Associate Director – Pharmacovigilance Quality Assurance

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

📋 Description

• Assist in the implementation and upkeep of a risk-based GVP-compliant quality program that encompasses clinical trial safety and post-marketing safety processes.

• Plan, execute, and/or assist with comprehensive GVP audits of service providers, business partners, affiliates, and internal pharmacovigilance processes.

• Prepare and/or evaluate audit reports and relay findings to auditees, cross-functional representatives, and management.

• Review audit responses and CAPA plans, conduct effectiveness checks, and monitor CAPAs until completion.

• Create, review, and update audit plans, SOPs, guidance documents, templates, and other relevant pharmacovigilance quality assurance documents.

• Aid in PV inspection readiness and take part in regulatory authority inspections, partner audits, and external assessments.

• Evaluate Health Authority inspection and PV partner audit reports, risks, and recommendations for communication with leadership.

• Offer PV QA guidance and training to internal stakeholders involved in clinical development, patient safety, and PV audit and inspection activities.

• Keep track of GVP regulatory intelligence and assist in the implementation of updated requirements.

• Provide quality support across Patient Safety and Pharmacovigilance, Clinical Development, Clinical Operations, Regulatory Affairs, and Medical Affairs.

• Ensure quality oversight and input for PASS-related activities, deviations, CAPAs, change controls, investigations, and other quality events.

• Deliver QA oversight for PV service providers throughout their lifecycle, including qualification, agreements, governance, and risk-based oversight.

• Assist in the development of PV QA metrics and dashboards for management oversight, trend analysis, and risk management.

• Mentor, support, and/or supervise internal and external Development QA personnel.

• Support cross-GxP QA activities that require PV expertise.

• Maintain organization, documentation, communication, and inspection readiness.

• Utilize approved company technology, including AI-enabled and digital tools, with human oversight.

⛳️ Requirements

• For Assistant Director: bachelor's degree with a minimum of 8 years, master's degree with a minimum of 6 years, or PhD with a minimum of 3 years of experience in GVP quality assurance or relevant clinical trial safety.

• For Associate Director: bachelor's degree with a minimum of 12 years, master's degree with a minimum of 8 years, or PhD with a minimum of 5 years of experience in GVP quality assurance or relevant clinical trial safety.

• Experience in the pharmaceutical and biotechnology sectors and/or service provider work experience is essential.

• A healthcare/scientific-related discipline is highly desirable.

• Strong experience in GVP auditing and clinical safety, including internal processes, business partner, and service provider audits.

• GCP auditing experience is preferred.

• Familiarity with international GVP regulations, FDA and EMA pharmacovigilance and clinical trial safety requirements, GCP regulations, health authority guidance, and ICH guidelines is necessary.

• Experience in supporting or participating in global regulatory inspections, partner audits, and inspection-readiness activities is required.

• Understanding of clinical development, risk-based quality systems, clinical pharmacovigilance, and post-market pharmacovigilance activities is important.

• Experience in writing, reviewing, and revising SOPs and controlled pharmacovigilance documents is essential.

• Oversight of PV service providers, quality agreements, CAPAs, deviations, and change controls is preferred.

• Knowledge of computer system validation and data integrity concepts relevant to GVP/GCP systems is preferred.

• Strong verbal and written communication skills with the ability to influence without direct authority are crucial.

• Excellent organizational and time management skills with the ability to handle multiple priorities are required.

• Willingness to travel, including on short notice when necessary.

🏝️ Benefits

• Comprehensive benefits package.

• Option for remote work.

• Equal Employment Opportunity employer.