ProClinical is currently seeking a Safety and Medical Information Officer for a European pharmaceutical company who is dedicated to the clinical development of new medicines for the European markets. This is an exciting opportunity for a Safety and Medical Information Officer to join a well-established and successful pharma, based in London, on a permanent basis. The Safety and Medical Information Officer will provide support for all administrative aspects of Drug Safety at MTPE such as collection, safety evaluation, reporting dissemination and filing of all case reports arising from MTPE marketed products / clinical studies, ensuring that internal and regulatory timelines are met. Responsibilities also include liaising with CRO Safety departments and MTDA and MTPC Safety departments and facilitating Global Safety review meetings (eg GST, GSC).
- Assist in Pharmacovigilance Training at MTPE. Oversee the development and maintenance of training material and documentation of training records for MTPE, Sales Force and business partners (e.g. distributors) as required.
- Maintain the Medical Information log and tracking function.
- Acknowledge and draft responses to Medical Information enquiries
- Major role in the collection, tracking, safety review, internal reporting / dissemination of all adverse events reports. Review cases for completeness, seriousness and expectedness. Ensure that all case reports undergo medical review / sign-off and forward any follow-up requests as necessary. Ensure that all documentation pertaining to all locally reported (S)AE/ADR reports are maintained in a secure location.
- Major role in the preparation and distribution of Safety Monitoring Plans for clinical projects; including the design of safety study-specific forms (i.e. SAE forms).
- Assist in the preparation and distribution of Development Safety Update Reports (DSURs) and line-listings if required, for clinical projects.
- Provide assistance in ensuring that internal and external reporting timelines are met and that worldwide regulatory authorities are notified as required by local regulations.
- Member of the Quality Standard Documents Committee (QSD).
- Increase knowledge of European regulations and guidelines regarding clinical safety / pharmacovigilance. Attend relevant safety & Medical Information courses / conferences.
- Liaise and respond to MTPC / MTPD / MTDA on issues regarding case reports and other general queries.
- Ensure compliance with Data Protection standards for medical information
- Liaise with allocated external business partners regarding safety and Medical Information reporting procedures and compliance with agreements.
- Oversee literature searching for Safety and Medical Information
- Maintain the department business partner tracker to reflect up-to-date status of Safety Agreements
- Attend with MTPE QA/Consultant to audits with a PV/Medical Information component as a Subject Matter Expert
- Attend relevant internal / external meetings which involve safety & Medical Information matters, especially in absence of manager.
- Liaise effectively and maintain professional working relationships with MTPE colleagues in all departments.
- Monitor Medical Information enquiries and direct to Medical Information Specialists for responses
- NB for 'Level of Responsibility' indicate: - 'on own initiative'; 'on approval from manager'; 'carries out task as directed'
Skills and Requirements:
- Degree educated
- At least 3 years pharmacovigilance / clinical safety experience, preferably in a global pharmaceutical company. Knowledge of Medical Information handling and systems. Experience with global safety databases and E2B reporting.
- Use of ARISg (Global Safety database), MedDRA, E2B reporting activities.
- Keen eye for detail, ability to work under pressure, good communication and organisational skills.
- Presentation skills and strong interpersonal skills required for training purposes.
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 Jon Stewart on +44 203 7520 318 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.