Secura Bio was established in 2019 with a singular mission: to close the gap between innovative oncology therapies and the patients who need them most. Our high-touch approach is informed by our decades of experience shaping the impact of oncology’s largest clinical and market opportunities. We know that true impact comes from personalization and an unwavering commitment to serve patients and expand the possibilities of life-prolonging oncology medicines.

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