MBBS Jobs at Biocon Biologics: Drug Safety Specialist – Apply Now
Discover how Biocon Biologics is revolutionizing healthcare by championing affordable biosimilars and innovative drug safety practices. Learn about the exciting opportunity for a Drug Safety Specialist to contribute to a global mission focused on patient-centric care and regulatory excellence.
Job Posting: Drug Safety Specialist
Location: Bengaluru, Karnataka, India
At Biocon Biologics, we are seeking a drug safety specialist in Safety Surveillance and Risk Management who is responsible for safety signal management activities, risk management plans & overseeing aggregate report scheduling, preparation, and submission, responding to safety questions from internal and external stakeholders, reviewing the medical and scientific literature for safety information and supporting clinical trial PV safety activities. The right candidate will have leadership skills, be an excellent communicator with an ability to have oversight over CRO activities, monitor safety compliance and can successfully lead and influence external and internal stakeholders. DSS also serves as a subject matter expert for drug safety, cross-functional teams and vendors on relevant global safety regulations and guidelines and data output and analyses.
Responsibilities:
- Supports the signal management process: Set up process for periodic signal detection, review meetings, signal detection overview reports, etc.
- Prepares and maintains the Risk Management Plans: Including risk minimization measures and monitoring effectiveness.
- Supports the process for responding to safety questions: From regulatory authorities and partners.
- Collaborates with aggregate report vendors: Oversees scheduling, tracking, compliance, and quality.
- Contributes to process improvement and consistency: Regarding aggregate reporting, signal management, etc.
Additional Responsibilities:
- Device safety trend analysis
- PV Safety writing activities to support biosimilar publications
- Training Management Support- PV trainings for BBL employees
- PV Vendor Oversight
Qualifications:
- Master’s degree or higher within Life sciences/Pharmacy/Healthcare Degree in alternative Medicine / BDS / PhD
- At least five years of pharmacovigilance experience: Minimum 3 years in aggregate reports, safety signal, RMP, etc.
- Knowledge of the biopharmaceutical industry: Understanding of guidelines, regulations, and best practices for pharmacovigilance activities.
- Good written and verbal communication skills, strong interpersonal skills, attention to detail
- Knowledge of common data processing software: MS Office tools (Excel, Power Point, Microsoft Word, etc)
Job Location: Bangalore, India
