Cognizant
Location
Secunderabad | India
Job description
Risk management scientist:
Job description:
- Create, update, and finalize necessary template and final reports with the relevant approvers.
- Identify relevant stakeholders, hold strategy call with line functions and manage round table reviews with stakeholders
- Manage internal / external communications required to provide high quality draft of reports
- Retrieval of relevant documents from client Shared drive, as required.
- Ensure overall quality and consistency (i.e. between different sections/annexes of the RMP/B-R report and with reference source documents, e.g., labelling document, clinical and non-clinical study report, Summary of clinical safety, Clinical overviews, statistical outputs, literature documents, response documents, PSUR/DSUR and other documents as required)
- For RMP updates, create a new track change version and a new clean version reflecting all changes made to the RMP, fulfilling standards for regulatory submission
- Work with medical reviewers to ensure that the report is medically reviewed by all relevant stake holders, and inputs for section where medical reviewer is responsible are properly incorporated. Benefit-Risk management review is performed and incorporated in relevant sections of the report
- Incorporating/ addressing feedbacks/comments from various stakeholders including safety team, Quality Check (QC) team and QPPV (as required)
- Peer review of drafted document by other authors ensuring that all client requirements for quality are met, or
- Be part of the separate team to provide independent quality comments on the drafted document and fill necessary checklists documenting the review
- Prepare/ compile the final document
- If required, creates a redacted version when required and implements review comments from the reviewers
- Also archive all source data for the report on client Shared drive, including all draft and reviewed versions
- Ensure client approval on the final report and update report tracker with all Key Performance Indicator (KPIs)
- Training and mentoring of other RMP writers
- Any other activity based on client request
Experience:
- Minimum 4 years of experience in Pharmacovigilance AND
- Minimum 2 years of experience in aggregate report writing (PSUR, DSUR or AdCO) AND minimum 1 year of experience in RMP writing
Qualification:
- B.Pharm/M.Pharm/Ph.D./BDS/BHMS/BAMS/Masters in life science
Competencies:
- Good negotiation, project management and communication skills.
- Experience in managing global, cross-functional teams or simple global projects, along with advanced knowledge of biostatistics principles will be desirable.
Employee Status : Full Time Employee
Shift : Day Job
Travel : No
Job Posting : Feb 26 2024
About Cognizant
Cognizant (Nasdaq-100: CTSH) is one of the world's leading professional services companies, transforming clients' business, operating and technology models for the digital era. Our unique industry-based, consultative approach helps clients envision, build and run more innovative and efficient businesses. Headquartered in the U.S., Cognizant is ranked 185 on the Fortune 500 and is consistently listed among the most admired companies in the world. Learn how Cognizant helps clients lead with digital at or follow usJob tags
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