Drug Safety and Pharmacovigilance Scientist

At Proclinical, we are seeking a talented and experienced individual to fill the role of Drug Safety and Pharmacovigilance Scientist, based remotely. Reporting to the Senior Director of Drug Safety and Pharmacovigilance, the successful candidate 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.

Responsibilities

• Perform data entry and processing into ARGUS platform for single case reports (ICSR).
• 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.

Skills And Qualifications

• 3-5 years of direct drug safety/PV experience within the pharmaceutical industry, and 3-5 years' experience as a healthcare professional (RN, etc.)
• Direct experience and working knowledge of safety platform ORACLE ARGUS.
• Previous experience in oncology preferred
• Strong written, verbal, and interpersonal communication skills, including English fluency.

To Apply:

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 Brandon Zheng at (+1) 646-851-0869 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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