Biocon Hiring Drug Safety Specialist
About Company
Biocon Biologics is seeking a Drug Safety Specialist (DSS) who will possess leadership skills, excellent communication, and oversight of CRO activities. The DSS will monitor safety compliance, lead and influence stakeholders, and serve as a subject matter expert on global safety regulations and guidelines.
Position Details
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)
Location: Bengaluru
Salary: Not specified
Responsibilities
- Safety Signal Management:
- Safety signal management activities
- Periodic signal detection, signal tracking, and evaluation
- Risk Management:
- Prepares and maintains Risk Management Plans (RMP)/Risk Evaluation and Mitigation Strategies (REMS)
- Monitors effectiveness of risk minimization measures
- Responds to safety questions from regulatory authorities and partners
- Aggregate Reporting:
- Overseeing aggregate report scheduling, preparation, and submission
- Scheduling, tracking, compliance, and quality of aggregate report vendors
- Leads initiatives for process improvement in aggregate reporting
- Literature Review:
- Reviews medical and scientific literature for safety information
- Clinical Trial Support:
- Supporting clinical trial pharmacovigilance (PV) safety activities
- Compliance and SOPs:
- Prepares SOPs and working guidance ensuring pharmacovigilance compliance
- Ensures compliance and review of safety data exchange agreements
- Leadership:
- Oversees and mentors Drug Safety Specialists
- Demonstrates leadership and collaborative interaction in team environments
- Cross-functional Collaboration:
- Collaborates 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
Skills and Qualifications
- Strong organizational skills with the capability to prioritize independently with minimal supervision
- Knowledge of case processing, expedited reporting, and safety database concepts
- Proficiency in MS Office tools (Excel, PowerPoint, Word)
- Strong written and verbal communication skills
- Knowledge of biopharmaceutical industry guidelines, regulations, and best practices for pharmacovigilance