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Vacancy Details

Vacancy posted by: Flame Pharma

Job Title: Drug Safety Associate

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Vacancy details Vacancy description:
Job Code:
WR/NOT09/23623
Job Title:
Drug Safety Associate
Job Category:
Regulatory And Drug Safety
Contract:
Permanent
Discipline:
Any Discipline
Country:
Czech Republic
Location:
Any Location
Min experience:
N/A
Annual salary:
Negotiable
Apply by:
08 Jul 2008
Drug Safety Associate Job - Europe (Czech Republic):
Job Summary

Do you have proven experience in either drug safety or pharmacovigilance?Are you looking to build upon your existing knowledge and experience in a European location? If the answer is yes, Flame Pharma would like to hear from you today.
Flame Pharma are currently working alongside a globally renowned CRO who are offering the right candidate an exciting new European challenge to develop and expand their professional career within Drug Safety.

Job Title
Drug Safety Associate

Background
Due to expansion our client is looking for a Drug Safety Associate to be based in Eastern Europe (Prague). The ideal candidate will have a clear understanding of drug safety and the drug development process.
Key Responsibilities and Duties
The Drug Safety Associate will be based in the Drug Safety / Pharmacovigilance department.
The Drug Safety Associate will provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).
• The Key Accountabilities will include Triage of incoming reports for completeness, legibility and validity.• Initial data entry of case reports into safety database / tracking system• Assessment of requesting follow-up i.e. written, telephone.• Adverse event (AE) and drug coding of case reports for seriousness, causality and expectedness.• Writing case narratives.• Create and maintain project specific working files, case report files and project central files.• Assist with additional Drug Safety Specialist activities as required.• Inform Medical & Drug Safety Managers and Regional Head of Pharmacovigilance Operations of potential change-in-scope of projects.• Work with Medical Directors/Safety Physicians, as needed, with medical monitoring activities.

Qualifications, Experience and Knowledge
• Graduate - Degree in Life Sciences, Pharmacy or Nursing or another relevant subject.• Proven experience in either Drug Safety or Pharmacovigilance in either a Clinical Research or Pharmaceutical background.Excellent communication skills both written and verbal.• Time management skills.• Client focused approach to workload.• Experience with computer applications including database management.• Team player, Able to work as an individual or as part of a team.

Benefits
With this position comes an attractive benefits package that you associate with a global provider, including pension, healthcare, plus an attractive salary.

Key Words
Drug Safety, CRO, Pharmacovigilance, Professional, Clinical Research, Pharmaceutical, Analytical, Czech Republic, Europe, Czech Republic, Prague.
The position will be based in Eastern Europe (Czech Republic).

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