Manager, Drug Safety & Pharmacovigilance
Proclinical is currently seeking a Manager of Drug Safety and Pharmacovigilance for a pharmaceutical company remotely based in San Diego, CA. Successful candidate will report to the Senior Director, Drug Safety and Pharmacovigilance. This individual will be responsible for processing case data, drafting safety narratives based on company templates, retrieving safety data outputs, producing listings from the safety database and meeting safety database standards.
- Perform data entry and processing into ARGUS platform for single case reports.
- Draft safety narratives in the ARGUS DB for MedWatch and CIOMS, utilizing company templates, guidance and standard queries.
- Collaborate with clinical development functions - Clinical Operations, Data Management, Biostatistics, Regulatory and QMS.
- Use basic Oracle safety features in the retrieval of limited data safety outputs and listings based on company processes and directions.
- Generate routine and ad-hoc safety data outputs and listings for preparation of the aggregate safety reports, such as DSUR, Investigator Brochures (IBs) and RMPs.
- Assist with relevant projects or duties as needed.
Skills and Requirements:
- BA/BS in a Life Sciences discipline required
- 3+ years of direct experience in a drug safety/pharmacovigilance environment within the pharmaceutical industry required.
- 3+ years of experience as a healthcare professional, such as nurse/registered nurse required.
- Must have direct experience and working knowledge of safety platform ORACLE ARGUS.
- Willingness to cooperate in case of emergency, as warranted.
- Maintain high personal and professional standards.
- Understand the complexity of the drug development space, while acting at the highest level of integrity and competence.
- Previous experience in oncology preferred.
- Must have verbal and written fluency in English.
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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