Company: Mosaic Regulatory Solutions
Closing Date: 17 Nov 16
Salary (£): On Application
To apply for this Medical Scientist role please call Julie Cooper on 07951 082482 or send your CV to: firstname.lastname@example.org
Role - Medical Review Scientist- PV , Pharmacovigilance Group
Location - Belgium
In order to strengthen the Global Safety Surveillance group, we are currently looking for a Medical Review Scientist (m/f).
Your Responsibilities includes but not limited to:
primary responsibility is to provide accurate and up to date medical responses to product enquiries from healthcare professionals and customers in a professional, ethical, compliant and timely manner.
Ensures that the company's medicines are used safely and effectively.
Answering medical enquiries + tracking questions and answers
Develop and update readily accessible bibliographies, standard response letters (SRLs) and frequently asked questions (FAQs) on major products while ensuring medical/scientific accuracy.
Review provided local answers to medical enquiries in the different countries
Escalate important issues as they arise to management colleagues and ensure adverse event and quality reporting, in compliance with Pharmacovigilance and Quality department guidelines.
· To assure medical validity and provide input to the activities of Medical Safety Review Team
To execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports
To act as a significant point of contact between DSOs (Drug Safety Officers) on medical content and regulatory reporting of ICSRs
Review and validation of signal relevant articles
Investigate potential signals (literature, database, safety documents)
Assist in the medical review of aggregate safety documents (PBRER/PSUR and ACO)
Review of Risk Management plans
Provide expertise for all safety related medical tasks
Assess safety information related to the preparation and revision of SmPCs.
Conduct medical review and advise on responses to regulatory inquiries
Available to support reconciliation activities as directed (e.g. for drug safety/product quality)
- Medicine degree
- Quick & reactive learner
- Highly analytical, process minded and detail oriented.
- Be able to work in a matrix environment whilst remaining organized at all times.
- You have a hands on-mentality and a proactive attitude.
- You are fluent in English and have excellent communication skills. Knowledge of other European languages is an asset.
- You are a true team player.
Mosaic Regulatory Solutions Ltd
|Tel:||0208 305 9733|
|Website:||Visit Our Web Site|
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