Overview
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.
At Replimune, we live by our values:
United: We Collaborate for a Common Goal.
Audacious: We Are Bold.
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, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves.
Join us, as we reshape the future.
Reports to:
Sr Director, Safety Risk Management & PV Sciences
Summary of job description:
PV Scientist will report to Sr Director, Safety Risk Management & PV Sciences and support the medical component of pharmacovigilance activities including: surveillance and monitoring activities providing scientific/clinical PV expertise with a focus on the identification, evaluation and management of safety risks for Replimune developmental and marketed products. PV Scientist will collaborate closely with the safety physician and cross-functional partners to evaluate and actively manage risks in accordance with global regulatory frameworks.
Key responsibilities:
· Perform independently as well as collaboratively, all relevant safety data analyses needed for the Safety Management Team and Safety Committee meetings; ensure adequate documentation, distribution, and archiving of meeting minutes
· Create and maintain an effective signal tracking process that fully documents signaling activities and can be used for regulatory inspection
· Support other function teams for Replimune Investigational products; serve as PV expert and liaise with Clinical Operations, Biostatistics, Regulatory Affairs, Contract Research and other entities as needed
· Contribute to health authority and other safety related query responses
· Support study teams for Replimune investigational products; serve as PV expert and liaise with Clinical Operations, Medical Affairs
· Support PV Medical team for MedDRA and WHO Drug coding review and post marketing case review
· Lead post marketing case query preparation; closely work with PV compliance, PV operations and Medical Affairs
· Become familiar with ARGUS safety database reporting tool and generate line listing to support PV medical team as needed
· Demonstrate knowledge and ensure compliance with current and applicable global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH)
· Ensure compliance with Replimune and GVP&Risk Management policies and procedures
· Support PV Medical for IB update, protocol update, eCRF preparation, and ICF preparation
· Prepares aggregate safety reports (e.g.DSUR, PADER, PSUR), including project management, safety database requests, understanding and writing the content, assimilating information from other groups, and quality checks
· Plans, executes, and documents all literature surveillance activities
· Provide leadership in the development, implementation, and maintenance of robust procedures for the planning, preparation, and submission of high quality safety reports
· Contribute SOP/WI preparation/update
· Support BLA/MAA related and other PV activities such as Risk Management Plan/PV Plan creation and maintenance
· Perform other duties as directed
· Travel on site as required (e.g. site inspection, important meeting)
Qualifications:
• Pharm D, BSN, MD, PhD, MPH, advanced healthcare degree, or equivalent professional experience
• Minimum 4 years pharmacovigilance or research experience
• Thorough understanding of the drug development process and context applicable to safety surveillance activities
• Knowledge of MedDRA terminology and its application
• Knowledge of Clinical/Safety database
• Excellent written and oral…