PV Operations Manager
Seeking a Pharmacovigilance Operations Manager to oversee the interactions with business partners including the patient support/market research program vendors and the call center. Successful candidate will assist the Head of Pharmacovigilance Operations, Head of Pharmacovigilance and Risk Management in performing additional activities as assigned.
- Integrate case-related information including medical conditions, lab results and procedures to write comprehensive SAE case narratives.
- Generate clinically relevant SAE queries to obtain missing information.
- Ensure adverse event reporting compliance with SOPs, SDEA timeframes, FDA, EMA, ICH and other regulatory requirements.
- Perform Quality Control on team members' tasks and independently prioritize workload.
- Assist with preparing and/or reviewing safety summaries for Investigator Brochures and annual reports, safety submissions for marketed products, and other safety reports as needed or requested.
- Assist in preparation of safety related sections and associated documentation for clinical and regulatory documents.
- Lead or contribute to the development and/or updates of relevant procedural documents including SOPs, Work Instructions, conventions, forms or templates.
- RN, will consider BS in pharmacy, PharmD, PA, or equivalent healthcare background; 7-10+ years of drug safety/pharmacovigilance experience.
- Experience with Argus is required.
- Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing Safety reporting and processing for clinical trial and marketed product environments.
- Working knowledge of MedDRA and WhoDrug with relevance to SAE analysis, SAE coding and concomitant medication coding.
- Proficient with Microsoft Office suite.
- Excellent written and verbal communication skills; ability to write concise, descriptive case narratives.
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 )646-481-1930or 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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