Description
We are looking for a
Senior Drug Safety Medical Writer (m/f)
Reference: -en
Start: asap
Duration: 12 MM+
Place: in the Basel region
Branch: Herstellung von pharmazeutischen Erzeugnissen
Your tasks:
- Periodic Safety Update Reports, Development Safety Update Reports in collaboration with the Drug Safety Physicians, Safety Report Scientists, and the Drug Safety Management
- Participate in the planning of safety reports and development of respective specifications
- Participate in literature searches and analysis
- Participate in the assessment of worldwide cases and safety evaluation
- Cooperate with other departments involved in pharmacovigilance activities (such as Global Drug Regulatory Affairs, Clinical Science & Epidemiology, Clinical Pharmacology, Global Medical Affairs)
- Participate in reviewing and quality checking of these documents to ensure high-quality documents in compliance with regulatory requirements
- Responsible for creating working electronic folders
- Involved in writing of other regulatory reports and documents to health authorities, ethics committees and/or institutional review boards (e.g. PSMF, RMP, responses to health authority’s requests)
- Perform simple searches using Argus data in response to queries for internal use
- Give feedback regarding findings in Argus data and suggest potential Argus coding manual changes and changes to the Argus QC tool
Your qualifications
- A degree in life science (e.g. BSc and/or MSc/PhD)
- English skills on native-speaker level
- Highly developed and proven medical writing skills
- Profound experience as a medical writer, preferably in the pharmaceutical industry
- Knowledge of regulatory document requirements and guidelines
- Computer literacy in Word, Excel and PowerPoint
Skills:
- Medical writer