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Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Provides operational and strategic oversight of the U.S. pharmacovigilance system in compliance with applicable regulations (e.g., FDA, 21 CFR, ICH, EU GVP) and company standards
- Serves as Deputy LSO, assuming LSO responsibilities as required and representing the affiliate in regulatory and safety matters
- Leads ongoing safety surveillance, benefit-risk evaluation, signal detection activities, and escalation of safety issues in collaboration with Global PV and QPPV leadership
- Oversees periodic safety reporting activities (e.g., PSURs, PBRERs, DSURs), ensuring timely, complete, and accurate submissions to health authorities
- Maintains oversight of Individual Case Safety Report (ICSR) processing, reconciliation activities, and data quality monitoring
- Provides PV oversight of patient support programs, specialty pharmacy vendors, and other third-party programs, ensuring contractual and regulatory PV obligations are met
- Leads PV vendor governance, including performance monitoring, compliance with Safety Data Exchange Agreements, and issue remediation
- Drives inspection readiness strategy for the U.S. affiliate and serves as a subject matter expert during health authority inspections and audits
- Partners closely with the PV Compliance and Oversight Manager on quality issues, CAPAs, regulatory change implementation, and continuous improvement initiatives
- Represents PV in cross-functional initiatives, including product launches, regulatory submissions, and safety-related business decisions
- Provides leadership, mentoring, and performance management for PV team members; supports capability building and workforce planning
- Identifies gaps, risks, and opportunities within the local PV system and leads initiatives to strengthen compliance, efficiency, and system maturity.
Requirements
What you’ll need- Advanced degree (Master’s, PharmD, MD, or PhD) in life sciences, pharmacy, medicine, or a related discipline required
- Professional certifications in pharmacovigilance or drug safety (e.g., ISoP, DIA) preferred
- 8+ years of progressive experience in pharmacovigilance within the pharmaceutical, biotechnology, or medical device industry
- Demonstrated experience leading or co-leading local PV operations, including regulatory inspections and health authority interactions
- Hands-on experience with signal detection, safety surveillance, periodic reporting, and PV vendor oversight
- Proven people leadership experience, including mentoring and developing PV professionals
- In-depth knowledge of U.S. and global PV regulations, including FDA requirements, ICH guidelines, EU GVP modules, and GCP
- Strong scientific judgment with the ability to interpret complex safety data and make benefit-risk assessments
- Excellent leadership, organizational, and project management skills
- Strong communication and stakeholder-influencing capabilities across Medical, Regulatory, Quality, and Commercial functions
- Ability to operate effectively in a matrix organization and manage competing priorities
- Proficient with PV safety databases, signal detection tools, and quality management systems
- Fluent in written and spoken English.
Benefits
Comp & perks- Health insurance
- 401(k) plan with employer match
- Generous paid time off policy
- Hybrid work schedules
- Annual short-term incentive program
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
pharmacovigilancesignal detectionsafety surveillanceperiodic reportingdata quality monitoringbenefit-risk evaluationregulatory inspectionssafety data exchange agreementscomplianceproject management
Soft Skills
leadershipmentoringorganizational skillscommunicationstakeholder influencingstrategic oversightcollaborationproblem-solvingcapability buildingperformance management
Certifications
ISoPDIA