Safety Writer

Report Writing:  Write various safety reports for global regulatory submissions, including Annual Reports, Periodic Safety Update Reports, and Risk Management Plans. Author subject narratives for adverse drug reactions and serious adverse events.
Quality Control:  Perform quality reviews of safety reports prepared by junior or associate medical writers.
Document Development:  Develop strategies for report planning, lead kick-off meetings, and handle round table discussions for comment resolution.
Regulatory Compliance:  Ensure operations comply with regulatory requirements and maintain high standards of documentation.
Literature Research:  Conduct literature searches, review articles, and author literature abstracts/summaries.
Client Interaction:  Coordinate with internal and external stakeholders to gather necessary inputs for documents.
Labeling:  Participate in the creation and updating of labels such as Core Data Sheets and USPIs.
Process Improvement:  Implement and promote efficient and quality processes to meet project timelines and deliverables.
Key

Qualifications:

Experience in safety report writing and knowledge of regulatory submission formats.
Strong communication skills and ability to work collaboratively.
Proficient in conducting literature searches and document management.
Capable of managing multiple projects with stringent deadlines