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Global Drug Safety Expert

2 weeks ago

Bengaluru, Karnataka, India Biocon Biologics Full time

About the Role

Biocon Biologics is seeking a highly skilled Drug Safety Physician to lead our pharmacovigilance team. The successful candidate will be responsible for evaluating the safety profile of our company's products and developing strategies to minimize risks to patients.

Key Responsibilities

  1. Develop and maintain product safety profiles to ensure compliance with global regulatory requirements

  2. Monitor adverse events and other safety information to manage the safety profile of company products

  3. Collaborate with medical monitors and other functional groups to identify, analyze, and report possible safety-related trends or concerns

  4. Evaluate safety data from pre-clinical studies, clinical studies, literature, and other sources to establish the safety profile of company products and manage risk to patients

  5. Provide medical input into the identification and utilization of appropriate sources of information and database searches to retrieve relevant data for signal evaluation

  6. Discuss results of data evaluation with pharmacovigilance safety review teams, drug safety committees, and/or other key stakeholders

  7. Provide inputs to literature search strategies and reviews to effectively determine appropriate and relevant literature for the purposes of safety analysis

  8. Review Risk Management Plans (RMP) / Risk Evaluation and Mitigation Strategy (REMS) and provide expertise on the medical content of the safety specification, risk management plan, and risk minimization measures

  9. Drive the implementation of risk minimization activities in accordance with global regulatory requirements

Requirements

  • M.B.B.S./P.H.D./M.D. with 7+ years of pharmacovigilance experience in the pharmaceutical industry, clinical care setting, or academia
  • Knowledge of the biopharmaceutical industry, drugs, and indications, with an understanding of applicable guidelines, regulations, and best practices for conduct of pharmacovigilance activities
  • Strong written and verbal communication skills, as well as strong interpersonal skills, with impeccable attention to detail
  • Ability to collaborate effectively with internal and external stakeholders at all levels and influence decision-making
  • Familiarity with common data processing software, such as MS Office tools (Excel, PowerPoint, Microsoft Word)