Vera Therapeutics, Inc. · 9 hours ago

Executive Director, PV Operations and PV Science

United States

Full-time

Remote

Director/Executive

10+ years exp

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Responsibilities

Work with Drug Safety leadership, and as per company policies and procedures for assigned Vera programs, develop and execute program-level safety strategy and implement effectively to optimize product benefit-risk profile.

Lead and oversee Medical Safety Management Teams (MSMTs) across multiple programs. Responsible for safety signal evaluation and risk management. Characterize the product’s safety risk profile in collaboration with the MSMT.

Work closely with product teams to facilitate the implementation of decisions generated from the signal evaluation process, including updates to key regulatory documents and internal/external product safety communication when necessary.

Provide expert safety review and safety content for critical submissions, including protocols, ICFs, IBs, CSRs, INDs, CTAs, and filing activities (NDA/BLA/MAAs). Respond to and resolve safety questions from regulatory authorities. Responsible for the content authoring of aggregate reports (e.g., DSUR, PBRER) when appropriate.

Support medical review of adverse event reports to ensure the accuracy, integrity, and completeness of information entered in the safety database.

Ensure oversight and maintain consistency in safety and pharmacovigilance approaches within PV operations, PV science and across studies and programs. Lead or support initiatives in developing safety processes and continuous improvement within DSPV and within any cross-functional processes that involve DSPV.

Identify trends in global safety and pharmacovigilance regulations and apply them appropriately. Build and foster strong collaborations with Vendors, external business partners and stakeholders.

Oversee development of global SOPs and policies to ensure compliance with regional PV requirements and to drive improvements in Vera global PV processes.

Ensure overall performance of the department and compliance with global regulatory requirements by implementation of appropriate SOPs, processes, key performance metrics, and monitoring of performance and compliance, and training at a global level.

Liaise with PV Vendor to ensure case processing SOPs and Tools contain guidance to allow for timely and accurate submissions to global health authorities, partners, etc.; accurate authoring of Safety Management Plans (SMPs).

Lead PV relationships with PV vendor(s) and ensure compliance with Service Level Agreements (SLAs) and Pharmacovigilance Agreements (PVAs).

Liaises with VP of DSPV for financial / project management for budget planning.

Lead case processing teams to assess / predict case volumes to ensure staffing planning at vendor.

Direct planning for ad-hoc case processing related projects eg. Ad Hoc Analysis.

Lead and facilitate regular joint operating committee meetings to review / address issues if needed.

Maintain operating procedures with vendor.

Lead change management and ongoing training; Establish and manage vendor oversight procedures and partner with Compliance and QA teams to establish and manage vendor quality agreement procedures.

Qualification

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Advanced degreePharmaceutical industry experienceGlobal Drug safetyPharmacovigilance requirementsScientific skillsClinical skillsCollaboration skills

Required

Advanced degree in health and related fields required (RN, BSN, MD, Pharm D).

10+ years of experience in the pharmaceutical industry, with a minimum of 5 years leading cross-functional safety teams in the clinical trial and post-marketing environments.

Proven track record of effective applications of Global Drug safety and pharmacovigilance requirements.

Excellent leadership skills that facilitate collaboration, problem-solving, and people growth.

Demonstrated scientific, clinical, and analytical skills to assess data and communicate effectively.