Senior Medical Director, Head of Medical Safety Science

Position Summary:

Apellis Drug Safety and Pharmacovigilance is responsible for all aspects of patient safety including single case and aggregate safety monitoring, safety reporting, benefit-risk assessment, risk management planning and strategy, execution of certain post-marketing commitments, and compliance with global regulatory requirements. Key Responsibilities of the Senior Medical Director and Head of Medical Safety Science are focused on leading a team of Safety Physicians and PV Scientists, providing strategic leadership for Medical Safety Science-related activities, representing Drug Safety and PV and Medical Safety Science on cross-functional teams, and representing the Head of Drug Safety and PV as directed.

Key Responsibilities Include:

• Managing, supporting and mentoring a team of Safety Physicians and PV Scientists,
• Lead safety activities and benefit-risk strategies for products/compounds in the Company’s portfolio,
• Oversee, and support team members in the preparation, and/or review of aggregate safety review documents (such as Development/Periodic Safety Update Reports) and safety sections of relevant clinical trial documents (e.g., protocols, Investigator brochures, informed consent forms),
• Supervise the team in evaluation of signals emerging from any data source through case-series review, document analysis, safety topic reviews or other means of communication,
• Represent Drug Safety and Pharmacovigilance as the Safety Subject Matter Expert for input to regulatory product labeling and participate/provide input at labeling working group meetings, CCDS decisions and provide regional safety labeling support.
• Support the EU QPPV or other regional or local Qualified Person for Pharmacovigilance relative to issues relating to assigned products.
• Provide input to R&D publication strategy, publication plan, and ensure safety input to publications and presentations.
• Act as the global safety lead for assigned compounds in development and provide safety lead support for global submission document production and review.
• Support Safety Physicians and PV Scientists in medical safety development and execution of benefit-risk management strategies for products/compounds in the Company’s portfolio.
• Provide safety input to clinical development plans, study protocols, amendments, investigator brochure, statistical analysis plans, informed consent, clinical study reports, responses to queries from health authorities or ECs/IRBs as needed.
• Provide leadership to Safety Physicians and PV Scientists in the development of safety risk language, risk management plan, pre-submission safety activities including safety table shells, integrated safety summary documents, and safety-focused publications.
• Ensure medical safety review of development safety update reports, annual reports and other periodic safety reports.
• Actively drive safety strategy preparation for pre-NDA meetings, Advisory Committee meetings, Scientific Advice meetings, and DMC meetings.
• Provide medical safety, benefit-risk input and approve periodic safety update reports, product renewal submissions, postmarketing study documents and reports, and responses to health authority queries.
• Provide medical safety leadership, oversight of and execution of risk management strategies and RMP elements for Company’s portfolio inclusive of development of educational materials, and measures of effectiveness.
• Provide leadership and support for safety signal management (inclusive of detection, evaluation, assessment, communication). Review results of signal evaluation as directed by Head of Drug Safety and PV.
• Supervise the preparation of and review of regulatory responses.
• Provide postmarketing safety study guidance on pharmacoepidemiology topics including but not limited to investigator-initiated studies, epidemiology studies, non-interventional safety studies.
• Ensure safety labeling adequately reflects emerging postmarketing safety profile.
• Leads the Medical Safety Science team in developing and maintaining state-of-the-art pharmacovigilance processes and procedures within Drug Safety and Pharmacovigilance and R&D, including authoring of procedural documents.
• Support preparation for regulatory inspections with evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates.
• Assist the team and senior leadership in all forms of issue management and crisis management.
• Support hiring, orientation, management, mentorship, and development of staff.
• Provide input to strategic plans for safety differentiation of company products.
• Coordinate training to employees on product safety profiles/issues.
• Provide input to due diligence and potential