Pharmaceutical Safety Expert
1 month ago
About Biocon Biologics
">Biocon Biologics is a leading global biopharmaceutical company that develops and manufactures innovative therapies for patients worldwide.
Job Summary
">We are seeking an experienced Pharmaceutical Safety Expert to join our Pharmacovigilance team in Bangalore, India. This role will involve working independently or collaboratively with senior experts to evaluate the safety profile of our products through adverse event monitoring, clinical trial PV activities, aggregate report reviews, safety signal management, and risk mitigation strategies.
Key Responsibilities:
">- Evaluate safety data from pre-clinical studies, clinical trials, literature, and other sources to establish product safety profiles and manage risks to patients.
- Collaborate with medical monitors and functional groups to identify, analyze, and report possible safety-related trends or concerns.
- Provide medical input into identifying and utilizing appropriate information sources and database searches for signal evaluation.
- Discuss data evaluation results with pharmacovigilance safety review teams, drug safety committees, and key stakeholders.
- Contribute to literature search strategies and reviews to determine relevant literature for safety analysis.
- Review Risk Management Plans (RMP) and Risk Evaluation and Mitigation Strategies (REMS) and provide expertise on medical content and risk minimization measures.
- Develop and implement risk minimization activities in accordance with global regulatory requirements.
- Provide medical input to ensure accurate safety evaluation documents and deliver clear conclusions in response to internal or regulatory authority requests.
- Participate in internal pharmacovigilance committee meetings, joint safety meetings with partners, and support audit/inspection preparation and CAPA management.
- Follow good pharmacovigilance practices (ICH, Eudravigilance, local regulations, etc.) and maintain personal readiness for internal audits or regulatory inspections.
- Train and mentor team members and demonstrate leadership skills, interacting collaboratively and effectively in a team environment.
Requirements:
">- MBBS/PhD/MD degree with 7+ years of pharmacovigilance experience in the pharmaceutical industry, clinical care setting, or academia.
- Knowledge of the biopharmaceutical industry, drugs, and indications, as well as applicable guidelines, regulations, and best practices for pharmacovigilance activities.
- High degree of professionalism, maturity, business understanding, and passion, with strong written and verbal communication skills and 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 like MS Office tools (Excel, PowerPoint, Microsoft Word, etc.).
Benefits and Salary:
">This role offers an attractive salary package, estimated to be ₹18,00,000 - ₹22,00,000 per annum, depending on qualifications and experience. Benefits include opportunities for professional growth, recognition, and rewards based on performance, as well as a supportive work environment.
Location:
">Bangalore, India.
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