À propos de ce poste Senior Pharmacovigilance Specialist, Regulatory Intelligence and Submissions chez ProPharma
For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
This is an exciting opportunity for a detail-oriented PV professional who enjoys working in a fast-paced, global environment and has hands-on experience with safety databases, regulatory reporting requirements, and health authority submissions.
What You'll Do
Adverse Event Submission & Compliance
- Manage and monitor expedited and non-expedited Individual Case Safety Report (ICSR) submissions and exchanges.
- Ensure compliance with global pharmacovigilance reporting requirements and internal procedures.
- Conduct monthly ICSR reconciliation activities with clients and safety partners.
- Support gateway-to-gateway testing for health authority submissions and safety partner exchanges.
- Assist with the investigation, documentation, and resolution of submission-related deviations and CAPAs.
Periodic Safety Reporting
- Generate Argus-based line listings and summary tabulations for periodic safety reports.
- Assist in the creation, validation, and quality review of custom reports and reporting outputs.
- Support the setup, verification, and maintenance of periodic reporting requirements across global markets.
- Coordinate periodic report submissions in compliance with local regulatory requirements.
- Partner with the pharmacovigilance leadership team to support reporting services and operational excellence.
Regulatory Intelligence
- Research, collect, and maintain global pharmacovigilance reporting requirements for pharmaceutical, biologic, and medical device products.
- Conduct monthly regulatory surveillance and impact assessments.
- Support regulatory intelligence tools, mailboxes, tickets, queries, and ad hoc projects.
- Provide guidance and support on evolving PV regulations and reporting obligations.
Systems, Testing & Process Improvement
- Perform Performance Qualification (PQ) testing for Argus upgrades, patches, and custom developments.
- Support implementation and validation of new territory-specific and custom E2B profiles.
- Participate in data migration testing and submissions-related system enhancements.
- Contribute to projects aimed at improving efficiency, quality, and system performance.
xEVMPD Management
- Prepare and maintain xEVMPD submissions, updates, removals, and new product entries within required timelines.
- Conduct peer review and quality control of xEVMPD submissions.
- Support bulk updates, QPPV changes, master file location updates, and developmental product registrations.
What We're Looking For
Education
- High school diploma required.
- Post-secondary education in a life sciences discipline is preferred.
- Equivalent professional experience in pharmacovigilance regulatory submissions or regulatory intelligence will also be considered.
Experience
- Minimum of 3 years' experience working with pharmacovigilance safety databases.
- Experience with safety reporting, ICSR submissions, E2B exchanges, and regulatory compliance activities preferred.
- Experience with Oracle Argus Safety or similar safety databases is highly desirable.
- Knowledge of xEVMPD and global pharmacovigilance regulations is an advantage.
Skills & Competencies
- Strong attention to detail and commitment to quality.
- Excellent verbal and written communication skills.
- Strong organizational and problem-solving abilities.
- Ability to manage multiple priorities and adapt to changing business needs.
- Comfortable working independently while collaborating effectively within cross-functional and global teams.
- Proficiency in Microsoft Office applications, including Outlook, Word, and Excel.
Why Join Us?
- Work with a global team of pharmacovigilance and regulatory experts.
- Gain exposure to international safety reporting requirements and health authority interactions.
- Contribute to meaningful projects that support patient safety and regulatory compliance worldwide.
- Develop your expertise across submissions, regulatory intelligence, testing, and PV systems in a dynamic and growing environment.
If you're a proactive pharmacovigilance professional looking to broaden your regulatory and submissions expertise while making an impact on global patient safety, we'd love to hear from you.
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We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
