Pharmacovigilance Project Managers
RTP, NC Posted: 4/18/2022
Alphanumeric is seeking Pharmacovigilance Project Managers to work for one of the largest Pharmaceutical companies in the World. Based in the Research Triangle Park, NC (Raleigh / Durham, NC) - Remote
This is a critical role in oversight and management of the vendor involved in pharmacovigilance case processing and reporting of Consumer Healthcare (CH) Human Safety Information (HSI) to Global Health Authorities.
- Work within a global team to provide oversight of supplier delivery of PV services within a defined scope of activities aligned with specific supplier processes and deliverables.
- Maintain alignment of supplier delivery with company strategy, adhering to the third-party engagement framework and implementing third party oversight
- Supporting regulatory inspections, investigating/resolving issues and escalations and advancing methodology/process improvement initiatives.
- Ensure supplier delivery of PV services within a defined scope of accountability meet agreed upon metrics, milestones, and KPIs
- Aligns PV supplier with business strategy within respective function(s) and liaises across the PV global networks managing internal stakeholders
- Accountable to build external relationships with supplier personnel to ensure successful delivery of outsourced work
- Works across a matrix environment to drive high quality delivery of PV activities that comply with internal standards and external regulatory requirements
- Contributes to advancement of the broader CH PV business strategy and implementation of new initiatives in the functional team
- Identifies and implements performance improvement initiatives with service supplier
- Where problems or issues are identified, conducts investigation into root causes and manages corrective/preventative actions
- BSc/BA in a scientific or medically related field, plus experience in the pharmaceutical industry in pharmacovigilance, clinical development, or medical information. Equivalent work experience considered.
- In depth knowledge of GCP and GVP requirements, clinical safety documentation and reporting of adverse events with a general understanding of world-wide requirements for PV.
- Experience with Consumer Healthcare products
- Direct experience working with outsourced providers
- Excellent oral and written communication skills
- Experience with PV Case Management
- Experience in change management within Central Safety and Local Operating Companies to drive forward new initiatives
This position requires that all workers be fully vaccinated against COVID-19 and proof of vaccination will be required. Considerations will be made for those seeking Medical Exemption under ADA or Religious exemption under Title VII
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