Global Pharmacovigilance Lead (announced 2 days ago)
Position Description:
The Executive Director, Global Pharmacovigilance is a member of the Global Medical Affairs (GMA) leadership team. The position plays a critical part in safeguarding the health of patients who are administered ’s product(s) through the oversight of the collecting, evaluating, reporting and collating of adverse events ensuring compliance with internal as well as external global regulatory and safety requirements. This position implements a scientifically valid early alert system to proactively discover trends and issues to provide company management with a global view of product safety. Along with Pharmacovigilance, this position will direct the design, implementation and management of applicable Risk Evaluation and Mitigation Strategies (REMS).
Primary Objectives:
• Defines the strategic Pharmacovigilance and REMS plans and policies consistent with Amarin and Global Regulatory Authorities and ensures a compliant global PV system including a PV Auditing Department and PV Compliance Department.
• Evaluates and Plans Amarin outsourcing or in-house staff strategy, in collaboration with GMA leadership team, R&D, Regulatory, and other functions, on a continuous basis to optimize Pharmacovigilance capabilities for effectiveness, efficiency, and patient focus.
• Oversee the medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event reports as well as aggregate safety reports from the spontaneous reporting system as well as from clinical and post-marketed studies.
• Provides medical evaluation of all other relevant safety information including that from clinical trials, scientific literature, and non-clinical studies for on-going surveillance and signal detection.
• Ensures compliance worldwide with applicable regulatory requirements related to Pharmacovigilance and REMS (for pharmaceutical products as well as others as appropriate).
• Design, implement and manage Risk Evaluation and Mitigation Strategies (REMS) in order to ensure that benefits outweigh potential risks for applicable products.
• Provides medical expertise on the safety profile and appropriate risk minimization measures to risk management plans.
• Accountable to work with PV service provider (external partner) for the development of processes regarding signal detection, interpretation and communication to Amarin stakeholders.
• Identifies and evaluates safety signals. Presents evaluations of potential safety signals to the global Signaling Action Committee and provides medical expertise and recommendations to the global Signaling Action Committee.
• Partners with GMA and cross functional leadership teams to ensure that Amarin Pharmacovigilance processes and tools (i.e., External PV Service Provider, databases such as ARIS Global, etc.) are kept to appropriate standards and upgraded regularly as required.
• Contributes to and provides medical pharmacovigilance review of Company Core Data Sheets, patient information leaflets and summary of product characteristics.
• Communicates effectively and efficiently on safety and benefit risk issues to internal and external groups.
• Prepares responses to regulatory agency inquiries regarding product safety, benefit-risk relations and risk management.
• Provides ongoing benefit-risk evaluation for ongoing clinical trials.
• Organizes and leads safety related audit inspections globally.
• Chairs the Amarin Safety Committee [a multi-functional group (Medical, Marketing, R&D, Reg. Affairs., Mfg, Legal, etc.)], to discuss signals from safety data collected from various channels.
• Defines and implements PV related training plans for Amarin employees and partners as appropriate
• Keeps current with laws, regulations, guidelines, etc. Identifies potential issues, policies and actions important to the Company in their formative stages and develops Company position(s) and implements appropriate.
Required Qualifications:
• MD, DO, or equivalent preferred (will also consider PharmD with extensive safety experience).
Experience:
• Minimum of 10 years’ experience in Pharmacovigilance and Risk Management in tactical, operational and strategic capacities is required.
• Previous cardiovascular or cardiometabolic / endocrinology experience is a plus.
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