Senior Director, Pharmacovigilance Operations

Senior Director, Pharmacovigilance Operations page is loaded## Senior Director, Pharmacovigilance Operations remote type:
Remote locations:
Remote time type:
Full time posted on:
Posted 2 Days Agojob requisition :
JR000548

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. 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 a robust preclinical and clinical development pipeline.

We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. 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. Join our team as we transform the lives of others.
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* Position Summary:

** The incumbent will provide oversight for the Pharmacovigilance (PV) Operations elements of the pharmacovigilance function. This includes overall accountability for vendor management/oversight; training; business integration;
Quality Management System (QMS);
Safety Data Exchange Agreements (SDEAs); PV Safety database; and Budgets. This position will also lead, and actively contribute to, the development or revision of existing PV processes related, but which may not be limited to:
Quality, standards, and training. The incumbent works cross-functionally with internal departments/key stakeholders and external resources on pharmacovigilance-related matters.
** Essential Job Functions and Responsibilities:
** These may include but are not limited to:
* Provide oversight for work performed by pharmacovigilance vendor(s) including compliance, KPI, etc.
* Participate in process improvements and vendor-client Safety Management Plans and timelines for processing and reporting safety data from clinical trials and post marketing surveillance.
* Accountable for business integration including safety data migration and integrating new assets or companies into Crinetics PV system.
* Accountable for development or revision of SOPs, work instructions, guidance in regard to all functions within PV.
* Participate in investigator meetings as needed to train investigators and qualified site personnel in the collection and reporting of SAEs to study sponsor; receive clinical study SAE reports, review for medical/regulatory content and assure accuracy per protocol requirements; interface with medical monitors for medical assessment and regulatory classification of SAEs; manage and facilitate SAE reconciliation across projects to ensure compliance with objectives and goals, adverse event follow-up and case closure.
* Accountable for Quality Management System within PV including compliance, best practices, and continuous process improvements.
* Accountable for working with relevant internal departments, and actively contributing to, the development of the PSMF.
* Work closely and collaborate with EU and local Qualified Person (QP) to develop new or maintain pharmacovigilance processes supporting both development and marketed/commercial products.
* Develop SDEAs or pharmacovigilance agreement with Crinetics partners and vendors for specific obligations for safety data exchange and reporting.
* Build relationships and collaborate with Clinical Development and Clinical Operations to improve process for safety reporting, reconciliation of safety data and protocol template development.
* Build relationships, and collaborate with, Regulatory Affairs Operations to improve process for safety reporting to global Health Authorities (HA).
* Contribute to inspection readiness and lead HA inspections of Crinetics’ pharmacovigilance function.
* Responsible for PV budgets, MSA and SOW with PV vendors.
* May manage, coach and mentor direct reports.
* Performs other tasks and assignments as needed.
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* Education and Experience:

*** Bachelor’s degree in healthcare…