Drug Safety Specialist

As a Drug Safety Specialist specializing in Safety Surveillance and Risk Management at Biocon Biologics, you will play a crucial role in ensuring the safety of our products by managing safety signal activities, developing risk management plans, overseeing aggregate report preparation and submission, responding to safety inquiries, and supporting clinical trial pharmacovigilance activities. You will be a key leader in monitoring safety compliance, influencing stakeholders, and serving as a subject matter expert on global safety regulations and guidelines. Your responsibilities will include supporting the signal management process, evaluating safety data, preparing Risk Management Plans, responding to safety inquiries from regulatory authorities and partners, collaborating with aggregate report vendors, and contributing to process improvements in aggregate reporting, signal management, and risk management plan preparation. Additionally, you will participate in pharmacovigilance audit/inspection preparation, ensure compliance with pharmacovigilance commitments, and collaborate with cross-functional teams for clinical studies. You will also be involved in device safety trend analysis, safety writing activities for biosimilar publications, training management support, and oversight of PV vendors. Your qualifications should include a Master's degree in Life Sciences/Pharmacy/Healthcare or equivalent, with at least five years of pharmacovigilance experience, including expertise in aggregate reports, safety signals, and Risk Management Plans. Strong communication, organizational, and negotiation skills, as well as knowledge of relevant software tools, are essential for this role. This position is based in Bangalore, India.,