Safety Writer

0-5 years

Not Disclosed

Pune

10 May 27, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description: Safety Report Specialist

Company Overview:

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Position: Safety Report Specialist

Key Responsibilities:

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.

Qualifications:

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:
- Bachelor's degree in a related field (e.g., Life Sciences, Pharmacy, Medicine) required.

Company Values:

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

Equal Opportunity Employer Statement:

Fortrea is proud to be an Equal Opportunity Employer. As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our Privacy Statement.

This structured format provides a clear and detailed outline of the job responsibilities, qualifications, company values, and equal opportunity statement for potential applicants.

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Safety Writer

Job Description

Job Description: Safety Report Specialist

Company Overview:

Position: Safety Report Specialist

Key Responsibilities:

Qualifications:

Company Values:

Equal Opportunity Employer Statement:

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