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Safety Writer

0 - 3 years

3 - 7 Lacs

Mumbai Maharashtra India

Posted:1 day ago| Platform: Foundit logo

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Skills Required

safety documentation Training Thepharmadaily safety manuals

Work Mode

On-site

Job Type

Full Time

Job Description

Key responsibilities include:

  • Perform data collection for report planning and strategy development.
  • Write safety reports for global regulatory submissions, including Annual Reports, Periodic Safety Update Reports, and more.
  • Conduct quality review of safety reports prepared by junior or associate medical writers.
  • Author or contribute to ad hoc reports and benefit-risk evaluation reports.
  • Prepare medical information responses for healthcare professionals.
  • Contribute to signal reports and safety issue analysis reports.
  • Author subject narratives for adverse drug reactions and serious adverse events.
  • Participate in label creation and updates, including Core Data Sheets and Med Guides.
  • Conduct literature searches and review articles for various reports and surveillance activities.
  • Implement consistent and efficient processes to meet timelines and quality standards.
  • Ensure compliance with regulatory requirements and promote a culture of high customer service.
  • Perform additional activities as per project requirements and managers discretion.

Qualifications:

  • Bachelors and/or Masters degree in Healthcare or related field.
  • Strong communication and writing skills.
  • Familiarity with clinical research and regulatory requirements.
  • Ability to work collaboratively in a dynamic environment.
  • Detail-oriented with strong organizational skills.

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