Safety Writer

Job Overview:

Responsible for the preparation and review of aggregate safety, risk management, and signal detection documents. Perform report management activities and lead client communication for the assigned reports. Assist other medical writers in their safety deliverables, act as a co-author for complex or large reports. Provide oversight and quality review of reports prepared by peers or junior associates. Conduct scientific literature searches and review for safety reports or routine surveillance activities. Ensure timely delivery of high-quality documents to internal customers and sponsors/clients. Foster excellent working relationships with all clients, both internal and external, with the highest quality of service in a cost-effective manner on time, every time.

Summary of Responsibilities:

• Perform allied activities such as data collection for report planning, developing strategy, and leading kick-off meetings and round table discussion for comment resolution.
• Write various safety reports (or part of such reports) for global regulatory submissions, including but not limited to Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Development Safety Update Report, Risk Management Plans, and other documents. Take ownership of the assigned deliverables and collaborate with internal/ client stakeholders and the client to get the required inputs.
• Perform quality review of the safety reports prepared by junior or associate medical writers.
• Author or contribute to ad hoc reports, benefit-risk evaluation reports, justification/supporting documents for label updates.
• Write Common Technical Document Summaries including Non-Clinical and Clinical Overviews, Clinical Summaries and other regulatory documents as assigned.
• Prepare medical information responses for HCPs.
• Author/contribute to signal reports (ad hoc and periodic) and safety issue analysis reports
• Write subject narratives for adverse drug reactions and serious adverse events.
• Internal and external (client) communication and co-ordination to get the required inputs.
• Participate in creating and updating labels, e.g., Core Data Sheets, USPI, centralized SPCs, Med Guides.
• Conduct literature searches for authoring several types of reports or routine surveillance activities. Review and propose updates needed if any to the search strategies. Review the articles selected by other medical writers/junior writers. Author literature abstracts/summaries and propose Company comments.
• Implement and promote use of consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures and assume accountability for the deliverables.
• Ensure compliance of operations with governing regulatory requirements.
• Create, maintain, and assume accountability for a culture of high customer service.
• Perform any additional activities as per the project requirement or manager’s discretion on completion of relevant training.
• And all other duties as needed or assigned.

Qualifications (Minimum Required):

• Minimum of first degree in life sciences (or equivalent).
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• At least 3 years' experience in the pharmaceutical industry, or at least 2 years of it in medical writing.

Experience (Minimum Required):

• Excellent command of written and spoken English.
• Good written and verbal communication skills.
• Knowledge of MS Office.
• Good organizational and time management ability.
• Excellent interpersonal skills.
• Scientific or Clinical research experience desirable.
• Good understanding of regulatory requirements, good Pharmacovigilance practices and ICH[1]GCP guidelines.

Preferred Qualifications Include:

• Advanced degree (e.g., PhD or Masters) preferred.

Physical Demands/Work Environment:

• Available for travel 5% of the time, including overnight stays as necessary consistent with project needs and office location.

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