Associate Director/Director of Pharmacovigilance
ProClinical, in support of our client, are seeking an individual to fill the role of Associate Director/Director of Pharmacovigilance, based in Washington, DC. Reporting to the VP or Regulatory Affairs, the successful candidate will work in a collaborative, cross-functional environment. To oversee the implementation and coordination of safety surveillance processes and procedures for the drug safety and PV functional area.
- Create and oversee the pharmacovigilance functional area.
- File, store, and archive safety-related data.
- Prepare safety reports of adverse events (AEs) to FDA and other regulatory authorities.
- Prepare pharmacovigilance reports.
- Write or advise on safety sections of study-related documents, including protocols, investigator brochures, reference safety information, informed consent forms, clinical study reports, etc.
- Develop and review of drug safety/pharmacovigilance SOPs and work instructions.
- Contributes to the update and/or prepares the Risk Management Plans.
- Provide support to the Drug Safety Monitoring Board (DSMB) as appropriate or requested.
- Conduct safety review meetings as appropriate.
- Participate on cross-functional teams and study teleconferences.
- Collaborate with key stakeholders outside of PV.
- Represents PV/RA department in cross-functional clinical development teams; providing support to development programs and registration activities.
- Interface with medical monitor(s), safety physician, and RA to process, review, submit, track, and monitor expedited safety reports to appropriate regulatory authority within required timelines.
- Interface with medical monitors for medical assessment and regulatory classification of serious adverse events (SAEs).
- Manage and facilitate SAE reconciliation across clinical projects. SAE follow-up and case closure.
Skills And Qualifications
- Health professional or (e.g., pharmacist, MS, or PhD).
- 6+ years of pharmacovigilance or drug safety experience with a pharmaceutical/biotech PV.
- Additional experience in cell and gene therapy preferred.
- Previous experience in the development and growth of a drug safety and PV function a plus.
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 Yannick Dada at (+1) 646-741-8433 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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