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: reputed company Collaborate for a Common Goal. Audacious: We Are Bold and Innovative. Dedicated: We Give Our Full Commitment. reputed company: We Are Honest With Each Other . People are at the center of everything we do, and reputed company it comes to our employees , we reputed company it personal . With a deep sense of purpose, an innovative and collaborative culture, a competitive and reputed company-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: reputed company the assessment of medical safety information including single cases and aggregate safety data for Replimune’s developmental and marketed products. reputed company 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 reputed company 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

• reputed company 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
• reputed company aggregate safety data reviews and the preparation of the medical content of periodic reports (including DSURs and PSURs) and reputed company reports
• Ensure that the safety profiles of Replimune products are accurately and consistently represented in relevant labeling documents, identify and reputed company 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 reputed company 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 reputed company Replimune products
• Participate in regular and reputed company cross functional safety review teams.
• Represent GDSRM on other multi-departmental projects
• reputed company 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 reputed company improvement initiatives as reputed company 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 reputed company-inclusive. Employees may reputed company other reputed company 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 reputed company 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 reputed company and contribute to decision-making around multifaceted issues involving medical safety.
• Excellent leadership, communication, and organizational skills
• Ability to think strategically and communicate reputed company 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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