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 align with company policies and regulatory requirements. Review completeness and accuracy of aggregated safety reports for regulatory agencies.

Provide safety support to Clinical Research and oversee preparation of safety updates for new drug applications. Partner with departments and vendors to accomplish study safety objectives. Review clinical data and ensure accountability for safety content in protocols and regulatory submissions.

Develop safety surveillance systems and lead risk management activities, including pre- and post-approval plans. Crinetics fosters a patient-centric, team-oriented, inclusive culture in a dog-friendly workplace. Join to shape the premier fully-integrated endocrine company and transform patient lives.

Requirements

Expertise in global pharmacovigilance systems and compliant safety reporting
Proficiency in medical and causality assessments for adverse events
Knowledge of ICH/GCP guidelines and regulatory safety requirements
Experience in safety surveillance and signal detection for clinical and post-marketing data
Leadership in risk management planning and special safety investigations
Ability to oversee safety content in clinical protocols and regulatory submissions
Skills in collaborating with clinical research and external vendors on safety objectives
Strategic planning for short-term and medium-term pharmacovigilance functions

Responsibilities

Design and develop the Global Crinetics Drug Safety and Pharmacovigilance system
Ensure accurate receipt and processing of safety assessment reports
Oversee preparation of new drug application safety updates and investigational new drug safety reports
Develop and oversee safety surveillance systems for drug candidates and products
Provide drug safety oversight of clinical programs including planning and execution
Lead safety risk management activities and develop surveillance plans
Review clinical data and ensure safety content in protocols and regulatory submissions
Coach and mentor direct and indirect reports while developing strategic plans