Associate Director, Medical Safety Science

Mirum Pharmaceuticals•Foster City, CA

2d•$210,000 - $225,000•Hybrid

About The Position

Mirum Pharmaceutical is seeking an Associate Director of Medical Safety Science. The ideal candidate will have experience performing activities related to ICSR medical review, evaluation of safety data, signal detection and validation, authoring of aggregate reports and assessment of Safety risks. The successful candidate will report to the Director of Medical Safety Science.

Requirements

MD, RN, or PharmD degree with at least 5 years of pharmaceutical or CRO experience in clinical trial and post-marketing settings in a drug safety and pharmacovigilance role.
Experience in medical review of ICSRs in clinical trial and post-marketing settings, including authoring of company comments and AOSE.
Experience in MedDRA AE and medical history coding review is required.
Working knowledge of the Safety and Clinical databases
Experience in the preparation of aggregate reports, Risk Management and Minimization programs
Experience in the preparation of safety aggregate reports
Excellent interpersonal and communication skills, both written and oral.
Understanding of medical terminology and the ability to summarize medical information is preferred.
Attention to detail and good organizational skills.
The ability to assess data and understand the medical/safety implications.
Team player but can work independently.
Excellent working knowledge of pharmacovigilance and regulatory guidelines/ guidance.
Ability to interact effectively with people of multiple disciplines and cultures both within and outside the company on a global basis

Nice To Haves

Experience in rare diseases is a plus.

Responsibilities

Conduct medical review of ICSRs from any source including, but not limited to, clinical trials, literature, and post marketing reports
Contribute to training, oversight monitoring, performance metrics review of Safety vendor activities where applicable.
Support Safety Operations activities providing input on coding for SAE reconciliation, and other case processing questions from the medical review perspective.
Generate outputs from the Safety Database for aggregate reports and ad hoc requests
Perform coding review of adverse events and medical history in the clinical database for all Mirum products and studies
Support the authoring of aggregate safety reports such as DSUR, PADER, PBRER, etc
Represent Medical Safety Science in clinical study team meetings for the assigned Mirum products
Review and develop Medical Safety Science SOPs and Work Instructions.
Contribute to the development of risk management plans and REMs as needed.
Support safety surveillance/pharmacovigilance activities such as signal detection and validation, Safety Review Team meetings (SRT), and Global Safety Committee (GSC) meetings. This includes Signal monitoring/ tracking, scheduling of SRT and GST meetings, drafting of signal detection reports.
Review medical safety science-related sections in clinical and Regulatory documents.
Review SMPs, SDEAs, applicable SOPs and related forms from a Medical Safety Science perspective.
Review and assess literature search results
Supports activities related to PV-specific audit and inspection readiness