POSITION SUMMARY
The VP of Drug Safety and Pharmacovigilance will provide the leadership and management for the infrastructure of the Drug Safety and Pharmacovigilance department across both clinical development and commercial products for the company. The optimal candidate participate will lead the department and also collaboratively work 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 VP of Drug Safety & Pharmacovigilance will interface with vendors, external experts, business partners, investigators, and government agencies.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Oversee the Mirum global PV system to enable compliance with global PV regulatory requirements.
Participate in 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 Mirums 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.
Participate in health authority interactions (both written and verbal) and inspections regarding safety risk management; may also oversee 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 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.
Qualifications
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 regulatory requirements for product approval and compliance in North America and Europe.
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