Senior Director, Global Patient Safety Science

The Senior Director, Global Patient Safety Science provides safety science and pharmacovigilance support to all products across the RevMed portfolio, which includes early and late phase development activities as a member of the Global Patient Safety team. The individual will be responsible for safety oversight and input into all aspects of study management across the portfolio.  This position may have individual reporting to it depending on the program / portfolio being led. The Senior Director of Safety Science serves as the lead for multiple or large complex strategically important developmental programs. Works closely with the other functions as part of a flexible matrix team to conduct robust safety assessments and safety risk management activities.

The Senior Director, Global Patient Safety Science will develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as an understanding of the relevant strategic context (e.g., disease under study, safety profile of competitors, mechanism of action, etc.) and is accountable for oversight of benefit/risk safety profile of allocated products through the product lifecycle.

 Specifically, you will be responsible for:

• Responsible for safety surveillance and risk management activities including, but not limited to medical review of ICSRs, routine review of safety data, and pertinent scientific literature articles. Contribute to the review of assessments for safety signals or in response to Regulatory Authority requests.

• Providing medical safety input into the design and conduct of pharmacoepidemiology and observational studies.

• Plan and interpret safety data analyses, prepare and present safety data summaries to internal and external stakeholders.

• Acquire and contribute knowledge of relevant drug class and/or competitor safety issues.

• Lead the development of safety surveillance strategy, identify potential clinical safety issues, and recommend appropriate risk mitigation measures.

• Establish and maintain collaborative working relationships with all key stakeholders (e.g., clinical study teams, safety CROs, business partners) which require expert contribution to the development of the product safety strategy.

• Accountable for risk management activities including preparation and maintenance of relevant sections of clinical trial protocols, IBs (including the reference safety information section), ICFs, DSURs, RMPs, CCDS, and labelling, as required.

• Contribute to regulatory authority submissions (Investigational New Drug applications, New Drug Applications, Marketing Authorization Applications, etc.).

• Developing response strategies in collaboration with safety committee members, providing medical-scientific input to regulatory documents for safety-related requests from health authorities and other external parties.

• Drives risk minimization strategies and takes accountability for the medical-scientific content in the Risk Management Plans, including risk minimization measures, risk minimization action plans and REMS programs, as relevant.

• Accountable for the safety components of study reports (i.e., CSRs), aggregate reports (DSUR, PSUR/PBRER, PADER) and other regulatory documents.

• Participate in internal and external Data Monitoring Committees through review of safety data, insights and leadership and development of DMC Charters.

• Lead representative for Safety Science during Health Authority meetings.

• Reviews publications, including abstracts, manuscripts, and speaker presentations.

• Trains and mentors Safety Scientists.

• Consistently comply with all governing laws, regulations, RevMed standard operating procedures (SOPs) and other guidelines.