Associate Director, Pharmacovigilance Operations – Compliance

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the operational lead for pharmacovigilance (PV) and represent the team throughout the clinical trial portfolio, participating in trial and safety-governance meetings to ensure adherence to PV requirements.

• Oversee the coordination of study-specific Safety Management Plans (SMPs), set up safety databases and EDC, manage SAE/SUSAR reconciliation, and facilitate study initiation and amendment processes in collaboration with CROs and cross-functional teams.

• Monitor and manage PV deliverables, timelines, and action items across all studies.

• Oversee the complete schedule and delivery of aggregate reports, which include PADERs, PBRERs, DSURs, NDA/IND Annual Reports, and APQRs.

• Assist in the timely and compliant submission of Individual Case Safety Reports (ICSRs) and periodic reports in partnership with vendors and Regulatory Affairs.

• Provide daily operational oversight of outsourced PV vendors concerning case processing, follow-up, reconciliation, signal detection, and aggregate activities.

• Manage vendor KPIs, quality metrics, and adherence to service levels; prepare for governance meetings; and ensure deviations and CAPAs are resolved promptly.

• Supervise the high-volume intake of cases to guarantee operational quality and compliance.

• Develop and maintain the PV quality framework, which encompasses SOPs, work instructions, RACI charts, process maps, training matrices, and metrics governance.

• Collaborate with Quality to uphold audit and inspection readiness, including documentation management, SOP development, and CAPA oversight.

• Facilitate compliance for drug-device combination products, including malfunction reporting obligations, PQC processing, reporting, and reconciliations.

• Ensure adherence to global GVP, FDA, and other relevant health authority regulations.

• Review and manage SOWs, change orders, and budgets for PV vendors; monitor expenses, reconcile invoices, and assist in contract negotiations.

• Conduct independent second-line reviews of PV deliverables, aggregate reports, budgets, submissions, and vendor outputs to ensure accuracy, completeness, and timeliness.

⛳️ Requirements

• Bachelor's degree in life sciences, pharmacy, or nursing; an advanced degree (PharmD, RN, MPH, MS) is a plus.

• Around 8+ years of experience in pharmacovigilance within the biotech or pharmaceutical sectors, encompassing both post-marketing and clinical trial safety.

• Proven capability to manage PV operational deliverables independently with minimal oversight.

• Robust experience in vendor/CRO oversight, aggregate report management (PADER/DSUR), and safety database operations (e.g., Argus).

• Background in supporting regulatory inspections and audits; experience with drug-device combination products is preferred.

• Comprehensive understanding of ICH guidelines, EU GVP, and US safety reporting regulations (21 CFR 314.80 and 312.32; combination-product reporting under 21 CFR Part 4 and device reporting under 21 CFR Part 803).

• Knowledge of ex-US requirements for drug-device combination products under EU MDR 2017/745.

• Proficient in using safety databases (e.g., Argus, ArisGlobal), case processing workflows, PV operational systems, and MedDRA coding.

• Strong proficiency in aggregate reporting, reconciliation, and safety documentation standards.

• Exceptional project management abilities, capable of handling multiple concurrent deliverables and deadlines.

• Excellent communication and collaboration skills across various functions and with external partners.

• Ability to represent PV effectively in cross-functional and trial governance forums.

• Keen attention to detail and a strong commitment to accuracy, with a focus on second-line quality control.

• Strong analytical and organizational skills.

• Capacity to thrive in a fast-paced environment with shifting priorities.

• High level of independence, integrity, sound judgment, and dedication to compliance.

• Occasional travel may be required (<10%).

🏝️ Benefits

• Medical insurance

• Dental insurance

• Vision insurance

• Short-term disability (STD)

• Long-term disability (LTD)

• 401(k) Savings Retirement Plan

• Employee Stock Purchase Plan (ESPP)

• Competitive compensation package

• Reasonable accommodation for qualified individuals with disabilities