Primary Responsibilities:

The Safety Surveillance Physician (Std.) will implement and support further development of proactive and systematic product surveillance strategies, by performing activities such as, but not limited to:

• Performance of alert triage within pre-defined timelines, by conducting systematic reviews of cases and aggregate data in the safety databases and reviewing trends, as applicable, to identify potential safety signals.
• Performance of signal validation and support for signal evaluation through the review, analysis, interpretation, and summary of case and aggregate safety data from various sources such as
  clinical, post marketing, observational studies, medical literature, health authority databases, and product quality databases.
• Assistance in the development and implementation of strategies for the surveillance of post-marketing data, as well as the development of product specific medical safety assessments.
• Participation as a member of the matrix teams to address product-specific safety issues.
• Support for the evaluation of novel and computer-assisted tools and methodologies for the analysis of safety data.
• Tracking of signal disposition and signal management activities in the relevant tracking tool.
• Support for maintenance of documentation relevant to signal detection and management activities.

Secondary Responsibilities:

• Effectively organize work to complete the assigned tasks to meet deadlines.
• Ensure the assigned tasks are delivered 100% on time or before, as per project SLA.
• Demonstrate Quality of Work & Commitment through excellence in work, ensure correctness and completeness in deliverables with minimum OR no re-work.
• Support in review of work done by peer teammates, on need basis.
• Alerts and escalates to senior members as required, whenever project deliverable risks are visualized, OR issues encountered impacting the delivery schedule.
• Ensure error-free and acceptable quality in assigned deliverables.
• Responsible for ensuring training compliance and timesheet compliance.
• Ensure that all assigned goals [e.g. utilization and efficiency] are met as per set standards for the performance year.
• Be aware of and comply with the QMS/ ISMS & PIMS Policy.
• Report any potential or actual Security Breaches to the regional and/or global DPO & Security Incidents to CISO/ applicable distribution list.
• Contribute towards the achievement of Quality Objectives.

Candidate Profile:

• Board-certified Medical Physician
• Technical skills: Ability to analyze, interpret, and present complex data in a concise and understandable scientific manner, both orally and in written format.
• Attention to detail: Diligence in record-keeping and records organization, ability to manage a high workload and critical issues, computer-literate and proficient in MS Office applications.
• Interpersonal skills: team player, displays initiative, strong communication, and presentation skills
• Internal and external networking skills, strong collaborative and interpersonal skills, results-oriented and ability to independently create and deliver, ability to thrive in a global, cross-functional environment.
• Minimum of 3 to 5 years of relevant experience in identified functional domain/ business workstream

Primary Responsibilities:

• Awareness and understanding of relevant GVP modules.
• Perform medical review of non-serious & serious ICSRs with emphasis on seriousness, expectedness, causality & narrative etc. without missing on quality & compliance.
• Experience of medical review of ICSRs received from sources such as Spontaneous, Literature, Regulatory Authority, Solicited and Clinical trials.
• Experience across multiple therapeutic areas such as Oncology, Respiratory, Immunology, Neuroscience, Rare diseases etc.
• Support triage of cases and determine seriousness and relatedness across products as assigned.
• Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labelling and review narrative.
• Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas.
• Involve in process improvement activities such as implementation of quality control process.
• Provide medical guidance and expert opinion on the cases to the data entry associates and quality reviewers to help resolve queries.
• Identify and resolve case issues, coordinate with client therapeutic teams and within functional team and manage as appropriate.
• Maintain PV expertise and understanding of international safety regulations and guidelines.
• Responsible for completing the MR activities in the safety database within the stipulated time to comply with service level agreements and regulatory timelines.
• Provide timely feedback to case processors on the errors/ discrepancies noted.
• Assist in training/mentoring of other case processing/medical review personnel as necessitated.
• Adapt to different client case processing conventions and multi-task as per business needs.
• Perform ad-hoc tasks as advised by the team lead/manager with quality and compliance as per project requirement.
• Participate in organizational activities to meet objectives suitable for the role/area of expertise.

Candidate Profile:

• Medical Physician with at least 2 years of experience as Medical Reviewer for ICSRs.
• Must possess thorough knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines and other regulatory requirements.
• Training and mentoring skills (GVP concepts & medical aspects such as disease condition, product portfolio etc).
• Must have hands-on experience with MS Office applications (Outlook, Excel, Word, Power Point etc).