Rushikesh Dolas Email & Phone Number

Holding Degree in Bachelor of Pharmacy, PG Diploma in Pharmacovigilance & Clinical Research and Diploma in Pharmacy.Highly detail-oriented and proactive pharmacovigilance associate with over 1 year of experience in the pharmaceutical industry. Experience in case processing in Non serious Reportable,Non serious Non Reportable cases of Spontaneous literature, Spontaneous Device, Drug, Cosmetic,Home and Hygiene and Infant child nutrition. Proven ability to work independently and manage multiple priorities in a fast-paced environment.

• 

  Pharmacovigilance Associate

  Apcer Life Sciences

  Jan 2023 - Present - Ahmedabad, Gujarat, India

  1.Data Entry of ICSRs in Pharmacovigilance database. 2.Conducting duplicate checks to ensure data integrity. 3.Entering source data into the database, utilizing systems such as IVP, ARGUS, and ARISg. 4.Assessing events and capturing appropriate MedDRA coding. 5.Verifying event listedness by referring to relevant documents like Company Core Data Sheets (CCDS) and Patient Information Leaflets (PILs). 6.Writing narratives to provide comprehensive descriptions of adverse events. 7.Raising medic… Show more 1.Data Entry of ICSRs in Pharmacovigilance database. 2.Conducting duplicate checks to ensure data integrity. 3.Entering source data into the database, utilizing systems such as IVP, ARGUS, and ARISg. 4.Assessing events and capturing appropriate MedDRA coding. 5.Verifying event listedness by referring to relevant documents like Company Core Data Sheets (CCDS) and Patient Information Leaflets (PILs). 6.Writing narratives to provide comprehensive descriptions of adverse events. 7.Raising medic assessment queries or case-specific queries. 8.Attaching source documents to the database. 9.Reconciling and movement of source documents in the appropriate folders. 10.Recording the entry in the Case Activity Tracker and relevant Client trackers Mailbox Review. 11.Forwarding valid cases to the IVP intake system. 12.Generating intake numbers in IVP intake. 13 Providing training and mentorship to new employees involved in the mailbox project. 14.Adding valid cases to various trackers, including NR (Not Reportable). 15.Case closure activities in the ARGUS database. 16.Amending the case in ARGUS database which had been migrated from IVP. 17.Attachment of CIOMS and QC Checklist. 18.Updating the relevant trackers (as applicable). 19.Case migration activities from ARISg into ARGUS database. 20.Duplicate search of IFCN Non-Serious cases in both databases (ARISg and ARGUS). 21.Migration and export of IFCN Non-Serious cases processed in ARISg into ARGUS database. 22.GRIAS and duplicate Check. 23.Updating the Excel sheet for each case. 24.ICSR validation check, attachment of QC sheet, CIOMS and reports. 25.Compliance with project guidelines. 26.Building and maintaining good relationships across functional units and company affiliates. 27.Maintaining awareness of changes to/new regulations affecting PVG activities. 28. To carry out necessary administrative duties required for the job / other duties as assigned by management. Show less