Mylan Laboratories -Openings for Drug Safety Physician

Job Description

•Be the pharmacovigilance expert/ medical writer for assigned biologics, maintain current knowledge of full portfolio and safety profiles.

•Ensuring effective proactive safety strategies for assigned biosimilars products; provision of recommendations and guidance concerning potential and/or established product risks and suitable risk management and mitigation strategies.

•Responsible for ongoing comparative safety and benefit -risk evaluation for te assigned biosimilar products. This includes the medical evaluation of single cases; signal detection and evaluation activities; compilation of periodic safety reports, drafting of risk management plans and other regulatory submission documents.

•Responsible for assisting in Periodic Safety Reports Updates (PSUR) and Addendum to Clinical overview (ACO), dSUR etc.related activities (including but not limited to report writing & medical review, handling of requests received from Central & Local Regulatory Affairs and PV departments) within respect of timelines and any other related task for all Mylan medicinal products and biologics.

Post Name : Drug Safety Physician

Qualification: MBBS

Location: Hyderabad

Vacancies: NA

Salary : NA

Contact Details:

Company : Mylan Laboratories

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Mylan Laboratories -Openings for Drug Safety Physician