Senior Vice President, Pharmacovigilance

2 weeks ago

Foster City, California, United States Mirum Pharmaceuticals Full time

POSITION SUMMARY


The Senior Vice President of Pharmacovigilance will spearhead the leadership and management of the Drug Safety and Pharmacovigilance division, ensuring robust infrastructure across both clinical development and commercial products for Mirum Pharmaceuticals.

The ideal candidate will not only lead the department but also collaborate effectively with peers in Clinical, Regulatory, Biometrics, Medical Affairs, and Commercial sectors. This role is pivotal in guaranteeing that safety systems, personnel, and procedures are established to uphold a compliant global pharmacovigilance framework.

The Senior Vice President will engage with vendors, external experts, business partners, investigators, and regulatory bodies.

ESSENTIAL DUTIES AND RESPONSIBILITIES
Supervise the Mirum global pharmacovigilance system to ensure adherence to international regulatory standards.


Contribute to the formulation of strategic objectives and goals for the department, ensuring the execution of business plans that align with both US and international safety strategies.


Stay informed about emerging safety issues and communicate relevant information to the appropriate authorities in a timely manner, aligned with the benefit-risk evaluation of Mirum's products.


Oversee all medical safety aspects related to clinical development and post-market surveillance of medicinal products within the Mirum portfolio.

Provide strategic oversight and comprehensive responsibility for commercial safety reporting obligations across the US, EU, and other international regions, as necessary.


Manage, guide, and mentor staff to establish a forward-looking strategy for the Drug Safety and Pharmacovigilance department's growth and planning.

Collaborate with clinical development teams to lead safety signal evaluations and confirm safety signals.


Engage in interactions with health authorities (both written and verbal) and inspections regarding safety risk management; may also supervise team members involved in these interactions.

Oversee Drug Safety Committees and Core Safety Information.


Draft written summaries and conduct safety reviews for safety-related components of protocols, Investigator's Brochures, clinical study reports, regulatory submissions, label negotiations, etc., by working closely with team members and providing tactical support as needed.



Supervise, author, or review periodic aggregate/safety reports.

Conduct Benefit-Risk Assessments in collaboration with Clinical Development, as required.

Ensure compliance with global safety standards and readiness for inspections, including conducting root-cause analyses.

Manage relationships with clients and team members, offering expert safety insights.

Qualifications

MD, PharmD, or equivalent degree.

A minimum of fifteen (15+) years of experience in Pharmacovigilance, including at least five (5) years in a management role.

Proven experience in team building, whether directly or through a matrix structure, and leading projects.

Demonstrated expertise in risk management and signal detection strategies.

Comprehensive knowledge of global pharmacovigilance requirements.

Experience in overseeing safety/pharmacovigilance vendors.

Familiarity with regulatory authority inspections.


Ability to devise comprehensive safety strategies at a high level while also performing detailed work to support Phase 1-3 programs and commercial products.

Strong business acumen and the ability to negotiate and collaborate with cross-functional partners to achieve departmental and organizational objectives.

Exceptional written and verbal communication skills, along with strong interpersonal and relationship-building capabilities.


A proven track record of strategic, organizational, and executional skills to facilitate project planning across multiple initiatives, with the capacity to anticipate and prioritize team workload across various ongoing projects.

Highly organized, detail-oriented, and capable of meeting deadlines in a dynamic environment.

Able to operate with a significant degree of autonomy and independence.

Thorough understanding of regulatory requirements for product approval and compliance in North America and Europe.

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