Safety Writer

3 weeks ago


Pune, Maharashtra, India Thepharmadaily Full time
Job Description

Process Implementation:

- Implement and promote the use of consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures.
- Ensure compliance of operations with governing regulatory requirements.
- Create, maintain, and assume accountability for a culture of high customer service.

Literature Search and Reporting:

- Conduct efficient literature searches for authoring various types of reports.
- Author/review various safety reports (or parts of such reports) for global regulatory submissions for Fortrea s clients.

These reports include:

- Annual Reports (IND and others)
- Periodic Safety Update Reports
- Periodic Adverse Drug Experience Reports
- Periodic Benefit-Risk Evaluation Reports
- Bridging Reports
- Other clinical documents as assigned.

Signal Detection and Risk Management:

- Perform/review signal detection activities.
- Author/review Risk Management Plans (RMP), ad hoc reports, Safety Update Reports, Benefit-Risk Evaluation, CCDS supporting documents, ACOs, and Addendum Reports.

Allied Activities:

- Generate line listings and summary tabulations.
- Perform CFIs and CFCs.
- Search literature databases for relevant information, recommend label changes, author proposed label text, and prepare supporting/justification documents.

SOPs and Training:

- Author/review SOPs, Work Instructions (WIs), process documents, or sections as applicable.
- Conduct training for peers and team members.

Additional Responsibilities:

- Perform any additional activities as per project requirements or manager s discretion upon completion of relevant training.

Knowledge and Skills:

- Strong understanding of regulatory requirements and safety reporting.
- Proficiency in literature search and data analysis.
- Excellent communication and writing skills.
- Ability to manage multiple tasks and deliver high-quality results under tight deadlines.
- Strong project management and organizational skills.

Experience:

- Relevant experience in a similar role within the pharmaceutical, biotechnology, or medical device industries.

Education:

- Bachelors degree in a related field (eg, Life Sciences, Pharmacy, Medicine) required

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