Shikha Vijay Rane
Pune
Summary
Dynamic Safety and Pharmacovigilance Specialist with expertise in Argus and Aris Global databases, adept at ensuring compliance and quality in ICSR processing at Syneos Health, TCS and Cognizant technology solutions. Proven good associate with strong problem-solving skills, delivering timely regulatory submissions and enhancing data management efficiency. Committed to excellence in medical safety reporting.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Safety and Pharmacovigilance Specialist
Syneos Health
Pune
09.2020 - 04.2025
- Worked on the Argus database, Safety Reporting mailbox (shared), mailbox management, IMedidata (Rave), Veeva Vault, Veeva Clinical, and Trackwise database.
- Worked on clinical trial cases.
- Entered information into PVG quality and tracking systems for the receipt and monitoring of ICSRs.
- Assisted in processing ICSRs following Standard Operating Procedures (SOPs) and safety plans.
- Triaged ICSRs, case processing- Solicited, spontaneous, clinical trail, E2B and pregnancy cases (evaluating data for completeness, accuracy, and regulatory reportability), and case quality review.
- Entered comprehensive data into safety database, coding events, medical history, and medications.
- Compiled complete narrative summaries to support reporting processes.
- Identified missing information for queries and ensured resolution through follow-up.
- Generated timely and accurate expedited reports in compliance with regulatory requirements.
- Submitted all relevant documents to Trial Master File (TMF) as per SOP and sponsor guidelines.
- Training for newly joined associates.
Drug Safety Specialist (Pharmacovigilance)
Tata Consultancy Services
Thane
08.2019 - 01.2020
- Worked as a quality reviewer and ICSR case processor.
- Worked on the ArisG Database, the IRT Database, and the MedDRA tool.
- Processed Spontaneous and Solicited cases.
- Receiving the cases in the Arisg workflow with source documents.
- Selection and coding of event terms.
- Concomitant medication, lab data, death details, and medical history.
- Writing a detailed, medically oriented description of the events in the form of a safety narrative.
- Evaluate the entered cases according to the quality review checklist in terms of quality, accuracy, and completeness, as the source documents provided.
- Meeting the timelines and supporting global regulatory submissions.
Junior Data Analyst
Cognizant technology solution LTD
03.2017 - 07.2019
- Executed individual case safety reporting (ICSR) case processing, triage (case initiation).
- Reviewed quality of medical safety cases to ensure compliance.
- Generated product quality complaint PQC reports to support regulatory requirements on the Trackwise Soltraqs database.
- Training for newly joined associates.
- Team handling for a maximum of 5 associates in case initiation activity, handling the mailbox, and case distribution within the team.
Drug Data Analyst
SYSTEM TWO ONLINE SOLUTION PVT LTD (HIRA GROUP RAIPUR)
Raipur
09.2015 - 01.2017
- Current Project: HealthPotli - An Android/iOS healthcare application (online pharmacy).
- Managing the drug and general products database in Excel.
- Update an application by providing correct drug, and general wellness product data to achieve quality.
- Interpret the drug data correctly.
- Analyze attributes of drug data using authenticated sources from the web and sources provided.
- Provide reports for the ongoing tasks.
- Correct understanding of medical prescriptions, coordinating with vendors, and validating them properly.
- Knowledge related to the brand name of the medicines, and their substitutes.
- Track new products and do data entry as necessary.
- Closely coordinate with the customer support team.
- Send and receive email messages to and from the customer services team to solve the issues in the specified time frame.
- Inventory management involves overseeing and controlling the quantities of finished products for sale.
Education
M.Pharmacy - Pharmaceutics
Columbia Institute Of Pharmacy
Raipur07.2015
B. Pharmacy -
Manohar Bhai Patel Institute of Phrmacy, Gondia
Gondia05.2013
Skills
- Argus and Aris Global databases
- MS Office proficiency
- Data management
- Customer service
- Medical terminology
- Team leadership
- Problem solving
Languages
- English
- Hindi
- Marathi
Disclaimer
I here by declare that, the above information is correct.
Personal Information
Date of Birth: 07/15/1991
Place: Hadapsar, Pune
Accomplishments
Miss Pharma 2012
- Winner of the Miss Pharma competition in 2012 at college
Affiliations
Social activism, dancing, singing, and traveling
Certification
- Recognized as the star of the month in the previous organization
Timeline
Safety and Pharmacovigilance Specialist
Syneos Health
09.2020 - 04.2025
Drug Safety Specialist (Pharmacovigilance)
Tata Consultancy Services
08.2019 - 01.2020
Junior Data Analyst
Cognizant technology solution LTD
03.2017 - 07.2019
Drug Data Analyst
SYSTEM TWO ONLINE SOLUTION PVT LTD (HIRA GROUP RAIPUR)
09.2015 - 01.2017
M.Pharmacy - Pharmaceutics
Columbia Institute Of Pharmacy
B. Pharmacy -
Manohar Bhai Patel Institute of Phrmacy, Gondia
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