What are the responsibilities and job description for the Director, Pharmacovigilance Safety Operations position at Alumis Inc.?
Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.
We are seeking a highly skilled and experienced Director of Safety Operations to lead and oversee the safety operation activities. This position will be pivotal in managing safety CRO, ensuring seamless and effective safety operation processes, and build safety operation systems to support regulatory filing activities.
Key Responsibilities :
- Lead and manage the drug safety operations team, providing strategic direction and oversight.
- Develop and implement drug safety policies, procedures, and systems to ensure compliance with global regulatory requirements.
- Oversee the collection, assessment, and timely submission of adverse events and safety data to regulatory authorities
- Manage safety vendor including budget, contract and resource allocations, monitor vendor performance and quality KPI
- Lead the development and maintenance of PSMF and PV QMS to support global regulatory submissions
- Lead PV inspection and audit readiness activities, act as the point of contact for regulatory inspections
- Collaborate with cross-functional teams, including clinical development, regulatory affairs, and quality assurance, to support drug safety activities for ongoing studies
Qualifications :
Skills & Competencies :
Desired Attributes :
The salary range for this position is $240,000 USD to $259,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.
This position is located in South San Francisco, CA and employees are expected to be onsite Tuesday-Thursday.
Alumis Inc. is an equal opportunity employer.
Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program.
Other benefits include :
We are a hard-working, collaborative team on a mission to transform patient’s lives and we aspire to elevate , challenge and nurture one another along the way.
Salary : $240,000 - $259,000
