A leading pharmaceutical company is looking for a Contract Medical Writer in Pharmacovigilance to join their team based in Hertfordshire, UK.
The successful candidate will be part of the Safety documentation team and will be responsible for preparation of Safety Reports Six-Monthly SUSAR Reports and Risk Management Plans, including co-ordination, authoring and quality control.
- Co-ordinates the preparation, publication and distribution of assigned safety reports
- Authors safety reports for assigned products in accordance with departmental processes, timeframes and SOPs
- Maintains knowledge of any 3rd party requirements through liaison with Drug Safety Licensing Operations group
- Performs quality review of reports/associated documents in accordance with defined timelines:
- Completes the relevant Quality Review Checklist documenting the outcome of quality review
- Discusses quality issues with relevant personnel as required
- Ensures compliance with relevant SOPs
- Maintains drug knowledge and knowledge of the therapeutic areas for designated products
Qualifications and Experience required:
- PhD, MSc or equivalent in a biomedical discipline/qualified pharmacist, medical, nursing or healthcare experience
- Proven experience of formal report writing of a scientific/medical nature
- Experience within drug development, preferably in pharmacovigilance
- Understanding of the drug development process
- Understanding of pharmacovigilance regulatory obligations, in particular in relation to safety reports
- Previous experience in the use of a document management system (ideally Documentum) would be an advantage
- Fluent in English
- Good knowledge of medical terminology
- Computer literacy essential
For more information or to apply for this Contract Medical Writer position, please contact Krishna Pankhania at CK Clinical on 01438 870 023 or email firstname.lastname@example.org. Please quote reference CL21354 in all correspondence.