UK - Medical Reviewer
ProClinical is advertising a vacancy for a Medical Reviewer, Global Drug Safety & Risk Management (GDSRM) position with a major biotechnology company. This organisation, which prides itself on its extensive pipeline and commercial portfolio in oncology and immunology, is broadcasting this exciting new opportunity to join their office in Stockley Park.
The Medical Reviewer, Global Drug Safety & Risk Management (GDSRM) International will report to the Director Medical Reviewer, Global Drug Safety & Risk Management. They will provide medical advice and input to the activities of AE case management as well as contributing to global pharmacovigilance and clinical trials activities. Finally, the Medical Reviewer will act as a significant point of contact between Global Drug safety and Risk Management and Trial Safety & Surveillance.
- Ensuring medical accuracy of all aspects of the Case Management groups output.
- Developing procedures in support of the Global Safety department having a significant medical context.
- Ensuring internal escalation of cases as appropriate.
- Executing the medical review of ICSRs (narrative, coding, labelling, causality, and Pharmacovigilance comments) and managing corrections (minor or major with assessment) as applicable.
- Confirming SUSARs and IND Safety Reports.
- Managing unblinding procedures from double blinded studies.
- Creating search criteria, generating reports, and preparing Analysis of Similar Events (AOSE).
- Contributing to solving reconciliation coding issues/discrepancies.
- Reviewing and updating generated follow-up letters as appropriate.
- Reviewing daily line listing of serious cases and managing corrections with Assessment as applicable.
- Communicating with Lead Safety Physicians for cases of special interest or SUSAR reports from clinical trials and generating discussions with relevant parts (Trial Safety & Surveillance) if required.
- Contributing to the resolution of issues from cases of high complexity through medical expertise and team interactions.
- Managing reviews of cases according to internal timelines.
- Supporting the evaluation of current processes and assessing alignment with regulatory expectations, guidelines, and mandates.
- Participating in product review meetings.
Skills and Requirements:
- An MD in a relevant field or international equivalent.
- Six (6) years of relevant experience, including training.
- Two (2) years pre- and post-marketing drug safety experience.
- Knowledge of medical aspects in drug safety.
- Working knowledge of MedDRA, WHO-DD is strongly preferred. Knowledge of clinical data management processes is preferred.
- Knowledge of global and EU PV regulations.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
- Mid-Senior Level.
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 contact Kevin Hansberry at +44 207 440 0636, or upload your CV 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.
€0.00 - €80000.00 per annum
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