Associate Director, Pharmacovigilance – PV Operations

📋 Description

• Oversee and support the relationship with safety vendors to guarantee the effectiveness, quality, and compliance of all outsourced operations.

• Provide oversight for operational safety responsibilities on behalf of the Sponsor, ensuring the timely and accurate execution of processes outlined in the relevant Safety Management plans.

• Track the performance metrics and reports of the safety vendor, as well as the quality output of the Individual Case Safety Reports (ICSRs); deliver appropriate feedback and training as necessary.

• Monitor key performance indicators for case processing and present findings to the Head of Pharmacovigilance (PV) and cross-functional stakeholders.

• Engage in daily management, operational oversight, and execution of safety tasks for assigned Nuvalent clinical programs.

• When needed, review incoming adverse event reports and communications from vendors to determine required actions and ensure prompt review, follow-up, and timely submission of expedited safety reports.

• Supervise the workflow of cases from receipt to submission between the safety vendor and the Nuvalent Pharmacovigilance team.

• Ensure that safety case inquiries are addressed according to established processes while collaborating with safety physicians, clinical operations teams, other cross-functional teams within Nuvalent, and clinical vendors, as needed, to facilitate case closure within the required timelines.

• Act as the Subject Matter Expert (SME) for pharmacovigilance operations concerning safety reporting processes as per the study protocol.

• Contribute to the development and maintenance of Standard Operating Procedures (SOPs), forms, plans, systems, and guidance documents to ensure adherence to all relevant regulatory requirements, Good Pharmacovigilance Practices (GVP), and industry best practices.

• Serve as a resource and point of contact for other company functions related to pharmacovigilance operational activities.

• Represent Pharmacovigilance regarding the operational aspects of Serious Adverse Event (SAE) reconciliation.

⛳️ Requirements

• A Bachelor’s degree in nursing, Registered Nurse (RN), Pharmacy, Doctor of Pharmacy (Pharm D.), or another relevant healthcare-related field.

• 8-10 years of experience in a biotechnology or pharmaceutical company.

• Direct experience in managing relationships with service providers or external business partners.

• Clinical Development experience.

• Strong understanding of current and evolving regulatory requirements, including EMA GVP Modules, FDA IND and NDA reporting obligations, ICH, and CIOMS.

• Capability to interpret and adhere to regulatory guidelines.

• Demonstrated knowledge of Good Documentation Practices and current Good Practices (cGXPs).

• Basic understanding of MedDRA coding.

• Experience in ICSR case processing and reporting.

• Familiarity 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.