Senior Manager, Drug Safety and Pharmacovigilance
Seeking a Senior Manager of Drug Safety and Pharmacovigilance to ensure serious adverse event processing adheres to all global Regulatory requirements and internal SOPs, SMPs, etc. Individual will have experience in and perform multiple activities related to SAE case management, data review, document review and participating in related meetings. Successful candidate will report to Executive Director, Head of Global Safety Operations.
- Manage drug safety/PV Vendors to ensure all internal and external timelines are met.
- Maintain internal tracking documents related to clinical trial and post-marketing SAE processing.
- Responsible for collection, triage, process, review, and report of adverse event data in compliance with applicable FDA and global regulations.
- Closely monitor clinical trial and post-marketing case processing from receipt to case closure.
- Conduct complete review and assessment of all SAE reports. Prepare MedWatch, CIOMS, and other forms, as needed.
- Review and develop Drug Safety/Pharmacovigilance SOPs and Word Instructions.
- Contribute to the development of risk management plans and REMs if needed. Support safety surveillance/pharmacovigilance activities.
- Review and revise safety-related sections in study protocols, periodic reports, and Regulatory Agency submission documents.
- Review and revise SMPs, applicable SOPs and related forms.
- Assist in the preparation of safety sections for regulatory documents.
- Participate in signal detection and signal management activities.
Skills and Qualifications
- BS/MS or equivalent in a health care field or RN (coursework in clinical research preferred).
- Minimum 5 years pharmaceutical or CRO experience in a clinical research or clinical trial project management role, 3 years in a drug safety and pharmacovigilance role.
- Excellent interpersonal skills.
- Work within a matrix environment and interact/communicate effectively across various levels within the organization when needed.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Brendan Dunn at (+1) 646-481-1930 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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