Manager – Medical Affairs (Pharmacovigilance)
Location: Begumpet, Hyderabad, India
Work Mode: On-site
Department: Medical Affairs / Pharmacovigilance
Employment Type: Full-time
Job Overview
We are seeking an experienced Manager – Medical Affairs (Pharmacovigilance) to lead pharmacovigilance operations, medical review activities, and safety reporting processes. This role is responsible for ensuring end-to-end drug safety oversight, regulatory compliance, and timely submission of safety reports in alignment with global pharmacovigilance standards.
The position requires strong medical expertise, hands-on pharmacovigilance experience, and the ability to manage safety operations, regulatory submissions, and cross-functional medical review activities.
Key Responsibilities
Pharmacovigilance Operations & Medical Review
Lead end-to-end pharmacovigilance and medical review activities.
Perform detailed medical assessment of adverse event (AE) and serious adverse event (SAE) cases.
Review, validate, and approve safety narratives and case-related clinical data.
Ensure accurate coding, classification, and evaluation of safety information.
Aggregate Safety Reporting
Author and review aggregate safety reports, including:
PSUR (Periodic Safety Update Report)
DSUR (Development Safety Update Report)
PADER (Periodic Adverse Drug Experience Report)
RMP (Risk Management Plan)
Ensure timely preparation and submission of regulatory safety documents.
Maintain compliance with global pharmacovigilance reporting requirements.
Regulatory Compliance & Quality Assurance
Ensure adherence to applicable pharmacovigilance regulations and guidelines.
Support internal and external audits, regulatory inspections, and quality assessments.
Implement corrective and preventive actions (CAPA) where required.
Maintain inspection-ready documentation and safety records.
Medical Governance & Stakeholder Engagement
Conduct medical review meetings and safety case discussions.
Provide medical and pharmacovigilance expertise across ongoing projects.
Collaborate with internal teams and external clients on safety-related matters.
Ensure alignment of safety decisions with regulatory and clinical standards.
Team Leadership & Operational Management
Manage pharmacovigilance team performance, workload allocation, and productivity.
Provide guidance, training, and mentorship to team members.
Ensure efficient case processing and timely closure of safety activities.
Drive continuous improvement in PV processes and workflows.
Safety Data Management
Oversee review and interpretation of patient safety data.
Ensure accurate documentation and maintenance of safety databases.
Monitor case quality and ensure compliance with SOPs and regulatory standards.
Required Qualifications
Education
MBBS degree with valid MCI registration/certification (mandatory)
Experience
Fresher Eligible: No
Required Experience: Minimum 6–8 years of experience in Pharmacovigilance / Drug Safety / Medical Affairs (PV-focused roles)
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