21/06 Shweta Chaskar
Senior Talent Acquisition Specialist at SIRO Clinpharm

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SIRO Clinpharm - Drug Safety & Risk Management Writer (4-10 yrs)

Mumbai Job Code: 14884

Role: DSRM (Drug Safety and Risk Management) Team

Position Summary:

- Drug Safety & Risk Management writer to perform authoring, standalone QC, data QC and scientific review of DSRM documents like DSURs, RMPs, PSURs/ PBRERs, PADERs, SUSAR LLs & other aggregate reports.

- Perform above mentioned activities in compliance with established standards, performance metrics and with minimal oversight/ supervision.

- Perform project management activities with supervision from reporting manager.

Key Responsibilities :

- Draft and review of DSRM documents like DSURs, RMPs, PSURs/ PBRERs, PADERs, SUSAR LLs & other aggregate reports in accordance with documented guidelines, SOPs, and timelines. Ensure that the data is objectively and accurately represented. Responsible for the final deliverable in terms of timelines and quality.

- Effectively manage assigned Drug Safety & Risk Management writing activities & build expertise across the different document types assigned through imparting medical/ clinical knowledge.

- Effective project management and optimal project utilization: ensuring maximum productivity per assigned work load and defined metrics.

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