Phone: (267) 948-1441
Position Overview
Our client is a commercially successful, oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers.
The Senior Medical Director, Pharmacovigilance & Risk Management is responsible for global oversight
and management of all medical safety aspects for aggregate data on product(s) during clinical
development and following marketing authorization. The incumbent directs our client safety strategy
and characterization through appropriate signal management, safety analyses and safety data
descriptions in appropriate regulatory documents for the assigned product(s). Additionally, this role
develops relevant risk management strategies for specified product-related risks. This position
collaborates cross-functionally and escalates new safety findings through the corporate safety
governance model.
Job Responsibilities
- Leads the safety strategy for all medical activities on aggregate data for assigned marketed and/or investigational product(s).
- Leads the cross-functional Safety Management Team for the assigned product(s) and escalates important safety updates to the Executive Safety Committee in a timely fashion.
- Responsible for ongoing signal detection across available data sources to further define the safety profile for assigned product(s) during clinical development and in the postmarketing setting.
- Leads the creation and updates to the Company Core Safety Information and ensures that risks are appropriately communicated in product labels for the assigned product(s).
- Provides pharmacovigilance and risk management expertise for the assigned product(s) to internal and external customers.
- Leads the safety strategy for clinical development documents and regulatory filing documents for the assigned product(s).
- Manages responses to safety questions from regulatory authorities, ethics committees, investigators and other external parties for the assigned product(s).
- Leads proactive safety data reviews and anticipates safety concerns for the assigned product(s).
- Oversees the development of safety data evaluations and summaries in the global periodic safety aggregate reports for the assigned product(s).
- Presents safety data and provides safety expertise on the assigned product(s) during key meetings (e.g. with Health Authorities, Data Safety Monitoring Boards and Investigators).
- Develops risk management strategies and monitoring plans for risk management effectiveness for the assigned product(s).
- Co-leads the benefit-risk assessment for the assigned product(s) with other functions.
- Position will have direct reports as organization scales
Job Requirements
- M.D. degree required; Board Certification (if US) preferred
- At least 3+ years of clinical experience post-residency
- At least 7-10 years of pharmacovigilance experience or other relevant experience (eg Clinical Research) in a pharmaceutical/biotechnology company.
- Pharmacovigilance experience in Oncology is a plus.
- Prior experience in a similar role in a global environment is preferred.
- Significant clinical experience (~ 10 years) may compensate for shorter experience in pharmaceutical/biotech company
- Solid knowledge and understanding of US and EU pharmacovigilance regulatory requirements and general regulatory expectations.
- Excellent clinical judgment
- Capability to synthesize and critically analyze data from multiple sources
- Ability to communicate complex critical data and analyses verbally and in writing
- Strong experience in the creation of medical content in periodic safety reports (PSUR, DSUR)
- Solid knowledge of safety risk management, signal detection and evaluation including pharmacovigilance regulatory requirements and general regulatory expectations
- Strong written and verbal communication skills
- Ability to work in intense, fast paced work environment and capacity to work under pressure
- Ability to effectively communicate in a cross-functional environment (with employees, colleagues, and global counterparts)
- Excellent teamwork and interpersonal skills are required
Location(s)
If interested, please send a MS Word version of your resume to [email protected]
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