Senior Director, Medical Safety

Senior Director, Medical Safety

This position leads the global Medical Safety function, using analytical and report writing skills to support the safety evaluation, benefit/ risk assessment, signal detection, aggregate safety report generation and responses to regulatory authority enquiries for Pharming products. This role also contributes to the medical review of individual case safety reports and follow-up questions for Adverse Event reports and provides expert support to internal stakeholders including Clinical Operations, Medical and Regulatory Affairs on matters of patient/subject safety.

This role can be based in our Warren, NJ office (with a hybrid work schedule), but we are also open to fully remote candidates who meet the required and preferred qualifications and are able to travel to the NJ office on at least a quarterly basis in addition to the other travel required for the position.

• Responsible for the identification, evaluation, management and escalation of safety risks for Pharming products
• Manages the benefit-risk profile assessment of Pharming’s products
• Identifies, assesses, and monitors signal detection and signal management activities
• Provides responses to enquiries from Competent Authorities (e.g., EMA, MHRA, and FDA) and partners
• Ensures expertise in Risk Management Planning and reporting
• Provides medical input for aggregate reports, e.g., PSUR (PBRER) and DSUR
• Leads CCDS/CCDI updates and collaborates with Global Regulatory Affairs team on labeling updates
• Serves as a backup for Director of PV (MD) in the EU ensuring continuity of physician support
• Key member of Pharming’s safety governance bodies inc. Safety Committee
• Conducts medical reviews by making medical assessment on individual case reports including seriousness, causality, reportability etc. and contributes to medically informed follow-up queries
• Provides information requested in audits and participates in inspections
• Promotes the collection of (S)
  AEs associated with the use of Pharming’s product(s)
• Oversees the safety set-up of all new studies including the preparation of study specific SAE processing documents and Safety Management Team (SMT) activities
• Ensures the company complies with changing requirements through updating procedures and practices as appropriate
• Ensures compliance with current legal obligations and guidelines and other industry standards relating to PV by keeping up to date on changes in legislation and practices relating to PV.
• Provide leadership and coaching to direct report in the EU
• Performs other duties as assigned

• MD, DO, or equivalent medical degree required
• Minimum six years of industry experience in PV and drug safety, both for products under development as well as marketed products
• Board certification and completed residency training in a relevant clinical specialty strongly preferred
• Strong interpersonal skills with a demonstrated ability to handle conflict situations, think strategically, generate solutions to problems, and build consensus across departments internally and suppliers externally
• Highly knowledgeable in pharmacovigilance operations especially from case processing and reporting perspective
• In depth understanding of 21
  
  CFR, good pharmacovigilance practices (GVP) Modules and current drug safety/pharmacovigilance regulations
• Strong understanding of GCP/ICH guidelines
• Experience in planning, allocating and managing multiple projects
• Ability to travel domestically and internationally based on business need (estimated at 10%)
• Commitment and alignment to Pharming’s mission, core values and behaviors

We’re built on a simple belief: people living with rare diseases deserve more. Pharming is a global biotechnology company taking on some of the toughest…