Senior Director, Pharmacovigilance Operations – Compliance

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

📋 Description

• Develop, oversee, and manage the pharmacovigilance operations and compliance framework along with the team.

• Lead and drive the global PV Operations strategy, including planning, execution, and management.

• Provide guidance to the Head of DSPV regarding operational risks, resource distribution, and budget management.

• Take ownership of the DSPV Operations budget, which includes expenses related to CRO and vendor contracts.

• Act as a representative for DSPV Operations to senior management and external stakeholders.

• Supervise both internal and external personnel while managing the talent strategy, including hiring, development, performance management, and succession planning.

• Design and implement pharmacovigilance systems that comply with global standards.

• Manage safety systems, MedDRA updates, PV vendor oversight, quality metrics, invoicing, and budget management.

• Create and execute programs for inspection readiness, leading PV Operations during inspections and audits by the FDA, EMA, and MHRA.

• Ensure compliant case management and prompt submission of expedited safety reports.

• Develop systems for identifying, preventing, and rectifying compliance deviations and implementing Corrective and Preventive Actions (CAPAs).

• Establish safety projects, Safety Management Plans, safety systems, and configurations for PV databases.

• Draft and implement Pharmacovigilance Standard Operating Procedures (SOPs) and work instructions.

• Contribute to signal detection, benefit-risk assessments, and aggregate reporting initiatives.

• Work collaboratively with Clinical Operations, Clinical Development, Regulatory Affairs, Legal, Medical Affairs, and Manufacturing teams.

• Represent PV Operations in project teams, committees, and governance bodies.

• Lead training initiatives and ensure compliance with training requirements.

• Develop and oversee regulatory intelligence activities in pharmacovigilance.

⛳️ Requirements

• A degree in healthcare or life sciences is mandatory.

• A minimum of 15 years of experience in pharmacovigilance.

• At least 5 years in a leadership role managing global PV teams.

• Experience in both clinical and commercial lifecycle phases.

• Proven track record managing PV Operations through multiple Health Authority inspections, including those from the FDA, EMA, and MHRA.

• Experience in both clinical-stage and commercial/post-marketing settings.

• Ideally, experience across various therapeutic areas is preferred.

• Proficient in conducting process gap assessments and implementing process improvements.

• Extensive knowledge of pharmacovigilance regulations and guidelines is essential.

🏝️ Benefits

• Annual performance incentive bonus.

• Equity for new hires.

• Ongoing performance-based equity opportunities.

• Comprehensive medical insurance.

• Dental insurance coverage.

• Vision insurance plan.

• 401(k) matching program.

• Flexible time off policy.

• Paid holidays.