Job Description Drug Safety Physician

We are seeking a drug physician in Biocon Biologics Pharmacovigilance who independently or in association with senior physicians will be responsible for continuous evaluation of the safety profile of company products through adverse event monitoring, supporting clinical trial PV safety activities, overseeing aggregate report reviews, safety signal and risk management activities and drive proactive implementation of risk management initiatives to meet global regulatory requirements. Involved in all safety surveillance activities, which may include monitoring of adverse event and all other safety information to manage the safety profile of the company products

• Collaborates with, medical monitors and other functional groups in identification, analysis, and reporting of possible safety-related trends or concerns.

• Responsible for the evaluation of safety data from pre-clinical studies, clinical studies, literature and other sources to establish safety profile of company products to manage risk to the patients





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

• Discuss results of data evaluation with pharmacovigilance safety review team, drug safety committee and/or other key stakeholders

• Provides inputs to literature search strategy and review to effectively determine appropriate and relevant literature for the purposes of safety analysis.

• Responsible for the review of the Risk Management Plans (RMP)/Risk Evaluation and Mitigation Strategy (REMS) providing expertise to the medical content of the safety specification, risk management plan, risk minimisation measures including the locally implemented risk minimisation measures and drives the implementation of risk minimisation activities in accordance with global regulatory requirements.

• Provides medical input in ensuring that risk minimisation st

📌 Clinical Research Doctor (Bengaluru)
🏢 BIOCON BIOLOGICS
📍 Bengaluru