Senior Medical Director, Pharmacovigilance

2 weeks ago

San Diego, United States Crinetics Pharmaceuticals, Inc. Full time

Senior Medical Director, Pharmacovigilance

Categories: Pharmacovigilance

Crinetics is a pharmaceutical company based in San Diego, California that develops much-needed therapies for people with rare endocrine diseases. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and robust pipeline across preclinical and clinical development. We are driven by science with a patient-centric and team-oriented culture. This is an exciting time to join Crinetics as we shape our organization into the world's premier fully integrated endocrine company from discovery to patients. Come join our team as we transform the lives of others.

Position Summary:

The incumbent will be responsible for global pharmacovigilance for Company's investigational and/or marketed products assigned to them, including review and analysis of safety data, providing medical expertise to assigned project teams, the identification and investigation of safety signals, management of benefit-risk profile for assigned products and review of aggregate reports. Responsible for keeping upper management informed of safety issues.

This is a critical role to ensure safety of patients taking Crinetics investigational and marketed products. May be assigned work of a more complex nature or a global product that is marketed with risk management programs.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

* Maintain expert knowledge of safety, including any emerging safety concerns and risk/benefit profile for responsible compounds.
* Responsible for review of Individual Case Safety Reports (ICSRs). Ensure completeness and accuracy of safety information in ICSR through assessment of seriousness, expectedness, causality, MedDRA coding, review of narrative summary and provide case comments; provide medical inquiries for follow-up.
* Participate in individual project teams and provide medical input/expertise.
* Responsible for safety signal detection activities for assigned products and discuss safety signals as needed at Safety Review Team (SRT).
* Chair the SRT for responsible products and works effectively with all cross functional stakeholders (internal and external) to discuss and manages all new emerging safety signals from clinical trials and post marketing environment.
* Responsible for contributing and review of aggregate reports (DSUR, PSUR, RMP, ad-hoc safety reports) including but not limited to providing expert medical opinion. Draft the appropriate safety sections as well as Risk/benefit sections for aggregate safety reports.
* Support the development and execution of risk management strategies and author internal risk tracking plans and risk management/pharmacovigilance plans for submission to global health authorities for assigned products.
* Provide medical opinion and safety input to inquiries from regulatory authorities, IRBs, ethics committees, etc.
* Establishes good communication and foster relationship with cross boundary stakeholders including PV Vendors, and Crinetics Partners on all pharmacovigilance related issues.
* Responsible for the maintenance and updating of benefit-risk profile for assigned products through product lifecycle.
* Contribute and review safety sections of study reports, protocols, informed consents, Company Core Data Sheets, Investigator Brochures, clinical summary of the NDA/MAA and product labeling.
* Contribute to the strategy for NDA/MAA filing. Lead or contribute to the components of NDA/MAA dossier.
* Focus on immediate and short-term (

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