We are seeking a Drug Safety Specialist in Safety Surveillance and Risk Management 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 medical and scientific literature for safety information
- Supporting clinical trial pharmacovigilance (PV) safety activities
The right candidate will possess leadership skills, be an excellent communicator, have oversight over CRO activities, monitor safety compliance, and successfully lead and influence external and internal stakeholders. The DSS also serves as a subject matter expert for drug safety, cross-functional teams, and vendors on relevant global safety regulations and guidelines.
Responsibilities
- Supports signal management processes including periodic signal detection, signal tracking, and evaluation
- Prepares and maintains Risk Management Plans (RMP)/Risk Evaluation and Mitigation Strategies (REMS) including risk minimization measures
- Monitors effectiveness of risk minimization measures
- Responds to safety questions from regulatory authorities and partners
- Oversees scheduling, tracking, compliance, and quality of aggregate report vendors
- Leads initiatives for process improvement in aggregate reporting, signal management, and risk management plan preparation
- Reviews and provides input to safety sections of CCDS, local labels, health hazard analyses, and QA trend analyses
- Participates in pharmacovigilance audit/inspection preparation and CAPA management
- Prepares SOPs and working guidance ensuring pharmacovigilance compliance
- Oversees and mentors Drug Safety Specialists
- Ensures compliance and review of safety data exchange agreements
- 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
Other Responsibilities
- Understands, interprets, analyzes, and presents scientific and medical data
- Knowledge of case processing, expedited reporting, and safety database concepts
- Demonstrates 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)
