A critical part of this role is shaping our AI strategy: you’ll lead design decisions, embed AI responsibly into systems, and mentor teams on AI capabilities, safety, and governance.
Key Responsibilities:
- Champion the design and delivery of secure, high-performance microservices on AWS, driving architecture decisions and empowering team members through mentorship.
- Set technical direction across multiple teams, spotting system pain points and proposing improvements.
- Pioneer AI-driven solutions by advising on model capabilities, crafting effective prompt strategies, and embedding governance and monitoring into development workflows.
- Partner with Product, Security, and DevOps to shape technical roadmaps, ensure compliance, and seamlessly integrate AI features that deliver real business value.
- Continuously elevate our toolkit by evaluating and piloting cutting-edge technologies (including AI toolchains), optimizing for performance, cost efficiency, and developer productivity.
- Own projects end-to-end—from ideation and prototyping to deployment, monitoring, and iteration—ensuring resilient, maintainable systems and top-notch code quality.
- Mentor engineers in best practices and AI-augmented workflows, fostering a culture of experimentation, learning, and ethical AI adoption.
- Stay ahead of emerging AI trends and regulations, proactively adapting designs and practices to meet evolving standards and steer future innovation.
Required Experience/Skills
- 7–10 years delivering secure, scalable applications in agile environments.
- Understanding of model architectures (e.g., transformer vs. retrieval-augmented), bias and safety concerns, prompt engineering, and proven experience shaping AI strategy and mentoring teams on responsible AI use. Ability to architect AI systems with embedded monitoring and governance.
- Design and review scalable, high-performance system architectures, APIs, and data models, while writing high-quality, testable code in Node.js, React, and TypeScript/JavaScript, including reusable libraries and frameworks.
- Lead end-to-end DevOps and platform engineering, including CI/CD pipeline design with strong guardrails, infrastructure-as-code and modern deployment strategies, cloud observability and incident response, and cost-aware architecture and capacity planning across AWS, Azure, and GCP
- Integrates security best practices (IAM, secrets management) into all work, including AI components, and embeds bias/privacy checks in delivery pipelines.
- Strong communication of technical and AI-related concepts to diverse stakeholders; proven ability to lead projects, influence engineering culture, and mentor peers in AI-augmented workflows.
- Degree in Computer Science, Engineering, Mathematics, or equivalent experience.
*** Only Bangalore candidates may apply
About Us
Diligent is the AI leader in governance, risk and compliance (GRC) SaaS solutions, helping more than 1 million users and 700,000 board members to clarify risk and elevate governance. The Diligent One Platform gives practitioners, the C-Suite and the board a consolidated view of their entire GRC practice so they can more effectively manage risk, build greater resilience and make better decisions, faster.
Learn more at diligent.com or follow us on LinkedIn and Facebook
What Diligent Offers You
- Creativity is ingrained in our culture. We are innovative collaborators by nature. We thrive in exploring how things can be differently both in our internal processes and to help our clients
- We care about our people. Diligent offers a flexible work environment, global days of service, comprehensive health benefits, meeting free days, generous time off policy and wellness programs to name a few
- We have teams all over the world. We may be headquartered in New York City, but we have office hubs in Washington D.C., Vancouver, London, Galway, Budapest, Munich, Bengaluru, Singapore, and Sydney.
- Diversity is important to us. Growing, maintaining and promoting a diverse team is a top priority for us. We foster and encourage diversity through our Employee Resource Groups and provide access to resources and education to support the education of our team, facilitate dialogue, and foster understanding.
Diligent created the modern governance movement. Our world-changing idea is to empower leaders with the technology, insights and connections they need to drive greater impact and accountability – to lead with purpose. Our employees are passionate, smart, and creative people who not only want to help build the software company of the future, but who want to make the world a more sustainable, equitable and better place.
Headquartered in New York, Diligent has offices in Washington D.C., London, Galway, Budapest, Vancouver, Bengaluru, Munich, Singapore and Sydney. To foster strong collaboration and connection, this role will follow a hybrid work model. If you are within a commuting distance to one of our Diligent office locations, you will be expected to work onsite at least 50% of the time. We believe that in-person engagement helps drive innovation, teamwork, and a strong sense of community.
We are a drug free workplace. Diligent is proud to be an equal opportunity employer. We do not discriminate based on race, color, religious creed, sex, national origin, ancestry, citizenship status, pregnancy, childbirth, physical disability, mental disability, age, military status, protected veteran status, marital status, registered domestic partner or civil union status, gender (including sex stereotyping and gender identity or expression), medical condition (including, but not limited to, cancer related or HIV/AIDS related), genetic information, or sexual orientation in accordance with applicable federal, state and local laws. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also Diligent's EEO Policy and Know Your Rights. We are committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, you may contact us at recruitment@diligent.com.
To all recruitment agencies: Diligent does not accept unsolicited agency resumes. Please do not forward resumes to our jobs alias, Diligent employees or any other organization location. Diligent is not responsible for any fees related to unsolicited resumes.
Ready to apply?
Apply to Diligent Corporation