Senior Manager / Associate Director, Pharmacovigilance
With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.
Nuvalent is seeking a highly motivated, patient-focused, results-orientated team member for our growing Clinical organization. The Senior Manager/Associate Director, Pharmacovigilance will provide oversight and review of ICSR processing for assigned investigational products. They will ensure compliance and adherence to SOPs and manage and analyze data from the Global Safety Database. In addition, they will serve as the primary point of contact and liaison for the CRO which performs case processing activities for Nuvalent. They will work in close collaboration on safety issues with the Head of Pharmacovigilance and cross-functional team members as well as serve as a liaison to external contract safety providers and CROs.
- Serve as resource and contact for other functions within the company for pharmacovigilance operational activities.
- Perform quality review of Individual Case Safety Reports (ISCR).
- Review initial investigator causality assessment of SAE reports and source documentation for completeness, accuracy, and legibility.
- Review and edit case narrative for SAE reports and prepare MedWatch, CIOMS, and other forms, as needed.
- Apply knowledge of FDA and ICH guidelines and product labeling in performing SAE case assessments of expectedness.
- Monitor key performance indicators of case processing and present findings to Head of PV and cross-functional stakeholders.
- Review proposed queries from CRO, generate additional queries, as needed, and escalate questions/issues to Head of PV.
- Work with the CRO and Head of Pharmacovigilance to determine when cases are complete and ready to close.
- Collaborate with CRO and Regulatory team members to communicate reporting of SAEs requiring expedited submission to Regulatory Authorities and to ensure appropriate reporting is performed per timelines.
- Obtain/provided regularly scheduled listings of AEs/SAEs for safety reviews and assist in signal detection activities.
- Serve as Pharmacovigilance representative for the operational aspects of the SAE reconciliation process.
- Develops and/or reviews drug safety forms and templates in collaboration with relevant cross-functional peers .
- Assist in the development and revision of Pharmacovigilance standard operating procedure and polices.
- Assist with Safety Management Plan (SMP) development.
- Assist with inspection readiness activities and participate in audits and inspections.
- Assist with training appropriate cross-functional team members and external groups in drug safety principles and practices.
- Desire and ability to work independently and in a collaborative team setting.
- Excellent written and verbal communication skills; fluent in medical terminology.
- Working knowledge of ICH/GCP Guidelines and US CFR 314.80, 312.32; MedDRA and WHO_DRUG dictionaries.
- Ability to interpret and follow regulatory guidelines.
- Proven knowledge of Good Documentation Practices and cGXPs.
- Basic knowledge of MedDRA coding.
- Ability to multi-task and balance day-to-day drug safety operations and project work with tight timelines.
- Proficient in MS Office Suite.
- Bachelor's Degree in Nursing, RN, Pharmacy, Pharm D., or other relevant health-care related field.
- At least five years of progressive drug safety experience in a biotech/pharma company.
- Clinical Development experience.
- Experience in ICSR case-processing and reporting.
- Experience working in and with safety databases.
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