Summary of job description:

Oversee the assessment of medical safety information including single cases and aggregate safety data for Replimune’s developmental and marketed products. Lead signal detection and benefit/risk management activities and contribute to the development of pharmacovigilance strategies for monitoring the safety profile of the company’s products. Provide pharmacovigilance expertise to and lead collaborations with external partners as well as with other functions across Replimune, including Regulatory Affairs, Clinical Development, Clinical Operations, Medical Affairs, or the Commercial to ensure that drug safety communications are accurate, complete and consistent.

Key responsibilities:

• Manage the Medical Drug Safety team within the Pharmacovigilance organization. Support and supervise staff and identify system and resource needs to ensure quality and compliant medical safety evaluation processes
• Oversee risk management and benefit-risk evaluation for clinical and post marketing programs
• Provide strategic leadership to improve the consistency and accuracy of medical assessments
• Lead the development and maintenance of general safety signal management methodologies and product specific signaling strategies
• Lead aggregate safety data reviews and the preparation of the medical content of periodic reports (including DSURs and PSURs) and ad-hoc reports
• Ensure that the safety profiles of Replimune products are accurately and consistently represented in relevant labeling documents, identify and lead updates as required
• Lead the preparation and delivery of high quality, consistent, and compliant safety information for regulatory (including IND and NDA) submission documents
• Oversee the development of relevant medical sections of responses to safety related health authority requests, various clinical documents including Investigator’s Brochures, clinical protocols, safety management plans, study reports, and integrated analyses
• Organize and conduct periodic PSRC meetings to review aggregate safety information and signal management for all Replimune products
• Lead regular and ad-hoc cross functional safety review teams. Represent MSPV on other multi-departmental projects
• Oversee medical review of individual case safety reports (ICSRs)
• Educate pharmacovigilance colleagues and others as needed on medical assessment, signal detection and safety risk management practices
• Identify opportunities and manage continuous improvement initiatives as related to medical assessment of pharmacovigilance data
• Actively interact with external customers and service providers including Replimune business partners, CROs, and vendors
• Lead or contribute to the development and/or updates of relevant procedural documents including SOPs, Work Instructions, conventions, forms or templates
• Provide medical safety expertise for internal and external audits and regulatory authority inspections for Pharmacovigilance and ensure that relevant corrective actions are implemented
• Maintain an up-to-date working knowledge of applicable regulatory requirements, guidelines, and industry standards globally

Other responsibilities

This description is not intended to be all-inclusive. Employees may perform other related duties as negotiated to meet the ongoing needs of the MSPV organization.

Educational requirements:

• D. degree required

Experience and skill requirement:

• Minimum 7-10 years of relevant experience in the pharmaceutical/biotech industry in the areas of pharmacovigilance including safety signal management and benefit-risk assessment
• Minimum 2 years of experience in clinical practice or in academic medicine
• Demonstrated ability to analyze and present complex pharmacovigilance data
• Experience in global drug development including epidemiology, clinical research, medical affairs or other relevant field
• Experience authoring medical evaluations and contributing to regulatory submissions
• Strong competency in understanding the scientific background of disease mechanisms and medical therapies
• Understanding of global pharmacovigilance regulatory requirements and guidance documents
• Ability to lead and influence decision making around multifaceted issues involving medical safety
• Excellent leadership, communication and organizational skills
• Ability to think strategically and communicate complex issues clearly
• Proficiency in the use of MS Office and other relevant cloud based applications

*Please note: Candidates must be local or open to relocating as remote is not an option for some roles.  

Woburn Location: Local candidates are expected to be on-site 2 days per week. Non-local candidates open to 10-25% travel to Woburn office

Framingham Location: Please Note for Framingham roles 5 day onsite expectation

Replimune is an equal opportunity employer.

Replimune now requires COVID vaccination disclosure for all US employees.