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Reports to: Executive Director, Risk Management & Pharmacovigilance
Location: Connecticut
Email: resume@bpsearches.com

Position Summary 

This senior leadership role in Global Pharmacovigilance and Drug Safety is accountable for the identification, communication and resolution of safety issues; delivery of persuasive argumentation about risk/benefit; and the creation of effective, efficient plans to manage risks arising in one or more assigned clinical development projects or marketed products.

The Senior Medical Director, Risk Management Lead (RML) operates autonomously generally without supervision usually within one (but sometimes in more than one) project/product teams to deliver crisp, comprehensively-considered decisions and effective strategies to address complex drug safety issues, as well as tactical follow-through to resolution. The Senior Medical Director, RML, is able to effectively navigate and influence cross-functionally to gather input, garner consensus and establish a clear path forward on a broad range of benefit-risk and safety-related topics. The impact of this position is direct and wide-ranging inside and outside the company in enabling corporate drug development and commercial goals to be met. The Senior Medical Director, RML, is recognized by seniors and peers as a Subject Matter Expert in drug safety and risk management, demonstrating broad and deep understanding of the principles, concepts, and theories of drug-induced disease, and demonstrates thought leadership within, and in external regulatory settings and/or other forums: he/she provides (rather than receives) technical, tactical, and strategic direction on GPV matters.

The scope of assessments conducted includes pharmacoepidemiological information, clinical trial data, and post-approval data from all sources, and also preclinical and CMC evidence. By incorporating his/her considered evaluation and persuasive arguments into internal and/or external influential documents, such as regulatory briefing documents, risk management plans, clinical expert reports/overviews and targeted responses to safety issues, and by developing, communicating and defending positions verbally, the Senior Medical Director, RML, leads business-impactful commercial and/or medical decision-making both within and external to the organization.

Principal Responsibilities

1. Chair a regular Safety Management Team for the assigned project(s) or product(s), setting a safety and risk/benefit driven agenda from inception to closure
2. Lead the detection, validation and management of pre- and/or post-approval safety signals through to resolution
3. Provide medical interpretation of complex PV and pharmacoepidemiological data to enable clinical and Regulatory decision-making based on up-to-date medical knowledge and scientific research
4. Create and implement timely, feasible risk management plans
5. Regarding Periodic Safety Update Reports, Drug Safety Update Reports, Risk Management Plans, IB, CCSI, Medication Guide, educational material, Safety Summaries and Clinical Overviews for the CTD, clinical study reports, briefing documents, and other routine and non-routine safety and risk/benefit evaluations for internal or Regulatory purposes as required (and required updates to these documents), related to the assigned project(s) and/or product(s) , is accountable to:
6. ensure clinical safety content is comprehensive, accurate, high quality and meets regulatory and standards
7. undertake medical evaluation and interpretation of aggregate safety data included in these documents
8. oversee the project-management of GPV deliverables to ensure completion on time
9. Medical assessment of causality of ICSRs as necessary, including the assessment of quality within the ICSR process
10. Represent GPV on project/product team(s) or subteam(s), driving efficient processes for timely collection and processing of adverse events, signal detection and management, assessment of suspected adverse reactions, and identification of contraindications, precautions, warnings and other risk mitigations, meeting internal and external standards and timelines; pre-empt or identify, and avoid or resolve, hurdles to achieving this objective; and lead the development and execution of CAPAs when necessary
11. Represent GPV at Regulatory inspections
12. Provide a Health Hazard Evaluation of a quality complaint arising in an assigned project/product
13. Medical evaluation of issues arising from PV Operations, such as use of the MedDRA dictionary and the IME list
14. Medical input to ARGUS search criteria as necessary, including development of appropriate searches where no SMQ exists
15. May represent GPV at internal strategic and/or advisory/governance committees,
16. May represent the company or act as an external technical resource, for example at DSMB or Regulatory Authority meeting or pharmaceutical industry conference

Qualifications
Extensive relevant experience (minimum 6years, 8+ preferred) in PV, safety and risk management, including signal detection, validation and management in the pharmaceutical industry, or a regulatory or academic environment.

Education 

• MD