Associate Director, Pharmacovigilance – PV Operations
Job Description:
- Manage and support the relationship with safety vendor(s) to ensure effectiveness, quality and compliance of all outsourced activities.
- Provide Sponsor oversight of operational safety responsibilities, including the timely and accurate execution of the processes defined within the applicable Safety Management plans.
- Monitor performance (metrics, other reports) of the safety vendor and the quality output of the ICSRs; provide appropriate feedback and training.
- Monitor key performance indicators of case processing and present findings to Head of PV and cross-functional stakeholders.
- Participate in daily management, operational oversight and execution of operational safety tasks for assigned Nuvalent clinical programs.
- As needed. review incoming adverse event reports and communications from vendors to determine action required and ensure prompt review, follow-up, and timely submission of expedited safety reports.
- Oversee case workflow (case receipt through submission) between safety vendor and Nuvalent Pharmacovigilance team.
- Ensure safety case queries are resolved as per defined processes (interfacing with safety physicians, clinical operations team, other cross-functional teams within Nuvalent, and clinical vendors, as required) and facilitate case closure within required timelines.
- Serve as PV operations SME on safety reporting processes according to study protocol.
- Participate in the development and maintenance of SOPs, forms, plans, systems, and guidance documents to ensure compliance with all applicable regulatory requirements or guidelines, GVP and industry best practices.
- Serve as resource and contact for other functions within the company for pharmacovigilance operational activities.
- Serve as Pharmacovigilance representative for the operational aspects of the SAE reconciliation.
Requirements:
- Bachelor’s degree in nursing, RN, Pharmacy, Pharm D., or other relevant health-care related field.
- 8-10 years of experience in a biotech/pharma company.
- Direct experience managing relationships with service providers or external business partners
- Clinical Development experience.
- Strong knowledge of current and emerging regulatory requirements including EMA GVP Modules, FDA IND and NDA reporting requirements, ICH, CIOMS
- Ability to interpret and follow regulatory guidelines.
- Proven knowledge of Good Documentation Practices and cGXPs.
- Basic knowledge of MedDRA coding.
- Experience in ICSR case-processing and reporting.
- Experience working in and with safety databases.
Benefits:
- medical, dental, and vision insurance
- 401(k) retirement savings plan
- generous paid time off (including a summer and winter company shutdown)
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