We are recruiting for Pharmacovigilance Scientist to join a Pharmaceutical company in Berkshire. You will be responsible for the timely processing, review, and reporting of adverse events from post-marketing sources for marketed products from the EEA, Middle East and North Africa. Experience in post-marketing reporting and doing electronic reporting is desired.
- Triages and reviews adverse events from post-marketing sources and performs follow-up on reports
- Data entry of case reports into Oracle AERS.
- Narrative production.
- Coordinates adverse event collection, medical review, and reporting of adverse events within regulatory reporting timelines.
- Electronic reporting of ICSRs to the EMA and European Competent Authorities
- Reviews literature to identify ICSRs and special situation reports.
- Participates in clinical development activities as required e.g. assist in the preparation of Safety Management Plan, SAE reconciliation plan.
- Ensures that all pharmacovigilance reporting requirements are met.
The successful candidate for this Pharmacovigilance Scientist position will enjoy the benefits of working with a global Pharmaceutical company, including a COMPETITIVE SALARY, HOLIDAYS, and CAREER PROGRESSION.
- Life sciences or nursing degree
- Knowledge of pharmacovigilance reporting procedures/requirements within the pharmaceutical industry, with proven experience.
- Experience in processing events from post-marketing sources.
- Previous use of safety databases, knowledge of Oracle AERS preferable.
- Experience of electronic reporting
- Experience of establishing electronic reporting of ICSRs to European Competent Authorities would be highly desirable.
- Excellent verbal and written communication skills.
For more information or to apply for this Pharmacovigilance Scientist position, please contact Hendre at CK Clinical on
+44 (0)1438 870 023 or email email@example.com quoting 21348 to indicate your interest.
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