Medical Director, Pharmacovigilance

About the position Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it. We imagine a world where cancer is a curable disease. At Replimune, we live by our values: United: We Collaborate for a Common Goal. Audacious: We Are Bold and Innovative. Dedicated: We Give Our Full Commitment. Candid: We Are Honest With Each Other . People are at the center of everything we do, and when it comes to our employees , we make it personal . With a deep sense of purpose, an innovative and collaborative culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to contribute to the meaningful work we do which could impact the lives of patients . Join us, as we reshape the future. Job Summary: Perform the assessment of medical safety information including single cases and aggregate safety data for Replimune’s developmental and marketed products. Oversee 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, to ensure that drug safety communications are accurate, complete and consistent. This position can be based either in our Woburn office or be a remote role Our Woburn location welcomes hybrid work! Local candidates are expected to be on-site 2 days per week. Remote candidates (i.e., living beyond 65 miles of our Woburn HQ) must be open to 10-25% travel to our Woburn HQ , every 4-6 weeks or as business needs require . This position can be based either in our Woburn/Hybrid office or be a remote role Remote candidates (i.e., living beyond 65 miles of our Woburn HQ) must be open to 10-25% travel to our Woburn HQ, every 4-6 weeks or as business needs require.

Responsibilities

• Perform individual case safety report review, support the safety team, and identify system and resource needs to ensure quality and compliant medical safety evaluation processes
• Contribute to risk management and benefit-risk evaluation for clinical and post marketing programs
• Assure the consistency and accuracy of medical assessments
• Contribute to 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
• Contribute to the preparation and delivery of high quality, consistent, and compliant safety information for regulatory (including IND and BLA/MAA) submission documents
• Support 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 participate in periodic PSRC meetings to review aggregate safety information and signal management for all Replimune products
• Participate in regular and ad-hoc cross functional safety review teams.
• Represent GDSRM on other multi-departmental projects
• Perform 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
• 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.
• Available to address urgent requests and escalations as needed.
• 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 GDSRM organization.

Requirements

• Education: MD degree (or equivalent) required
• Required Experience: Minimum 4-6 years of relevant experience in the pharmaceutical/biotech industry in the areas of pharmacovigilance including safety signal management and benefit-risk assessment, including minimum 2 years of experience in clinical practice or in academic medicine/research environment
• 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 contribute to 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.

Benefits

• Replimune also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays including year-end shutdown.

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