Pallavi Mane
Clinical & Non-Clinical Document Specialist QC Expert in Regulatory Submission and TMF Inspection readiness
- Role
- Clinical Data Management Scientist at Accenture
- Location
- Pune City, MH, IN
- LinkedIn followers
- 500 followers
About Pallavi Mane
Performed quality control checks on regulatory submissions such as CSR, ICF, Protocols…
Experience
Clinical Data Management Scientist
Jun 2022 — Present · IN
Performed quality control checks on regulatory submissions such as CSR, ICF, Protocols, RMPs, and safety documents for Health Authority and eCTD submissions as per the standards of IRDDS guidelines, ensuring technical compliance for clinical submissions documents, Ensured all document deliverables complied with Health Authority regulations, GCP, and internal SOPs.Utilized the ISI Toolbox for creation and validation of Bookmarks, Hyperlinks, TOCs, Version control, and PDF fixes using Adobe Acrobat Pro and Novstyle word application Completed and verified documentation, identified discrepancies, and took corrective actions for timely resolution.Managed document QC using Veeva vault application and fixation of identified issues in the standalone as well as Published documents using Acrobat Pro and Novstyle word applicationDeveloped and implemented performance improvement strategies to drive efficiency and promote a culture of continuous improvement as a result increased team productivity by aligning individual goals with project deliverables, fostering job satisfaction.Applied critical thinking skills to break down complex problems, evaluate solutions, and support decision-making result of that Acted as the first-line contact for business users, authors, and publishers to ensure adherence to document management standards.Collaborated directly with clients and internal stakeholders to understand requirements and deliver high-quality service and subject matter expert of project with certified trainer of the team.
Education
Jspm College of pharmacy hadapasar pune
Bachelor of Pharmacy (B.Pharm.), Pharmacy
2010 — 2012
Bharti vidhyapeeth, pune
D.Pharm, Pharmacy
2008 — 2010
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