Pharmacovigilance Scientist

Overview

Summary of job description:

PV Scientist will report to Sr Medical Director/Medical Director, Global Drug Safety & Risk Management 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.

Responsibilities

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 postmarketing case review
• Lead postmarketing 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

Qualifications

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
• Ability to analyze, interpret, and summarize complex clinical and medical literature data
• Ability to prioritize and complete work in a resourceful, self-sufficient manner while maintaining a strong mentality
• Displays ability to understand established procedures to others
• Exhibits comprehension of industry practices and regulations for drug development and pharmacovigilance
• Demonstrates awareness of related medical disciplines and an understanding of general concepts and some experiential detail within those areas
• Processes computer skills to support use of electronic systems and development of writing deliverables