Anuradha Solanki

Experienced Pharmacovigilance Professional with over 9+ years of pharmaceutical industry experience, including 6+ years in Pharmacovigilance specializing in ICSR Case Processing, Triage, Quality Review, and Drug Safety Operations. Strong expertise in Argus Safety, Sapphire, and CARA databases, medical coding, narrative writing, case management, and quality compliance. Proven ability to maintain high-quality standards while meeting strict regulatory timelines.

Recognized as a top performer with experience mentoring team members and supporting audit readiness.

Case Processor & Quality Reviewer - Tata Consultancy Services (TCS) - Mumbai

(2020-06)

• Process spontaneous and solicited Individual Case Safety Reports (ICSRs).
• Perform case triage, book-in activities, and case lifecycle management.
• Enter and validate safety data with high accuracy in Argus Safety.
• Prepare clear and medically accurate case narratives.
• Perform medical coding and product coding.
• Conduct duplicate checks and case reconciliation.
• Execute case corrections and quality review activities.
• Ensure compliance with regulatory timelines and quality standards.
• Route, lock, and close safety cases.
• Review processed cases for accuracy and completeness.
• Handle special scenario cases and complex safety reports.
• Generate action items and coordinate with cross-functional teams.
• Mentor new team members and support training activities.
• Served as Backup Team Lead during operational requirements.
• Databases Used: Argus Safety, Sapphire, CARA

Quality Assurance Executive - Qualigens Pharma Pvt. Ltd.

(2016-01 - 2017-02)

• Batch Manufacturing Record (BMR) preparation.
• Batch Packaging Record (BPR) documentation.
• Process Validation Protocols and Reports.
• SOP preparation and revision.
• Change Control, CAPA and Deviation handling.
• Regulatory documentation support.
• Internal and external audit coordination.
• Training coordination across departments.
• Documentation support for Regulatory Affairs.

Quality Assurance Executive - Milan Laboratories (I) Pvt. Ltd.

(2017-02 - 2019-09)

• Batch Manufacturing Record (BMR) preparation.
• Batch Packaging Record (BPR) documentation.
• Process Validation Protocols and Reports.
• SOP preparation and revision.
• Change Control, CAPA and Deviation handling.
• Regulatory documentation support.
• Internal and external audit coordination.
• Training coordination across departments.
• Documentation support for Regulatory Affairs.

Quality Assurance Executive - Raptakos Brett & Co. Ltd.

(2019-10 - 2020-06)

• Batch Manufacturing Record (BMR) preparation.
• Batch Packaging Record (BPR) documentation.
• Process Validation Protocols and Reports.
• SOP preparation and revision.
• Change Control, CAPA and Deviation handling.
• Regulatory documentation support.
• Internal and external audit coordination.
• Training coordination across departments.
• Documentation support for Regulatory Affairs.

Bachelor of Pharmacy - Pharmacy - R.J.S.P.M. College of Pharmacy, Pune University (2015)