Head of Pharmacovigilance Operations and Compliance

We are seeking a collaborative, proactive, and detail-oriented Manager, Pharmacovigilance Operations to lead patient safety operations across a diverse product portfolio.

This role serves as a key contributor within the Patient Safety organization and is responsible for leading day‑to‑day pharmacovigilance operations, supporting safety surveillance activities, ensuring compliance with global regulations, and maintaining inspection‑ready processes and systems. The individual will partner closely with Clinical Development, Regulatory Affairs, Medical Information, Quality, Medical Affairs, Customer Support, external vendors, and global stakeholders to support compliant and efficient safety operations.

The ideal candidate brings deep pharmacovigilance operations expertise, strong project leadership capabilities, and a passion for process excellence within a fast‑paced and evolving environment.

Leads global Patient Safety Operations and effectively manages select safety surveillance projects for multiple product categories, including prescription drugs, class I, II, and III medical devices, OTC drugs, and cosmetics.

Safety Operations

Manages communications with vendors, CROs, QPPVs, and partners regarding the evaluation, processing, and reconciliation of case reports (ICSRs, MDRs, cosmetic AE reports).

Manages communications with the clinical development team regarding safety data exchange and reconciliation between clinical and safety databases for clinical studies.

Ensures that all safety reports received by the Patient Safety group from any source are processed and reported according to ICH‑GCP guidelines, regulatory requirements and company SOPs and procedures.

Reviews all cases to ensure the accuracy, integrity and completeness of information entered in the safety database.

Ensures that expedited and non‑expedited safety reports are submitted to regulatory authorities and partner companies as required and on time.

Maintains the company electronic safety reporting portal, collates suggested inputs from cross‑functional groups, and communicates with IT to ensure appropriate implementation.

Leads PV compliance monitoring.

Maintains the company core Pharmacovigilance System Master File (PSMF). Maintains and updates PV SOPs, vendor Joint Operating Guidelines (JOGs) and relevant departmental policies.

Ensures continuous inspection and audit readiness of the Revance pharmacovigilance system by maintaining compliant processes, complete and inspection‑ready documentation, effective vendor oversight, and measurable quality and compliance metrics.

Safety Surveillance

Leads signal detection and analysis, as well as preparation and submission of signal reports.

Master's degree in Life Sciences, Pharmacology, Public Health, Nursing, or a related scientific field with 6-8+ years of pharmacovigilance experience, OR Bachelor's degree with 8+ years of relevant experience.

Progressive experience within pharmaceutical, biotechnology, or medical device environments.

End-to-end case processing and ICSR/MDR lifecycle management.

Safety databases (Argus preferred).

Signal detection and safety surveillance activities.

Pharmacovigilance compliance requirements.

Experience analyzing and interpreting safety data and assessing clinical relevance.

Demonstrated ability to manage multiple priorities and lead projects independently.

Strong cross‑functional collaboration and relationship management skills.

Completed MD, PhD, or PharmD degree with 2 or more years of clinical or academic experience and 3 or more years of patient safety experience in a pharmaceutical or medical device company.

Audit and inspection management.

Risk management plans (RMPs).

Company Core Data Sheet (CCDS) development.

Hands‑on experience with regulatory inspections, internal and external audits.

Exposure to global PV systems and multi‑region compliance.

Competitive Compensation including base salary and annual performance bonus.

Flexible PTO, holidays, and parental leave.

Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more!

All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

This section of the job description is required by the American with Disability Act (ADA). The ADA prohibits employers from discriminating against a "qualified individual with a disability" in all aspects of the employment relationship. A "qualified individual with a disability" is "an individual who meets the education, experience, skill, and other job‑related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job."

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