Hetero Drugs Limited – Hiring for SR.MANAGER/AGM – MEDICAL SAFETY

Hetero is a globally renowned vertically integrated pharmaceutical player engaged in research and development, manufacturing, and marketing of high-quality chemical and biologic medicines across diverse therapeutic areas. Backed by 27+ years of expertise in the pharmaceutical industry, Hetero’s strategic business areas spread across APIs, Global Generics, Biosimilars and Custom Pharmaceutical Services. The company is among the largest producers of Active Pharmaceutical Ingredients (APIs) in the world.

Job Description

Senior Safety Physician:

A. Qualifications– M.B.B.S / MD

B. Experience- 7-9 Years of experience with at least 5-7 years in medical review function in a reputed pharmaceutical company or a CRO.

Responsibilities-

a) General-

• Team development & line management of medical reviewers
• Building the expertise and knowledge base of medical review function

b) ICSR Medical review-

• Medical oversight of ICSRs
• Final gate for ICSR review before reporting and for triaging
• Argus safety and/ or Aris-g experience mandatory
• Building and tracking metrics for medical review function

c) Aggregate Safety Report-

• Medical oversight of PSURs, PBRERs, PADERs
• Final gate for aggregate safety report review before reporting

d) Additional responsibilities-

• Training-
• Cross functional teams in CD&MA on medical aspects of pharmacovigilance function
• Inter departmental training RA/QA/ Manufacturing units for pharmacovigilance regulations and support the training group within CD&MA
• Medical monitoring of clinical trial cases – Support the core medical monitoring team from time to time
• Regulatory presentations – safety related at domestic and/ international, as required

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