Senior Medical Safety Reviewer

4 weeks ago

Hyderabad, India Viatris Full time

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; and

Partnership – 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 here’s 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 task

2. 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 assessment

4. Responsible for assisting in:

• CCDS development, review and update

• Maintenance of Reference Safety Information

5. Health Authority Responses

• Assists or prepares and conducts medical review on responses to Regulatory Authority queries related to safety issues

6. Provides safety input into Medical Risk Assessments (MRAs), and follows-up on the quality issues having safety implications

7. Reviews and provides medical/safety inputs to the Product Information and other labelling queries

8. Provides medical safety expertise and training to other personnel, as necessary

9. Assist in writing & update of Standard Operating Procedures (SOP), or any other project/s as assigned where PV is involved, as deemed necessary


Education:

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

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