Vice President, Drug Safety/Pharmacovigilance

1w1 week ago

Crinetics Pharmaceuticals

US · Full-time · $339,000 – $424,000

About this role

Crinetics is a pharmaceutical company developing therapies for endocrine diseases and tumors. The Vice President of Drug Safety/Pharmacovigilance will design and develop the Global Crinetics Drug Safety and Pharmacovigilance system. This role ensures adequate resourcing, efficient safety reporting, and oversight of product safety profiles.

Oversee safety reporting processes, including accurate receipt and processing of safety assessment reports. Ensure medical and causality assessments of adverse events meet company policies and regulatory requirements. Review aggregated safety reports for completeness and accuracy as required by agencies.

Provide safety support to Clinical Research and manage coordination with departments and vendors like CROs. Partner with Clinical Sciences to apply drug safety principles across development stages. Crinetics offers a patient-centric, team-oriented culture that is inclusive and dog-friendly.

This is an exciting time to join as Crinetics shapes into the world’s premier fully-integrated endocrine company. Focus on short-term and medium-term strategy, including development and implementation of strategic plans. Transform lives through rigorous innovation from discovery to patients.

Requirements

Expertise in pharmacovigilance regulations including ICH/GCP and FDA/EMA requirements
Experience in global drug safety system design and implementation
Proficiency in adverse event processing, medical assessment, and causality evaluation
Knowledge of safety surveillance and risk management plans for clinical and post-marketing phases
Ability to oversee safety content in protocols, Investigator Brochures, and regulatory submissions
Leadership in partnering with clinical teams on safety issues and white papers
Strategic planning for pre- and post-approval safety surveillance

Responsibilities

Design and develop the Global Crinetics Drug Safety and Pharmacovigilance system
Ensure adequate resourcing, efficient and compliant safety reporting
Oversee safety surveillance programs and safety profiles of Crinetics products
Lead safety risk management activities
Provide safety support to Clinical Research and oversee preparation of safety updates for regulatory submissions
Manage coordination and communication with departments and external vendors to accomplish study safety objectives
Develop and oversee safety surveillance systems for drug candidates and products
Provide coaching and mentoring to direct and indirect reports