Executive Director, Drug Safety & Pharmacovigilance
Responsible for leading the Drug Safety and Pharmacovigilance department, in charge of anticipating, detecting, and analyzing product specific safety issues; ensuring proper monitoring and assessment of safety signals and determining their impact on labeling or continuation of drug development; and, for working within the assigned Asset Team(s) to set the strategy for safety activities relevant to development projects. The department is responsible for supporting products in the market and in development, ensuring continued surveillance of company products, using the most current techniques, systems and approaches, in management of safety related issues for pipeline and marketed products, in ongoing assessment of potential drug-related toxicities, and in balancing the benefit risk profile of company Purdue Pharma LP in development products. Works in close collaboration with the CSO, Heads of R&D, Heads of Regulatory, Quality, and Legal. The department works closely with the Medical Affairs organization in preparing and monitoring PMRs, and in putting together a REMS strategy for our products. Also responsible for partnering with IT to ensure the systems strategies will develop the best technical solution in conjunction in latest regulatory requirements.
Provide dynamic leadership, strategic direction and governance of patient safety and pharmacovigilance activities across Purdue Pharma and its subsidiaries’, in the context of the company’s new strategic imperatives
Ensure the development of pharmacovigilance plans / development Risk Management Plans (DRMP) for PPLP marketed / investigational products
Responsible for producing periodic reports in compliance with all regulations and guidelines within specified deadlines for each product;
In strong partnership with IT, plan and maintain “fit for purpose” Safety informatics strategies and systems, by leading efficient and effective initiatives to implement Safety tools and systems.
Manage the significant DS&P budget, including but not limited to the CRO costs, working in close cooperation with the Finance team.
Responsible for all AE case reporting including any variations in the demand and volume.
Plan and direct the deployment of safety resources to respond to needs of the business, including any surges requiring outsourcing and liaising with vendors to supply those resources.
Support CSO and Legal and quality in responses to regulatory agency ad hoc queries and comments in close collaboration with Regulatory affairs.
Advise the CSO on the medical safety strategy across all Purdue US subsidiaries for Marketed and Pipeline products.
Ensure ongoing evaluation of the overall safety profile for Purdue Pharma’s investigational products, serving as the product safety expert, working in partnership with medical monitors to bring potential safety issues to the attention of the Clinical Team and upper management.
Responsible for DS&P compliance with all regulations and guidelines for all staff; consult with Head of Operations to assign medical safety review responsibilities to Purdue employees and contractors qualified staff and CRO personnel.
Provide support for safety sections of clinical documents, including approval of the safety portion of protocols, annual reports, final study reports, IB, and other documents.
Direct signal detection surveillance activities including interpreting and reviewing possible AE signals Prepare Safety Analyses and Risk Benefit Assessments
Develop and maintain SOPs (Standard Operating Procedures) and WPDs (Working Practice Documents) related to Medical Drug Safety (DSM)
Lead, empower and develop employees, in conjunction Purdue’s values, behaviors and practices; Build strong teams, both inside the department and across the company, enabling rewarding career development and effective succession planning.
Education and Experience:
MD or Pharm D required; MD preferred.;
Minimum 10 years within pharmaceutical industry and/or clinical environment required
Minimum 5 years Drug Safety experience required
Minimum 5 years relevant management experience
Experience preferred in leading change and implementing significant reorganization initiatives (e.g. centralizing, decentralizing, M&A, divestitures etc.)
Necessary Knowledge, Skills and Abilities:
Demonstrated ability to constructively and effectively work in a highly matrixed environment, leveraging strong collaboration, relationship building and influencing skills
Thoughtfully leads through influence and maintains focus on larger priorities; delegates effectively while managing performance and holding direct reports accountable
Seasoned people leader with the ability to attract, develop and retain talent; build strong teams and plan for succession.
Excellent organizational skills including: project management, time management.
Demonstrates a sense of urgency and a passion for accomplishment
Sound problem solving skills, clarity of judgment and effective implementation of solutions.
Operates with integrity and ethics
Broad knowledge in drug development, including regulatory dossier submissions and supplemental submissions for prescription and controlled drugs in various therapeutic areas; experience in pain, CNS, addiction, and cancer an asset
Experience in epidemiology
Job Titles Supervised:
Asc Medical Director Drug Safety
Director Drug Safety Systems and Operations
Sr Mgr Alliance Management
Purdue Pharma L.P. & its Subsidiaries are an Equal Opportunity (EEO) and Affirmative Action Employer encouraging diversity in the workplace. Qualified applicants will receive consideration for employment without regard to their race, national origin, religion, age, sex, sexual orientation, marital status, gender identity, genetic information, disability, military, protected veteran status, or any other characteristic protected by local, state, or federal law. Protected veterans and qualified individuals with a disability may request a reasonable accommodation by emailing: email@example.com.
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- Pay Type Salary
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