Director of Safety Operations & Pharmacovigilance

Jasper Therapeutics•Redwood City, CA

8d•$210,000 - $230,000

About The Position

Jasper Therapeutics is a biotechnology company focused on developing new therapies to treat both chronic and life-threatening diseases. Our mission is to make safe and potentially curative therapies possible for more patients in need. We are bringing together a team of high performing biotech professionals, leading academic institutions and a strong syndicate of healthcare-focused investors to achieve our vision and deliver on our commitments. Reporting to the Chief Medical Officer, and based in our Redwood Shores offices, The Director, Safety Operations, Pharmacovigilance is responsible for implementing and coordinating the PV department procedures, providing strategic direction and oversight of operations ensuring compliance with global PV regulations. This position represents the Pharmacovigilance department internally and externally at a global level. The role supports all PV operations including but not limited to vendor selection process, vendor management, inspection readiness, KPIs and CAPAs related to PV operations, case processing metrics, SOP development and revision, and internal processes that support cross-functional PV initiatives. This role is accountable for ensuring that appropriate resources and pharmacovigilance systems and processes are in place for the evaluation and reporting of safety information, and other responses, to meet applicable global regulatory requirements for all products from development through post-marketing. This individual will provide expert guidance and decision-making and will help to shape the strategy and direction of the global function to meet the organizational needs and contribute toward the overall R&D strategy. The Director, Safety Operations, Pharmacovigilance will work closely with internal teams, will contribute to the Medical Safety and Pharmacovigilance activities, lead appropriate internal advisory committee and medical review committee discussions and decisions, and will partner with functions across Jasper to support development.

Requirements

Bachelorâs degree in scientific related field preferred or combination education/experience
10+ years of PV experience in the pharmaceutical/biotech industry
Proven track record of leadership and operational excellence.
Ability to help shape key department goals and objectives, drive process and operational efficiencies, and contribute to ongoing development of innovative best practices both internally and with other cross-functional groups.
Able to work independently, establish work priorities, and execute decisions with minimal guidance.
Experienced in global regulatory requirements for pharmacovigilance
Direct experience participating in regulatory authority inspections

Nice To Haves

Clinical trial product support and commercial product support experience preferred

Responsibilities

Lead effective vendor management strategies for PV.
Ensure PV department inspection ready.
Responsible for PV functional service provider (FSP) strategy and managing the selection process.
Responsible for developing a PV database strategy.
Provide Pharmacovigilance Operational support to clinical trial study teams and commercial products.
Serve as a subject matter expert for internal audits and global regulatory inspections.
Serves as key point of contact between PV and the CROs regarding PV operation management.
Communicates regularly with CROs and develops quality ICSR case processing and reporting metrics.
In conjunction with the compliance team, supports the escalation and investigation of safety and non-compliance issues and identifies root causes for late ICSR submissions and the implementation of appropriate corrective actions, as needed.
Develop PV training plans and competency assessments for PV department.
Contributes to the development and maintenance of Safety Management Plans (SMPs).
Provides oversight and direction to direct report(s).