Fortrea Hiring Freshers Regulatory Safety Writer in Pune apply Now
About Company
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 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 Name : Safety Writer
Organization :Fortrea
Qualification:B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences
Experience: 0 YEARS / Freshers – 1 Year
Salary: ₹4L – ₹5L/yr
Location: pune
- 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.
- Conduct literature searches for authoring various types of reports efficiently.
- Author/review various safety reports for global regulatory submissions, including Annual Reports, Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Periodic Benefit-Risk Evaluation Reports, Bridging reports, and other clinical documents as assigned.
- Perform/review Signal detection activities.
- Author/review RMP, ad hoc reports, Safety Update reports, Benefit-Risk Evaluation, CCDS supporting document, ACOs, Addendum reports.
- Perform allied activities like generation of line listings and summary tabulation, CFIs, CFCs.
- Search literature databases for relevant information, recommend label changes, author proposed label text, and prepare supporting/justification documents.
- Author/review SOPs/WIs/process documents or sections as applicable.
- Conduct training sessions for peers and team members.
- Perform any additional activities as per the project requirement or manager’s discretion upon completion of relevant training.
Qualifications:
- Motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials.
- Commitment to revolutionizing the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need.
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