Senior Vice President, Drug Safety and Pharmacovigilance

MISSION

Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.

The SVP of Drug Safety and Pharmacovigilance will provide the leadership and management for the infrastructure and functioning of the Drug Safety and Pharmacovigilance department across both clinical development and commercial products for the company. The SVP leads the department and also works collaboratively across a team of peers in Clinical, Regulatory, Biometrics, Medical Affairs and Commercial and will be accountable for ensuring safety systems, staff and procedures are in place to support a compliant global pharmacovigilance system. The SVP of Drug Safety & Pharmacovigilance will interface with vendors, external experts, business partners, investigators, and government agencies.

JOB FUNCTIONS/RESPONSIBILITIES

• Oversee the Mirum global PV system to enable compliance with global PV regulatory requirements

• Creation of organizational strategy, goals and objectives for the department and ensure implementation of business plans to support both US and international global safety strategies

• Maintain awareness of new and emerging safety concerns and related communications to the competent authorities in a time frame appropriate to the benefit-risk assessment of Mirum’s products

• Responsible for all medical safety aspects of clinical development and post market surveillance of medicinal products in the Mirum portfolio

• Strategic oversight and overall responsibility of commercial safety reporting requirements for US, EU and other international territories, as required.

• Management, oversight and mentorship of staff able to set the strategy for future Drug Safety & PV department build and planning

• Partner with clinical development representatives to lead safety signal assessments and validate safety signals

• Communicate important safety information to appropriate stakeholders, including executive management, as appropriate

• Participate in health authority interactions (both written and verbal) and inspections regarding safety risk management; oversees team members who support such interactions

• Oversight of Drug Safety Committees & Core Safety Information

• Contribute written summaries and provide safety review for safety components of protocols, IB, clinical study reports, regulatory submissions, label negotiations etc. by working directly with team members and offering strategic and tactical support when needed

• Oversee, Write or Review of periodic aggregate/safety reports

• Perform Benefit-Risk Assessments in collaboration with Clinical Development, as required

• Ensure compliance with global safety requirements and inspection readiness, including root-cause analyses

• Manage relationships with clients and team members providing expert safety knowledge

• Support the evaluation of business opportunities, as directed by executive management

• MD, PharmD or equivalent degree

• Minimum of fifteen (15+) years Pharmacovigilance experience with at least five (5) years of department management experience

• Experience in building teams, directly or matrixed and leading projects

• Experience in risk management strategies and signal detection strategies

• Robust knowledge of global PV