Manager, Pharmacovigilance Scientist

Position Summary:

Reporting to the Head of PV Sciences, the Pharmacovigilance Scientist will be a key contributor focusing on strategic input, support in clinical trials, perform signal management activities and operational support for all Apellis products throughout the life cycle. In this new role, the successful candidate will be responsible for the oversight of PV activities, vendor and alliance management, and ongoing process improvement.

Key Responsibilities Include:

• Support product safety surveillance activities for assigned product(s) during all phases of the product life cycle.
• Provide PV support for Apellis’ developmental products in close collaboration with PV Physician and Clinical personnel.
• Lead/conducts proactive PV and risk management planning of multiple products, including preparation of the safety aspects of Global Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS) in partnership with the PV Physician and other stakeholders.
• Conduct signal detection, including adverse event data, literature, and other sources in collaboration with PV Physician and according to Apellis Signal Management and Safety Governance process.
• Perform data analysis to evaluate safety signals and write up analysis results.
• Partner with cross-functional colleagues of the Signal Management Team and contribute to safety-related deliverables associated with new drug applications, benefit-risk assessments and activities related to risk minimization including RMPs and REMS.
• Assist with developing and maintaining processes that will ensure excellence in global case reporting and assessment, demonstrating accuracy, consistency, and compliance with applicable global pharmacovigilance regulations.
• Participate in aggregate reporting, clinical trial activities, signal management, literature review, and ad hoc regulatory responses for assigned product group.
• Review and provide PV input for development of protocols, Investigator Brochures, Statistical Analysis Plans, Clinical Study Reports, and other relevant project/study documents.
• Support pharmacovigilance activities including ongoing signal management and regulatory activities.
• Facilitate cross-functional safety review meetings, including coordinating aspects of signal evaluation/safety review activities.
• Participate in writing of aggregate safety reports (e.g., DSURs, PSURs, PADERs), as required.
• Assist in the successful implementation, execution, and maintenance of safety processes and systems that conform to the company’s business strategy, industry standards and compliance with global PV regulations.
• Represent Drug Safety and PV on clinical teams and initiatives both within and across functional areas.
• Facilitate cross-functional safety review meetings, including coordinating aspects of signal evaluation/safety review activities.
• Participate in evaluation of potential safety issues in conjunction with PV Physician, Medical Monitors, and other functional areas as appropriate.
• Participate in writing of PV input for regulatory submissions and regulatory responses, collaborating with cross-functional areas as appropriate.
• Assist with writing and maintenance of Pharmacovigilance Agreements.
• Assure oversight for the review of aggregate safety data to ensure accuracy, integrity and completeness.
  
  

Education, Registration & Certification:

• Degree in Pharmacy, Nursing, Epidemiology, Biosciences (e.g., Biology) or equivalent healthcare degree with pharmaceutical industry background.

Experience:

• Minimum 2-4 years’ experience in PV.

Skills, Knowledge & Abilities:

• Excellent written and verbal communication skills with the ability to interact across multiple functions.
• Experience in the preparation and authoring of individual and aggregate safety reports.
• Knowledge of MedDRA terminology and its application.
• Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex safety information.
• Demonstrated ability to develop, execute and follow-through complex projects to completion.
• Skilled at working effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
• Independently motivated, detail oriented and strong problem-solving ability.
• Excellent organizational skills and demonstrated ability to multi-task in a fast-paced environment with changing priorities.

Physical Demands and Work Environment:

• This is largely a sedentary role; however, some