Manager / Senior Manager, Drug Safety Operations

Role Summary

Manager / Senior Manager, Drug Safety Operations. Lead and optimize operational aspects of pharmacovigilance across multiple clinical programs, oversee vendor relationships, ensure compliance with global safety regulations, and manage processes supporting patient safety and regulatory reporting. Remote work option may be available.

Responsibilities

• Vendor Oversight: Manage and oversee safety vendors responsible for case processing and related pharmacovigilance activities; ensure vendor compliance with contractual obligations, timelines, and quality standards.
• Operational Management: Oversee case processing activities, including intake, triage, and timely reporting of adverse events; maintain and monitor trackers for lab values and other safety-related data.
• Manage pharmacovigilance agreements (PVAs) with partners and ensure alignment with regulatory requirements.
• Safety Database Management: Oversee configuration, maintenance, and quality control of the safety database; ensure accurate data entry, reconciliation with clinical databases, and timely generation of safety reports.
• Cross-Functional Collaboration: Build strong relationships with internal stakeholders (clinical operations, regulatory, medical) and external partners; provide operational expertise during audits and inspections.
• Compliance & Documentation: Ensure adherence to global PV regulations (FDA, EMA, ICH) and company SOPs; manage pharmacovigilance-related quality events including change control, deviations, and CAPAs; manage PV-related KPI metrics and reporting methods.

Qualifications

• Bachelor's degree in life sciences or related field required; advanced degree preferred.
• Minimum 7+ years in drug safety/pharmacovigilance operations within biotech or pharmaceutical industry.
• Proven experience managing safety vendors and overseeing case processing activities.
• Hands-on experience with pharmacovigilance agreements and safety database management.
• Strong knowledge of global PV regulations and GVP guidelines.
• Excellent organizational, communication, and vendor management skills.
• Ability to thrive in a fast-paced, start-up environment.

Skills

• Pharmacovigilance operations
• Vendor management
• Safety database management
• Regulatory compliance (FDA, EMA, ICH)
• Case processing and safety reporting
• Cross-functional collaboration

Education

• Bachelor's degree in life sciences or related field (required); advanced degree preferred.

Additional Requirements

• Remote work available (location unspecified).