Location: Hybrid role, 3 days a week in Waltham, MA
Some travel is required, up to 25%
Compensation: $225,000 base salary plus annual bonus and equity.
The Director of CQA-PV is the supervisor of the Clinical Quality Assurance Department with responsibilities for quality oversight of the Post Marketing Good Pharmacovigilance Practices (GPvP) and Commercial Operations that contribute to the PM PV safety data. The position is responsible for the strategy, planning, conduct, and reporting of internal and external safety audits. This position is also responsible for Pharmacovigilance inspection readiness and execution. The position will also support the quality oversight of the Prescription Drug Marketing Act (PDMA) for the company's Commercial product Sample Management. The role will also support quality oversight of safety data and related inspection readiness and execution.
Major Responsibilities:
Develop risk-based and current industry standards, annual audit planning focusing on; in-coming safety data from all sources, compliant case processing and reporting, medical review, signal detection, risk management programs, and safety related labeling
Schedule, personally conduct, and/or manage quality audits for GPvP, Commercial Safety, and PDMA activities
Build and manage internal and external resources for quality audits and ongoing departmental oversight and partnerships
Key Opinion Leader for GPvP and PDMA regulations, process strategies, and regulatory guidance (domestic & international) for all related departments
Collaborate and enhance partnerships with all departments to obtain optimal GPvP and PDMA education, training, compliance, and inspection readiness (i.e. Pre-Clinical, Clinical Development, Drug Safety, Medical Affairs, Regulatory Affairs and Commercial Operations)
Provide oversight for and participate in audits of; clinical safety and PV vendors, PV partners, electronic clinical and PV data systems, clinical and post-marketing PV documents
Qualification Requirements:
Minimum bachelor's degree in nursing, pharmacy or allied health/science
15-20 years of pharmaceutical industry experience within the Quality/Compliance Oversight of; Drug Safety, Clinical, Regulatory and/or Medical Affairs disciplines.
Preferred Experience:
Experience in global GPvP regulations, Part 11 computer systems, all types of PV internal and external auditing:
Working knowledge of US, International Conference on Harmonization (ICH) and EU GPvP, regulations and guidelines.
Knowledge of safety and sample management systems (e.g. Argus, ARISg, Trial Works, and IMPACT) as well as standard tracking databases (e.g., Track Wise).