Director, Clinical Quality Assurance, Pharmacovigilance

Job Description

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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About Us

Why join Team Alkermes?

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.

Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023).

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.