Medical Director, Risk Management

At ProClinica, we are seeking an experienced individual to fill the role of Medical Director of Risk Management, based in Boston, MA. The successful candidate will be responsible for executing the safety and risk management activities for assigned clinical development projects or marketed products to enable the safe and effective use of products by patients and healthcare providers.

Responsibilities

• Identify issues that could be signals for observed adverse events for further review and analysis.
• Direct Safety Management Team for assigned projects/products.
• Represent GPV on other project/product team(s) or subteam(s), ensuring processes for timely collection and processing of adverse events, assessment of suspected adverse reactions, and identification of contra indications, precautions, warnings and other risk mitigations, meeting internal and external standards and timelines; and accountable for all GPV deliverables relating to the project/product.
• Collaborate with external resources such as Clinical Operations and Clinical Scientist on the identification of and resolution for potential signals.
• Detect, validate and manage pre-and/or post-approval safety signals through to resolution.
• Ensure timely, accurate recording of risk management action plans and decisions, and project ­manages GPV deliverables as appropriate to ensure completion on time to applicable standards.
• Conduct medical assessment of causality of Individual Case Safety Report (ICSR) as necessary.
• Evaluate aggregate safety data and write contributions to its interpretation for Periodic Safety Update Reports, Drug Safety Update Reports, Risk Management Plans, IB, CCSI, Safety Summaries and Clinical Overviews for the CTD, and other routine and non-routine safety and risk/benefit evaluations for internal or regulatory purposes as required.
• Provide medical interpretation of complex data to enable clinical and regulatory decision-making.
• Identify, initiate, and manage to completion, necessary updates to all relevant labeling documentation, as necessary.
• Conduct medical evaluation of issues arising from PV Operations.
• Provide medical input to ARGUS search criteria as necessary.

Skills And Qualifications

• MD and 5+ years of relevant safety and risk management experience. Rare, ultra-rare or orphan disease area experience preferred.
• Strong written, verbal, and interpersonal communication skills.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Yannick Dada at (+1) 6467418433 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.