Rince Rajan
Senior Regulatory Associate (Regulatory writer) at Accenture
- Role
- Regulatory Writer at Accenture
- Location
- Bengaluru, IN
- LinkedIn followers
- 500 followers
About Rince Rajan
Authoring and leading the coordination of cross functional contributions for periodic safety update reports for international submission,including Periodic Safety Update Reports(PSUR),Periodic Benefit-Risk Evaluation Reports (PBRER),Bridging Reports (BR),Addendum Reports (AR),Periodic Adverse Experience Reports(PADER) and Addendum to clinical overview (ACO). Providing Medical Writing contribution regulatory documents including Risk Management Plans(RMP),Clinical Overviews,response to Regulatory Authority (RA) assessment reports and submission dossier requirements. Extraction of data from included studies,interpretation of study results and preparation of summaries into formal reports. Participated in Post Marketing Surveillance activities by conducting routine systemic literature reviews for specific drugs. Ensuring Quality and continuous improvement for Periodic reporting activities. Maintain and monitor the timeline compliance of all the upcoming PBRERs. Responsible foe the drug safety documentation archiving In accordance with corporate record management policies.
Experience
Regulatory Writer
May 2021 — Present · Bengaluru, IN
Authoring and leading the coordination of cross functional contributions for periodic safety update reports, renewal submission for international and Eu,including Periodic Safety Update Reports(PSUR),Periodic Benefit-Risk Evaluation Reports (PBRER),Bridging Reports (BR),Addendum Reports (AR),Periodic Adverse Experience Reports(PADER) and Addendum to clinical overview (ACO). Providing Medical Writing contribution regulatory documents including Risk Management Plans(RMP),Clinical Overviews,response to Regulatory Authority (RA) assessment reports and submission dossier requirements. Extraction of data from included studies,interpretation of study results and preparation of summaries into formal reports. Participated in Post Marketing Surveillance activities by conducting routine systemic literature reviews for specific drugs Creation of SIPOC,HLPM,DLPM,RACI,KPI,FMEA SWIs.
Education
St Francis de sales school
Cmr college of pharmacy, B.pharm
2005 — 2009
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