Senior Vice President, Drug Safety and Pharmacovigilance

Mirum PharmaceuticalsFoster City, California, United States · Posted Today

Full-timeEst. 250,000 USD

Description

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.

POSITION SUMMARY

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

QUALIFICATIONS

Education /Experience:

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 requirements
Experience overseeing safety/PV vendors
Experience with regulatory authority inspections
Ability to provide robust safety strategies at the highest level as well as perform detailed work to support Phase 1-3 programs, as well as commercial products
Strong business acumen and ability to negotiate and collaborate with cross-functional partners to achieve department and company goals
Effective written, verbal communication and interpersonal, relationship-building skills
Proven professional track record of strategic, organizational, and executional skills to support project planning across multiple activities, with the ability to anticipate and prioritize team workload on multiple ongoing projects
Organized, attention to detail, and able to meet timelines in a fast-paced environment
Able to work with a high level of autonomy and independence
Knowledge and understanding of global regulatory requirements for product approval and compliance

#LI-HYBRID

Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran’s status or any other classification protected by applicable State/Federal/Local laws.

Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.

Mirum PharmaceuticalsFoster City, California, United States

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