Director/Senior Director Global Program Safety Physican (US/EU/IL)

Roles and Responsibilities:

• Provide strategic Patient Safety input to drug development and post-marketing programs of the given product.
• Compile safety information for clinical overviews, post-marketing safety assessment, risk management plans, labeling justifications, CCSI development and written summaries of clinical safety of common technical documents.
• Undertake and prepare high-quality evaluation documents to describe safety findings in collaboration with external vendors (when applicable).  
• Leads and reviews PV aggregate safety reports for assigned product(s) (e.g., DSUR, PBRER/PSUR), including safety database requests, working with the report's authors, and ensuring effective planning in accordance with the regulatory timelines.
• Responsible for preparation and maintenance of core safety information as used for Investigator's brochures and labeling.
• Lead the signal detection activities including safety surveillance activities, medical review and benefit-risk assessment of assigned product(s). 
• Support the development of risk management strategies for investigational     compounds.
• Address safety questions from Regulatory Authorities.
• Chair the multidisciplinary Safety Management Team whose responsibilities include safety surveillance (signal detection and evaluation), risk management planning, and making recommendations related to safety issues.
• Provide leadership to support project discussions with governance boards, including interactions with Medical Safety Review Council and leads the safety strategy for regulatory communication.   
• Provide regular updates on safety data trending, signaling and other safety related issues to the Medical Safety Review Council (MSRC) and recommend pharmacovigilance / risk management actions on behalf of the Medical Safety Team. 
• Support PV audits and inspections by participating in audit readiness activities and serving as subject matter expert during regulatory inspections.  

Qualifications:

• A Medical degree with clinical experience[KM1] [YN2]  is required.
• Must have 7+ years of profound experience in Drug Safety & Pharmacovigilance and Risk Management in pharmaceutical companies in both clinical and post-marketing. Experience in non-clinical is desirable.
• Experience in rare diseases and neurology preferred.
• Experience in signal detection with demonstrated experience in analysis, and interpretation of medical and scientific data.
• Experience in safety data analysis and writing product-related aggregate reports and safety assessments.
• Experience in the design, implementation, tracking and follow up of risk management plans.
• Experience in MedDRA coding and search strategies.
• Knowledge of regulations and guidance (EU, US and global).
• Direct experience in interacting with Health Authorities preferred.
• New product launch experience desired.

Skills:

• Ability to apply clinical judgment to interpret case information.
• Ability to synthesize large amounts of medical data and draw medical conclusions.
• Excellent interpersonal and communication skills (both written and oral) required.
• Demonstrated ability to work effectively in a cross-functional team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as independently.
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
• Strong knowledge of international regulatory requirements including ICH, European Pharmacovigilance legislation, FDA and CIOMS.
• Project management skills preferred.