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Job Details

Senior Drug Safety Medical Writer

Company: CTC Resourcing Solutions
Location:
Reference: 895743-P
Closing Date: 16 Mar 18
Type: Contract
Salary (£): On Application
Benefits:

Job Summary:

Our client is a leading biopharmaceutical company, currently looking for a “Senior” Drug Safety Medical Writer

Requirements:

Reference Number:          895743-P

Type of placement:          Contract, 12 months

Location:                        Basel area, Switzerland

                                      

Main Responsibilities

Responsibilities related to safety reports

  • Be a lead author of periodic safety documents (e.g. Periodic Benefit Risk Evaluation Reports [PBRERs]/
  • Periodic Safety Update Reports [PSURs], Development Safety Update Reports [DSURs]) 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, as required.
  • Participate in the assessment of worldwide cases and safety evaluation, as required.
  • 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 for PBRERs/PSURs on a shared, access-protected drive according to SOP-000067.
  • 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 authorities requests), as required.

Internal and External Communication

  • Participate actively in project, group and team meetings, on local and global level.
  • 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.
  • Inform Head Medical Safety Surveillance, Drug Safety Physician and Head of Drug Safety of any critical issues.

Other responsibilities include:

  • Take charge of specific projects, as required.
  • Support Drug Safety Physicians in preparation of documents and presentations.
  • Participate in writing and updating of standard operating procedures (SOPs) and working instructions (WIS).
  • Provide training on medical writing to colleagues.

 

Qualification / Experience

  • A degree in life science (e.g. BSc and/or MSc/PhD).
  • English mother tongue or excellent English skills.
  • Highly developed and proven medical writing skills.
  • 3 -5 years of experience as a medical writer, preferable in the pharmaceutical industry.
  • Knowledge of regulatory document requirements and guidelines.
  • The ability to work independently and as part of a team.
  • The ability to work under pressure, to prioritize tasks, and to meet challenging deadlines.
  • Strong analytical skills.
  • Excellent organizational, problem solving, interpersonal and presentation skills.
  • Computer literacy in Word, Excel and Power Point.
  • Relevant working/residency permit or Swiss/EU-Citizenship required

Apply for this job: Senior Drug Safety Medical Writer

Contact Information:

Address:  CTC Resourcing Solutions
Greifengasse 1
CH-4058 Basel
Switzerland
Reasons to work for CTC
Tel:  +41 61 695 88 66
Fax:  +41 61 695 88 67
Website:  Visit Our Web Site

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