Product Safety Physician - Pharmacovigilance

Why This Role Matters
Aggregate Report Review Physicians are central to ensuring global product safety, regulatory compliance, and benefit-risk balance across the product lifecycle. By overseeing PSURs, PADERs, DSURs, RMPs, and signal management activities, this role directly impacts patient safety, labeling decisions, and regulatory confidence in marketed and developmental products.

Job Description
Viatris is hiring an Aggregate Report Review – Product Safety Physician (Pharmacovigilance) for its Hyderabad location (On-site, Full-Time). The Medical Reviewer will support global pharmacovigilance activities, ensuring compliance with international safety regulations and company standards. The role involves end-to-end oversight of aggregate safety reports, risk management strategies, signal evaluation, and health authority interactions.

Key Features of the Role:
• Location: Hyderabad, Telangana
• Employment Type: Full-time (On-site)
• Global pharmacovigilance exposure
• Leadership in aggregate safety reporting
• Collaboration with regulatory, clinical, and cross-functional teams
• Senior-level safety oversight role

Responsibilities
• Coordinate and conduct medical review of PSURs, PADERs, ACOs within regulatory timelines
• Manage DSUR activities and collaborate with clinical safety teams
• Develop safety strategies and safety management plans
• Coordinate Risk Management Plan (RMP) preparation and medical review
• Lead signal management activities including detection, validation, review, and escalation
• Provide medical inputs for labeling, CCDS, and RSI updates
• Prepare responses to Health Authority safety queries
• Represent clinical safety perspective in oversight committees
• Train team members on assigned therapeutic portfolios
• Support PV Quality Management Systems and departmental projects
• Develop and update SOPs
• Escalate and track critical safety issues until resolution
• Maintain updated knowledge of global pharmacovigilance regulations

Required Qualifications
• MBBS (mandatory)
• MD (preferred)
• Minimum 8 years of aggregate report review experience
• Minimum 10 years pharmaceutical industry experience
• Strong knowledge of pharmacovigilance guidance and global regulations

Educational Requirements:
• MBBS (mandatory)
• MD (preferred)

Experience and Skills:
• Extensive experience in PSUR, PADER, DSUR, RMP preparation and review
• Strong understanding of signal management processes
• Expertise in labeling documents (CCDS, RSI)
• Health Authority interaction experience
• Leadership and team training capability
• Cross-functional collaboration skills
• Strong analytical and medical judgment ability

Age Eligibility:
As per company norms

Salary Insights
Compensation not disclosed. Senior-level industry remuneration expected based on experience and expertise.

Company Overview
Viatris is a global pharmaceutical company committed to expanding access to high-quality medicines worldwide. With a diversified portfolio spanning branded medicines, generics, and complex generics, Viatris focuses on sustainable healthcare solutions through access, leadership, and partnership.

FAQs

Is aggregate report experience mandatory?
Yes, a minimum of 8 years of aggregate report review experience is required.

Is MD mandatory?
MD is preferred but MBBS is mandatory.

Does the role include signal management?
Yes, signal detection, validation, and escalation are core responsibilities.

Is this a remote role?
No, this is an on-site role based in Hyderabad.

Will the role involve Health Authority interactions?
Yes, preparation and review of regulatory responses are included.

Application Tips
• Clearly highlight aggregate report review experience (PSUR, DSUR, PADER, RMP)
• Mention experience with CCDS/RSI updates
• Showcase leadership and training experience
• Demonstrate signal management expertise
• Emphasize regulatory interaction and global PV exposure