2 March, 2022
About the job
Site Name: India – Andra Pradesh – Hyderabad
Posted Date: Nov 11 2021
Consumer Healthcare has a large portfolio of products including medicines, cosmetics, medical devices and dietary supplements. The CS Report Writing Specialist is accountable for production of safety documentation for all product types in alignment with national reporting requirements to support local, regional and global regulatory submissions.
The Position Holder Will
- Support CS Science staff with authoring and development of benefit-risk assessments, safety risk management plans, safety signal evaluations, regulatory submissions and aggregate reports.
- Produce fit-for-purpose safety documentation across CH categories of high quality and according to defined timelines
- Prepare safety writing deliverables, including planning, authoring, contributing to safety strategy and data analysis, coordination with contributing functions, and quality control of assigned safety writing projects from initiation to completion.
- Maintain product safety information at active level and ensure consistent use across regulatory reports.
- Use appropriate sources of information and database searches to retrieve relevant data for inclusion to safety reports
- Review published literature for identifications of safety signals and/or inclusion into periodic reports.
- Serve as the principal owner and co-ordinator of the safety deliverables and have responsibility for completion of the deliverable in compliance with Company guidelines.
- Produce or contribute to safety documentation for regulatory submissions and to fulfil legal obligations of the MAH. Examples include but are not limited to Safety Risk Management Plans, Periodic Benefit Risk Evaluation Reports, Developmental Safety Update Reports, Medical Device Periodic Safety Update Reports, Cosmetic Undesirable Effects Reports, Canadian Annual Reports, US Periodic Adverse Drug Experience Reports, and Clinical Overviews and Summaries.
- Provide safety summaries in support of communication on relevant safety information both, internally and externally.
- Assist CS Science team in producing regulatory supporting documentation for labelling updates and in performing routine signal detection activities (e.g. review of ICSRs)
- Accountable for maintaining personal readiness in response to internal audit or regulatory inspection
- With guidance, contribute to process improvement initiatives within Consumer Safety
Apply through below link