Principal Physician, Patient Safety
New
IndiaFull-TimePrincipal
Salary not disclosed
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Job Details
Requirements
- Medical degree (MBBS, MD, or equivalent) from a recognized institution with completed clinical training.
- Extensive experience in clinical medicine and/or pharmacovigilance, drug safety, or clinical research environments.
- Strong knowledge of drug safety principles, adverse event reporting, and global regulatory frameworks (ICH GCP, GVP, and related guidelines).
- Experience in medical review of safety cases, including clinical trial and post-marketing data.
- Ability to assess benefit-risk profiles, interpret complex clinical data, and provide sound medical judgment.
- Strong communication skills with the ability to engage with stakeholders, regulators, and cross-functional teams.
- Experience in mentoring or guiding junior medical professionals is preferred.
- Ability to work in a matrix environment and manage complex, multi-stakeholder safety workflows.
- Strong analytical, decision-making, and scientific writing skills.
Responsibilities
- Provide medical oversight and leadership in pharmacovigilance activities, including adverse event evaluation, case review, and safety signal assessment.
- Review and interpret clinical and safety data, including serious and non-serious cases, literature reports, and clinical trial safety information.
- Contribute to the preparation and medical review of regulatory safety documents such as PBRERs, PSURs, DSURs, HHEs, and signal evaluation reports.
- Ensure accurate medical coding, narrative review, causality assessment, and compliance with global regulatory requirements and internal SOPs.
- Lead or support signal detection, validation, evaluation, and ongoing safety monitoring activities across assigned products.
- Provide medical input for risk management plans, safety surveillance strategies, and regulatory submissions.
- Act as a subject matter expert during audits, inspections, and client or regulatory interactions.
- Collaborate with cross-functional teams including data management, regulatory, clinical, and safety operations to ensure end-to-end safety governance.
- Mentor junior physicians and contribute to training, capability building, and knowledge sharing within pharmacovigilance teams.
- Participate in scientific discussions, therapeutic area initiatives, and continuous process improvement efforts.
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