Sakshi Panchal
Pharmacovigilance
Gurgaon
Summary
Dedicated Pharmacovigilance professional with 6.5 years of experience, seeking growth opportunities. Strong team player with excellent communication, time management, and decision-making skills
Overview
7
7
years of professional experience
Work History
Safety & PV Specialist II
SYNEOS HEALTH
08.2022 - Current
- Perform quality check and data entry of ICSRs, including clinical trial, spontaneous and solicited cases, in the ARGUS database
- Reconcile data received from clients to ensure accuracy and completeness
- Lead workshops on project-related topics to enhance team knowledge
- Generate query letters and follow up on outstanding information
- Maintain and update trackers for various purposes to ensure accurate record-keeping and workflow efficiency
- Prepared compliance reports as per client requirement.
Senior Pharmacovigilance Associate
APCER LIFE SCIENCE
09.2018 - 08.2022
- Performed quality checks for ICSRs (clinical trials, post marketing, and spontaneous etc.) within the database (ARISg and ARGUS)
- Data Entry of all types of ICSRs into databases such as ARISg and ARGUS
- Conducted booking and triaging of ICSRs
- Retrieved source data, performed coding, write narratives, and generated follow-up letters
- Reviewed literature articles to assess and identify valid ICSRs, if applicable
- Prepared aggregate and compliance reports
- Ensured adherence to project guidelines and regulatory requirements
- Provided training to new associates on case processing and database operations
- Executed company Standard Operating Procedures (SOPs)
- Managed study configuration within databases
- Supported signal detection for adverse drug reactions (ADRs) related to client products
- Maintained awareness of new and evolving regulations impacting pharmacovigilance activities
- Carried out necessary administrative duties required for the role
Education
Masters of Pharmacy - Pharmacology
Lovely Professional University
Phagwara, India 04.2001 -
Bachelor in Pharmacy - Pharmacy
CT Group of Institute
Jalandhar, India 04.2001 -
Skills
- Quality checks, Data entry, Triage and Client Mailbox Handling
- SOP Documentation
- Compliance Reporting
- Governance Data
- Audit Management
- Data Reconciliation
- Training Management
- Workshop Facilitation
Database
- ARGUS
- ARISg
Publications
- Systematic overview on treatment of cardiac disease (International Journal of Pharma Science and Research, 2016)
Timeline
Safety & PV Specialist II
SYNEOS HEALTH
08.2022 - Current
Senior Pharmacovigilance Associate
APCER LIFE SCIENCE
09.2018 - 08.2022
Masters of Pharmacy - Pharmacology
Lovely Professional University
04.2001 -
Bachelor in Pharmacy - Pharmacy
CT Group of Institute
04.2001 -
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