Director, Clinical Quality Assurance, Pharmacovigilance at Alkermes, Inc. in Waltham, MA

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 Commercial product Sample Management.

The role will also support the Global Head of CQA and the CQA GLP and GCP organization regarding quality oversight of safety data and related inspection readiness and execution.

This position reports to the Global Head Executive Director of Clinical Quality Assurance and is a hybrid, onsite role at our Waltham, MA office.

Major Responsibilities:

Develop risk based and current industry standard, annual audit planning focusing on; in-coming safety data form 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’s (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
Provide management oversight for and participate in internal systems audits relevant to safety data and regulatory reporting and sample management
Provide supervisory support, mentorship and training to auditors and contract auditors
Provide quality assurance and compliance status of the company’s Pharmacovigilance and PDMA systems to management and Sr. management
Assist in vendor selection, audit qualifications, oversight and risk based auditing of 3rd parties supporting GPvP
Provide management oversight and collaborate with the Drug Safety group in follow-up to internal, vendor, specialty pharmacy and partner audits to ensure resolution of audit findings.
Assist with the maintenance of tracking systems for all GCP/GPvP audit activity, develop and present periodic metrics and risk management to company leadership
When requested provide global GPvP training
Lead the preparation and conduct of mock and regulatory agency inspections and report responses
Identify gaps in systems and processes and implement procedures as part of continuous improvement

Basic Requirements:

Requirements include minimum bachelor’s degree in nursing, pharmacy or allied health/science
15-20 years pharmaceutical industry experience within the Quality/Compliance Oversight of; Drug Safety, Clinical, Regulatory and/or Medical Affairs disciplines.

Preferred Requirements:

Must have experience in global GPvP regulations, Part 11 computer systems, all types of PV internal and external auditing:
Must have a working knowledge of US, International Conference on Harmonization (ICH) and EU GPvP, regulations and guidelines.
Must have good interpersonal skills and excellent oral and written communication skills.
Must have 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).

Travel Requirements:

20-30%

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