Executive Director, Global Head of Safety and Pharmacovigilance

Executive Director, Global Head of Drug Safety and Pharmacovigilance Position Summary
This position will report to the Chief Medical Officer and will be responsible for leading Global Drug Safety and Pharmacovigilance activities for agents under development, as well as marketed products.. The scope of the position includes oversight of Pharmacovigilance and clinical drug safety associated quality systems, safety assessments and surveillance, compliant, timely and complete regulatory authority reporting, benefit-risk assessments, risk identification and mitigation management, vendor management and oversight, and communication of safety information. The individual will be responsible for the strategy, design and further development of the existing Drug Safety and Pharmacovigilance function at Amicus. The individual will serve as the expert to internal staff across various Departments within the company (Clinical Research, Medical Affairs, Clinical Operations, Regulatory Affairs, Data Management, Statistics, Quality Assurance) leading the provision of key clinical, operational, and strategic input around safety matters, as well as knowledge of a given product's drug safety profile.
The individual will ensure effective collaboration across functions, collaborate to advance clinical development programs, deliver post-marketing commitments, oversee the safety profile of proposed independent investigator-sponsored trials, and function as the point person for pre- and post-marketing safety issues. The individual will serve as the key functional interface in inspections and audits and together with QA, in the management of any corrective action plans pertaining to PV outside of the EU. The EU QPPV will serve as such for EU inspections.
The desirable candidate should be able to oversee and manage the entirety of safety-related projects, as related to the entire research and development process, including protocol development, safety monitoring in clinical trials, preparation and finalization of clinical study reports, regulatory submissions, as well as pharmacovigilance activities for marketed products and oversight of PV and clinical drug safety associated quality systems.
Roles and Responsibilities
Lead the Global Drug Safety and Pharmacovigilance function
Have direct managerial responsibilities pertaining to the function as appropriate
Be responsible for oversight of global drug safety processes and drug safety deliverables
Build on the existing Drug Safety and Pharmacovigilance function at Amicus.
Provide detailed, accurate and timely medical review of aggregate and/or individual clinical trial and post-marketing adverse event reports (AERs)
Medically review individual case study reports from clinical trials, as well as evaluate all relevant cases in depth, including MedDRA coding
Perform regulatory assessment for expectedness and seriousness of AEs
Compose, review and deliver Periodic Adverse Drug Experience Reports
Provide SAE narrative generation; create and maintain internal SAE database; prepare and distribute investigator alerts for clinical trials
Ensure timely and appropriate drug safety contributions to NDA periodic reports
Oversee the regular review of NDA safety data with respect to safety label updates and modifications
Collaborate with Drug Development and Regulatory Affairs to develop Risk Assessment Plan for each development program, with continued monitoring throughout the development and life cycle activities for each program (as well as the compound/ agent level)
Directs the creation and maintenance of company core safety information
Review and approve safety sections of all clinical study reports (CSRs) (including interim as well as final reports)
Oversee the preparation of NDA documents, specifically the Integrated Summary of Safety (ISS) or equivalent document, and all safety related review comments or questions
Develop and oversee Risk Minimization Plan (RMP) and/or Risk Evaluation and Mitigation Strategy (REMS) for all assigned products, as pertinent
Prepare, finalize, and execute safety data exchange agreements
Oversee development, implementation and reporting of pharmacoepidemiology studies - when needed
Review and approve Investigator Brochures (IBs), IND packages, as well as NDA and IND Annual Reports
Review clinical study protocols to ensure adequacy of safety monitoring and analysis, and plans to report such safety information at the time of completion of each trial
Lead signal findings investigations and analysis
Oversee relevant quality systems
Review and revise relevant SOPs to conform to new standards
Keep informed of global new safety regulations, guidance, and policy from the relevant regulatory authorities
Oversee and track the global PV budget
M.D. degree required with at least 8-10 years of pharmaceutical Drug Safety and Pharmacovigilance experience in both the pre- and post-marketing settings, and with global experience.
Strong leadership skills, as well as experience working in a matrix environment.
Advanced ability to read, analyze and interpret safety-related scientific and medical literature
Possesses very strong writing skills and advanced verbal communication and presentation skills
Advanced ability to read, analyze and interpret clinical data and information
Requires strong attention to detail in writing and/or proofing materials, as well as in the delivery of internal and external communications
Ability to detect and recognize safety signals and conduct investigations related to safety data
Ability to work in a fast paced environment with demonstrated ability to simultaneously manage multiple competing tasks and demands
Experience and Skills
Must be experienced in safety reviews of IBs, protocols, interim and final clinical study reports, and summaries of safety, both for agents under development, as well as marketed products
Solid knowledge of general medicine and clinical practice; experience in the rare disease area is preferred.
Must have strong working knowledge of FDA and EMA regulations/ICH guidelines.
Understanding of Risk Management principles as they apply to rare disease drugs in clinical development and on the market
Proven track-record of successfully addressing challenging scenarios and comfortably working actively along-side teams on challenging assignments
Knowledge of relevant quality systems
Up to 10%

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