Prajakta Mane
PV Operations Specialist: Regulatory Reporting by VEEVA RIMS at IQVIA | PVA Specialist: QC of PV Agreements, review of SDEA docs | Quality review Sapphire DB | Ex Cognizant (Arisg, AgXchange, LifeSphere Multi Vigilance)
- Role
- Operations Specialist at IQVIA
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Prajakta Mane
Experienced, team-oriented individual with strong interpersonal skills, adaptability, and flexibility. Ability to work in challenging situations. I look forward to enriching my skills and moving ahead in my career while contributing my best to the organization.
Experience
Operations Specialist
May 2021 — Present · Maharashtra, IN
Regulatory Reporting Specialist:• Reporting of Pre marketing and post marketing reports (PSUR/PBRER, DSUR) to regulatory authorities by using VEEVA Database. Creation of new event or updating previously reported events and updating the submission details as per the SOPs. Submitting reports based on the countries and their agreements with other companies.PVA specialist: • Performs Quality review of PV agreements and identify if any errors there in the MAPS tracker and inform the error sheet to respected LOC teams for correction process. • Initiation of implementation and termination checklists. • Review of SDEA documents for the timelines of signal detection, emergency issues, RMP, labelling and other timelines from the PVA database.Quality review: Covid-19 Vaccine cases. • As a Quality Reviewer for cases using the SAPPHIRE safety database, which includes ICSR, SUSAR, and other tools.• Post marketing Spontaneous and Solicited cases. The review of the license partner report is also included.• Experienced with reviewing and processing vaccine reports in the safety database.• Provide feedback to Case Processing Team members on the errors discovered and contribute to the process\'s overall quality improvement.• Conducting daily huddles and sharing client feedback, as well as providing updates to all team members, and training individuals on case processing in accordance with client conventions and database.• Handle different trackers for overall quality improvement and provide daily feedback to respective team member.• Sending repot on MHRA last name and local language narrative and case closer status.• I have been a point of contact for RQC error discussion.• Did other activity such as Team meetings, responsible for Team Quality, Case corrections, Giving Training and Mentoring for new joiners etc.
Education
Gahlot Institute of Pharmacy India
Bachelor of Pharmacy, Pharmacy
2013 — 2017
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