- Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.)
- To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings.
- Performs activities related to the preparation, writing and review of safety portions of Periodic Aggregate Safety Reports (PBRER, DSUR etc.)
- To perform compilation of all global and country specific periodic aggregate safety reports
- assigned by the supervisor.
- To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline.
- To track and drive the progress of safety periodic reports as per the client defined timelines.
- To ensure compliance to SOPs (client e-manuals and training modules) and other process
- related documentation.
- Drafting and maintaining PV agreements and SDEA'S Workflow management along with case allocation
- Accountable for updating relevant databases, repositories, trackers and logs on an ongoing basis as per relevant SOPs
- Submission of cases to various regulatory Authorities (EMA, MHRA, FDA, Health Canada)
- Execute drug safety data management process- a combination of case intake, triage, case entry, medical coding, narrative writing, peer review, case follow-up, report preparation- with accountability for quality and timelines of deliverables and responsibility for process improvements
- Maintaining and drafting project level SOPs as per Statement of Work.
- Create/collate periodic reports for client report meetings.
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Role & responsibilities: · Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) · To perform all pre-DLP activities and planning for all assigned reports as per client ...
Pune, Mumbai, Mumbai City Full time5 days ago
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Review protocol and provide suggestions · Respond to queries/ clarifications from EC/ IRBs · Answer medical questions from sites or project team · Respond to queries from sites with regard to protocol · Attend drug safety meetings/ external meetings · Patient eligibility review · ...
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The Identity and Access Management (IAM) team provides services for Nokias workforce and business-to-business domains. Our diverse global team maintains over a dozen IAM-related services in legacy on-premises and modern cloud landscapes. Nokia IAM is currently focused on renewing ...
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Outpace Consulting Services is seeking an Aggregate Report Writer specializing in Pharmacovigilance (PV) Aggregate Reporting for a leading ITES company in the Life Sciences domain. In this role, you will be responsible for the end-to-end process of preparing, writing, and reviewi ...
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Life Science - Pune, Mumbai - Outpace Consulting Services
Description
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Life Science
Full time Outpace Consulting Services- Pune, Mumbai
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Life Science
Full time Outpace Consulting Services- Pune, Mumbai, Indore
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Life Science
Full time Outpace Consulting Services- Pune, Mumbai
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Life Science
Full time Outpace Consulting Services- Pune, Mumbai, Mumbai City
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Life Science
Full time Outpace Consulting Services- Pune, Mumbai, Bengaluru / Bangalore
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IDM T2 Specialist
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MS IP Specialist
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Aggregate Report Writer
Full time Outpace Consulting Services- Pune, Mumbai, Mumbai City