ID-Clinical - personnel resourcing specialists for the Pharmaceutical, Biotechnology and Clinical Research industry.

ID-Clinical Candidates Job - Pharmacovigilance Medical Writer

Reference IDSS400103DP
Title Pharmacovigilance Medical Writer
Description To support the monitoring of the safety of the Company's products through the accurate preparation of quality reports required by internal and external customers to pre-specified timelines.

To undertake medical writing projects within pharmacovigilance such as Periodic Safety Update Reports, IND updates and Annual Safety Reports, responses to questions from regulatory authorities, Company Core Safety Information supportive packages or other documents as required.

To ensure that pharmacovigilance medical writing deliverables meet regulatory and internal specifications, and that they are produced to defined standards as regards to quality.

To provide pharmacovigilance input relating to the writing of pharmacovigilance documents to project teams.

To plan, schedule and track pharmacovigilance medical writing activities to ensure high quality, timely and accurate completion of deliverables.

To develop or provide comments on Standard Operating Procedures (SOPs) and templates used for the production of pharmacovigilance regulatory and internal reports and documents.

To file all produced documents in accordance with SOPs.

To consolidate pharmacovigilance documents within the EDMS document management system or post them on the intranet as required.

To perform any other activity as may reasonable be required from time to time.

To complete all the above activities within the framework and in compliance with ICH Guidelines, Company SOPs and other documentation in force within the Group.

Medical Sciences Degree (Biology, Pharmacology, Pharmacy, Chemistry)
Ability to present information in a clear, accurate, logical and non-technical manner.
Well developed writing, time management, communication, presentation, analytical and interpersonal skills would be preferred.

Salary Excellent package offered
Location Europe, UK

<< Back