Biocon Biologics Hiring: Drug Safety Specialist
About Company:
Biocon Biologics seeks a Drug Safety Specialist with leadership skills, excellent communication abilities, and oversight of CRO activities. The role involves monitoring safety compliance and leading external and internal stakeholders. The DSS serves as a subject matter expert for drug safety and collaborates with cross-functional teams and vendors on global safety regulations and guidelines.
Position Name:
Drug Safety Specialist
Organization:
Biocon Biologics
Qualification:
- Master’s degree or higher in Life Sciences, Pharmacy, or Healthcare, or equivalent qualification
- Degree in alternative Medicine, BDS, or PhD
Experience:
Minimum five years of pharmacovigilance experience (at least three years in aggregate reports, safety signal, RMP) in the pharmaceutical industry, clinical care setting, or academia
Location:
Bengaluru
Responsibilities:
- Support signal management processes including periodic signal detection, signal tracking, and evaluation
- Prepare and maintain Risk Management Plans (RMP)/Risk Evaluation and Mitigation Strategies (REMS) including risk minimization measures
- Monitor the effectiveness of risk minimization measures
- Respond to safety questions from regulatory authorities and partners
- Oversee scheduling, tracking, compliance, and quality of aggregate report vendors
- Lead initiatives for process improvement in aggregate reporting, signal management, and risk management plan preparation
- Review and provide input to safety sections of CCDS, local labels, health hazard analyses, and QA trend analyses
- Participate in pharmacovigilance audit/inspection preparation and CAPA management
- Prepare SOPs and working guidance ensuring pharmacovigilance compliance
- Oversee and mentor Drug Safety Specialists
- Ensure compliance and review of safety data exchange agreements
- Collaborate with drug safety physicians and cross-functional teams for assigned clinical studies
Additional Responsibilities:
- Device safety trend analysis
- PV Safety writing activities to support biosimilar publications
- PV training management support for BBL employees
- PV Vendor oversight
Other Responsibilities:
- Understand, interpret, analyze, and present scientific and medical data
- Knowledge of case processing, expedited reporting, and safety database concepts
- Demonstrate leadership and collaborative interaction in team environments
- Strong organizational skills with the capability to prioritize independently with minimal supervision
Qualifications:
- Master’s degree or higher in Life Sciences, Pharmacy, or Healthcare, or equivalent qualification
- Degree in alternative Medicine, BDS, or PhD
- Minimum five years of pharmacovigilance experience (at least three years in aggregate reports, safety signal, RMP) in the pharmaceutical industry, clinical care setting, or academia
- Knowledge of biopharmaceutical industry guidelines, regulations, and best practices for pharmacovigilance
- Strong written and verbal communication skills
- Proficiency in MS Office tools (Excel, PowerPoint, Word)