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Senior Medical Safety Reviewer - Pharmacovigilance

8.00 to 10.00 Years   Hyderabad   09 Apr, 2024
Viatris
Job LocationHyderabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaNot Mentioned
EmploymentTypeFull-time

Job Description

    At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.Viatris empowers people worldwide to live healthier at every stage of life.We do so via:Access Providing high quality trusted medicines regardless of geography or circumstance;Leadership Advancing sustainable operations and innovative solutions to improve patient health; andPartnership Leveraging our collective expertise to connect people to products and services.Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.Every day, we rise to the challenge to make a difference and heres how the Pharmacovigilance. (Senior Manager) Senior Safety Medical Reviewer role will make an impact:The Senior 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.Key responsibilities for this role include:1. To coordinate Periodic Safety Update Reports (PSUR) and Addendum to Clinical Overview (ACO) related activities (including but not limited to PSUR writing & medical review, handling of requests received from Global & Local Regulatory Affairs and PV departments) within respect of timelines and any other related task2. To coordinate Risk Management Plans (RMP) related activities (including but not limited to information assimilation, RMP writing and medical review, handling requests received from Global or local regulatory affairs and other stakeholders)3. Responsible for Signal Management related activity (including signal detection by, medical review of signal reports and their Validation and full assessment4. Responsible for assisting in:CCDS development, review and updateMaintenance of Reference Safety Information5. Health Authority ResponsesAssists or prepares and conducts medical review on responses to Regulatory Authority queries related to safety issues6. Provides safety input into Medical Risk Assessments (MRAs), and follows-up on the quality issues having safety implications7. Reviews and provides medical/safety inputs to the Product Information and other labelling queries8. Provides medical safety expertise and training to other personnel, as necessary9. Assist in writing & update of Standard Operating Procedures (SOP), or any other project/s as assigned where PV is involved, as deemed necessaryEducation:MBBS & MD (Preferrable)Minimum Experience / Training Required: Minimum of 8 Years of Experience with Aggregate Report Reviews 10 Years of pharmaceutical industry experience, preferably working within pharmacovigilance Knowledge of Pharmacovigilance Guidance/s,

Keyskills :
PharmacovigilancePSUR writingRisk Management PlansStandard Operating ProceduresPV activitiesSignal ManagementCCDS developmentHealth Authority Responses

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