DSUR Writing - Pharmacovigilance
- Golden Opportunities
- 2 - 10 Years
- Chennai
- 4 years ago
- Email to a friend
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Job Description
Job Role: DSUR WriterPreferred Educational Qualification for the role:
Doctors (MBBS BAMS BHMS BDS MS/MD PhD) and/or graduate/postgraduate in life science pharmacy or nursing.
Preferred experience for the role:
More than 2 years of experience in medical writing and/or pharmacovigilance.
Responsibilities :
Preferred experience for the role:
More than 2 years of experience in medical writing and/or pharmacovigilance.
Responsibilities :
- To perform safety periodic writing including assessment analysis and authoring of Development Safety Update Report (DSUR) assigned by the supervisor.
- To effectively operate in an environment that requires negotiation persuasion collaboration and analytical judgment.
- To have thorough knowledge to the tools and databases required during the process
- To understand and interpret data/information and its practical application.
- To perform all Pre-DLP activities and planning for all assigned reports as per the CLIENT training including conducting Kick off Meetings.
- To draft and review SUSAR narratives.
- To request and ensure the receipt of contribution from the various stake holders necessary for authoring of the assigned reports.
- To ensure the completion of authoring QC review of the assigned reports within the specified timelines
- To perform peer review of the assigned DSUR and complete the corresponding QC checklists.
- To provide daily progress update regarding the status of the assigned reports to the supervisors.
- To track and ensure that the progress of reports is as per the client defined timelines.
- To ensure the timely completion of all activities and trackers maintained for the project.
- To ensure the completion of all assigned project related activities assigned by the supervisors.
- To ensure compliance to SOPs and other process related documentation.
- To impart trainings mentor and groom the new associates.
- To provide innovative suggestions and ideas for process optimization.
- To ensure that all DSUR related trainings are completed within allotted time period.
- To achieve the supporting documents in respective repositories for reference.
Employement Category:
Employement Type: Full timeIndustry: Bio Technology & Life SciencesFunctional Area: PharmaceuticalRole Category: Quality Control ManagerRole/Responsibilies: DSUR Writing - PharmacovigilanceContact Details:
Company: Golden OpportunitiesLocation(s): Chennai+ View Contact
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