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 communication skills, strong attention to detail, and high performance standards for quality