Oversee all safety reporting activities managed by CROs and consultants, including expedited reporting (SAEs, SUSARs) and periodic aggregate safety reports (DSURs, PSURs/PBRERs).
Serve as the primary point of contact for CRO pharmacovigilance teams, ensuring clear communication, accountability, and delivery of safety obligations.
Develop, negotiate, and manage PV sections of contracts, safety management plans, and operational agreements with CROs and consultants.
Monitor CRO performance through KPIs, audits, and oversight activities, ensuring timely and accurate reporting to regulatory authorities, ethics committees, and investigators.
Collaborate with internal stakeholders (Clinical Development, Regulatory Affairs, Quality, Legal) to ensure alignment on PV strategy and compliance.
Provide oversight for case processing, medical review, and data reconciliation activities performed by CROs and consultants.
Ensure compliance with global regulations (FDA, EMA, MHRA, ICH, GVP, etc.) and maintain inspection readiness.
Support development and maintenance of internal PV policies, SOPs, and training programs.
Participate in safety signal detection activities and safety governance committees, as needed.
Oversee maintenance and compliance of an externally hosted electronic safety database for tracking, storing, and reporting of serious adverse events.
Participate in regulatory inspections and PV audits to ensure quality, integrity, and compliance with pharmacovigilance and safety reporting requirements per SOPs and global regulations.

Requirements

Master’s degree or higher in a healthcare field.
10 or more years of pharmacovigilance experience, including at least 5 years in a leadership or oversight role.
Strong experience managing CRO/vendor relationships, particularly in clinical trial safety reporting, including governance oversight.
Deep knowledge of global pharmacovigilance regulations, GVP, ICH guidelines, and relevant reporting requirements.
Experience with oversight of drug safety databases (e.g., Oracle Argus).
Proven track record of ensuring compliance in a global PV environment.

Benefits

an annual target bonus
equity
a comprehensive suite of competitive benefits designed to support our employees’ overall well-being

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

pharmacovigilancesafety reportingcase processingmedical reviewdata reconciliationsafety signal detectioncontract managementKPI monitoringaudit oversightcompliance management

Soft skills

communicationaccountabilitycollaborationleadershipnegotiationorganizational skillsoversightproblem-solvingstrategic alignmenttraining development

Certifications

Master’s degree in healthcarepharmacovigilance certification