MBBS Job at Viatris – Product Safety Physician Role in Hyderabad
Looking for an exciting MBBS Job in the pharmaceutical industry? Viatris is hiring for the position of Aggregate Report Review – Product Safety Physician – Pharmacovigilance in Hyderabad. This opportunity is ideal for experienced medical professionals seeking Viatris careers, especially those looking for an advanced MD Job or senior-level medical jobs in Hyderabad within global pharmacovigilance operations.
Job Details:
- Job Position: Aggregate Report Review – Product Safety Physician – Pharmacovigilance
- Location: Hyderabad
About The Company
Viatris is a global healthcare company committed to improving patient access to high-quality, trusted medicines across more than 165 countries. With a diverse portfolio that includes brand-name products, generics, and complex generics, Viatris focuses on Access, Leadership, and Partnership to address evolving healthcare needs while maintaining strong standards in patient safety and pharmacovigilance excellence.
Job Description
The Medical Reviewer will be responsible to assist in the global pharmacovigilance (PV) activities within global PV for Viatris in accordance with Company, international standards and regulatory requirements, as assigned. This MBBS Job and preferred MD Job opportunity involves high-level aggregate report review and strategic safety responsibilities in a global pharmaceutical environment.
Qualifications
- MBBS
- MD (Preferred)
Key Responsibilities
Product Safety and Aggregate Reports
- Responsible for the end-to-end safety of the products’ value chain
- Coordinating medical review of Periodic Safety Update Reports (PSUR), Periodic Adverse Drug Experience Reports (PADER), and Addendum to Clinical Overview (ACO) related activities (including but not limited to writing & medical review) within health regulatory timelines
- Managing Development Safety Update Reports (DSUR) related activities in collaboration with the clinical safety team, including the development of the safety strategy and safety management plan
- Building a safety strategy with internal and/or external stakeholders
- Training team members on assigned therapeutic areas/product portfolios
Safety Plans & Cross-Functional Representation
- Develop, review, and update specific safety plans in liaison with PV operations team, Clinical development, regulatory affairs, and other cross-functional departments
- Represent the company from a clinical safety perspective in cross-functional and/or oversight committee meetings
Risk Management Plans (RMP)
- Coordinating RMP-related activities, including the collection of data, RMP writing, and medical review
- Handling requests from regulatory affairs and the PV department in a timely manner
Signal Management
- Signal detection by the company’s methodology
- Medical review of signal reports
- Communication and escalation to the relevant signal boards
Product Information & Labelling
- Providing medical/safety inputs in Product Information and labelling issues
- Develop, update, and maintain CCDS and/or RSI in line with the product’s development phase
Health Authority Responses
- Preparing responses to Regulatory Authority questions related to safety issues
- Conducting medical review
- Training team members
Stakeholder Liaison
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Liaise with internal and external stakeholders and Viatris drug safety teams
PV Department Projects
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Assist in the Pharmacovigilance department projects such as PV Quality Management Systems and Clinical Overview Addendum(s)
Medical Safety Expertise
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Provide medical safety expertise and training
Regulatory Knowledge
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Keep current with professional and pharmacovigilance regulations
Team Guidance
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Provide guidance to senior/drug safety technical assistants, specialists and medical reviewers
SOP Writing
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Writing & update of Standard Operating Procedures (SOP)
Issue Escalation
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Escalate issues of importance and track until resolution
