Manager, Global Drug Safety & Pharmacovigilance
Asahi Kasei•Cary, NC
•Hybrid
About The Position
This position is primarily responsible for providing management level oversight, planning and execution of post-marketing and clinical trial safety activities ensuring compliance, quality, inspection readiness and operational excellence. The incumbent in this position also serves as a safety liaison with the Company’s cross-functional teams, license partners and the contract safety organizations responsible for global drug safety and pharmacovigilance.
Requirements
- Bachelor's degree in life sciences, nursing, pharmacy, or related healthcare profession with relevant experience
- At least 5 years of pharmaceutical industry drug safety and pharmacovigilance experience involving development and post-marketed products
- Solid vendor management or CRO pharmacovigilance project management experience, including safety management plan preparation, establishment of KPIs / metrics, and contract management
- Strong knowledge of ICSR processing and the adverse event lifecycle
- Solid experience with drug safety databases, especially with Argus; data migration experience preferred
- Ability to independently identify, analyze, and solve complex operational and data‑related issues
- Strong understanding of current pharmacovigilance practices and global pharmacovigilance regulations, including regulatory reporting requirements
- Self-motivated, detail-oriented, with the ability to prioritize and plan effectively
- Excellent written and verbal communication skills
- Ability to work both independently and within a matrixed team in a dynamic, fast-paced environment with shifting priorities
- Proficiency in MS Office (Word, Excel, PowerPoint, Outlook) and Adobe Pro
Nice To Haves
- data migration experience preferred
Responsibilities
- Serve as resource and contact for other functions within the company for pharmacovigilance operational activities
- Responsible for overall vendor performance and vendor service outputs (delivered timely and on budget) including, but not limited to: Oversight of US AE call center; Oversight of adverse event processing by outsourced vendor, including the review and monitoring of compliance through various monitoring reports / KPIs; Participation in quality audits of individual case safety reports (ICSR) following vendor processing, with a specific focus on accuracy of narrative to reflect source documentation, MedDRA coding, expectedness against RSIs and appropriateness of queries to seek follow-up from the clinical sites / reporter; Oversight of adverse event reconciliation between safety and clinical databases, and adverse events exchanged between licensing partners; Review of safety-related section of aggregate reports (DSUR, PSUR/PBRER, PADER, RMP); Review and approval of pharmacovigilance related documents submitted to the Trial Master File (TMF); Provision of vendor project specific training; Collaboration with vendors to develop Safety Management Plans (SMP) and relevant forms and templates; Collaboration with vendors to develop process-related documents for the purposes of improvement and standardization of new processes; and Maintaining knowledge of safety systems (Argus experience preferred)
- Assist in creating and maintaining standard operating procedures and working practices to ensure inspection readiness and compliance with regulations and guidelines
- Support internal / external audits and regulatory inspections
- Assist in management of pharmacovigilance vendor contracts and forecasting activities
- Assist in management of license partner safety data exchange agreements (SDEA)
- Assist management in establishing and coordinating all product safety operations functions in accordance with regulations and the Company’s policies and procedures
- Assist in preparation and review of regulatory submissions, such as safety reports and aggregate / periodic reports
- Represent the Company in product safety meetings with its cross-functional teams, license partners and contract safety organization
- Provide training to Company personnel and third parties for pharmacovigilance requirements and compliance
- Maintain current knowledge of regulations and regulatory guidelines, particularly in the US, Europe and Japan
Benefits
- health and insurance benefits
- training, and development opportunities
- performance-based bonus eligibility
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What This Job Offers
Job Type
Full-time
Career Level
Manager
