About the Role
We are seeking an experienced Manager of Global Drug Safety to lead comprehensive safety operations across our growing product portfolio. This role combines strategic oversight with hands-on operational excellence, serving as the primary point of contact for safety vendor operations and regulatory compliance activities. Provides clinical trial safety expertise in the product’s clinical development program. As a key contributor to our Pharmacovigilance (PV) function, you'll oversee critical safety operations including adverse event processing (post-marketing and clinical trials), regulatory reporting, and vendor management while ensuring compliance with global regulatory requirements. This position offers exceptional opportunity to shape drug safety operations in a fast-paced biotech environment where your expertise directly impacts patient safety and product development success.
Employment Type
Full Time
Reports To
Executive Director, Global Drug Safety
Key Responsibilities
- Serve as primary liaison and point of contact for vendor operations and vendor oversight, including vendors performing case management, case intake (Call Centers), and scientific literature review
- Oversee operations performed by PV vendors including contract compliance, quality and timeliness of deliverables
- Monitor Key Performance Indicators (KPIs) for PV operation vendors and ensure adherence to Service Level Agreements
- Lead change management and ongoing training while establishing vendor oversight procedures
- Provide leadership and oversight on case management to ensure adverse event information is processed according to company timelines and quality standards
- Oversee regulatory submissions for ICSRs from the Global Safety database, ensuring on-time delivery of adverse event reports to global Health Authorities and alliance partners
- Collaborate with Clinical Operations to ensure SUSAR and SAE communication to Ethics Committees and investigators as applicable
- Provide Subject Matter expertise during audits and inspections in areas of case processing, expedited reporting, and compliance
- Lead safety management support in development programs for Phase I, II, III studies
- Collaborate with Clinical Operations and PV vendors on development of safety documents for clinical trials including case report forms (eCRF), SAE collection forms, SAE reconciliation, and safety management plans
- Responsible for accuracy of safety information collection and reporting content in protocols for clinical trials and Investigator Initiated Studies
- Lead PV Operations through product life-cycle management
- Co-lead safety database migration activities including data migration planning to ensure complete, accurate and timely global safety database operations
- Liaise with PV vendors to ensure accuracy of safety database setup including maintenance and electronic reporting capabilities
- Partner with Quality Assurance, Regulatory Affairs, and Clinical Operations teams to coordinate review and approval of alliance partner safety data exchange agreements and quality agreements
- Interface with internal teams on product complaints and follow-up activities for adverse events and safety information
- Liaise with finance, contracts and PV project management for budget planning and vendor deliverable accuracy
- Coordinate clinical and project management teams to assess case volumes and ensure appropriate staffing planning at vendors
- Lead and facilitate regular joint operating committee meetings to review KPI adherence, forecast demand, and manage issue escalations
- Accountable for accuracy of safety data provided for regulatory submissions of pharmacovigilance documents such as DSURs, PSURs, and Risk Management Plans
- Accountable for the accuracy of PV operations content detailed in the, Standard Operating Procedures and Pharmacovigilance Master File and executes accordingly to maintain regulatory compliance.
Required Qualifications
- Bachelor's degree required; Advanced degree in scientific/medical or business field preferred
- Minimum 6 years pharmaceutical, healthcare, or clinical research experience with safety-related experience and relationship management required
- Experience in people management and well-developed skills in team building, motivating and developing people
- Good knowledge of PV regulations for global pre-and post-market requirements (FDA, EMA, ICH GVP) preferred
- Experience with safety databases or building/maintaining databases, including MedDRA and WHO Drug is a plus
- Understanding of medical/scientific terminology
- Demonstrated effectiveness in external partner relationship management
- Excellent written and oral communication skills with accuracy and attention to detail
- Critical thinking and analytical skills with ability to make key decisions
- Demonstrated skills in negotiation and consensus decision making
- Good cross-cultural understanding and experience
- Flexible mindset with collaborative team approach
- Ability to prioritize under pressure with well-developed organizational skills
Preferred Qualifications
- RN or Pharmacist background preferred
- Experience with vendor management and oversight in pharmacovigilance settings
- Previous biotech or pharmaceutical industry experience or research experience
- Knowledge of clinical trial safety management and regulatory submission processes