Sheetal
Kannur,Kerala
Summary
Experienced pharmacovigilance professional with expertise in processing Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs), while ensuring submission within regulatory timelines to clients, regulatory authorities, and ethics committees. Adept in utilizing Argus safety database, electronic data capture systems, clinical trial management systems and Veeva vault. Reputation for hard work, punctuality and willingness to learn new things.
Overview
4
4
years of professional experience
6
6
years of post-secondary education
1
1
Certification
Work History
Associate I Patient Safety Solutions
Fortrea Clinical Development Private Limited
Bengaluru
2022.11 - Current
- Processed and reviewed safety reports originating from clinical studies, and post-marketing surveillance, ensuring thorough causality and expectedness assessments, as well as detailed narrative writing.
- Managed the timely and accurate completion of safety reports for distribution to Health Authorities, clients, and their partners, maintaining compliance with regulatory timelines and requirements.
- Assisted in the reconciliation of clinical and safety databases, ensuring alignment and accurate data flow between systems.
- Coordinated and executed User Acceptance Testing (UAT) in collaboration with cross-functional teams, including the Argus team, for system updates and enhancements.
- Provided pharmacovigilance operations support for client audits and regulatory inspections, ensuring readiness and adherence to compliance standards.
- Ensured the quality and accuracy of all safety data used in regulatory documents, including safety reports, aggregate data, and line listings, adhering to regulatory guidelines.
Drug Safety Associate Trainee
IQVIA
Bengaluru
2021.03 - 2022.11
- Managed individual case safety reports of all case types (serious and non-serious cases from spontaneous and solicited programs, E2B cases).
- Hands on expertise in end to end case processing in Argus 8 Database.
- Conduct follow up activities as per the case requirements.
- Therapeutic experience in Phase IV trials of Infectious Diseases Viral Infection Coronavirus Disease (COVID-19)
- Worked productively with team members to achieve common goals.
- Sought feedback actively and used it to improve performance.
Education
Master's degree - Pharmaceutical Quality Assurance
SRM College of Pharmacy
2018.07 - 2020.06
Bachelor of Pharmacy - Pharmacy
JSS College of Pharmacy
2013.07 - 2017.06
Skills
- Case processing
- Argus safety database
- Electronic data capture (EDC)
- Clinical trial management system
- eTMF
- Client Communication
- CAPA
- SAE reconciliation
- MedDRA coding
- Line Listings
- Due diligence activities
- User Acceptance Testing (UAT)
Languages
English
Fluent
Hindi
Fluent
Accomplishments
- ACE Award for quality case processing
- ACE award for Process excellence
Certification
- Member of Pharmaceutical Information and Pharmacovigilance Association (PIPA)
- LinkedIn Learning: Lean Six Sigma: Define and Measure Tools
- LinkedIn Learning: Six Sigma Foundations
- LinkedIn Learning: Lean Six Sigma Foundations LinkedIn
Timeline
Associate I Patient Safety Solutions
Fortrea Clinical Development Private Limited
2022.11 - Current
Drug Safety Associate Trainee
IQVIA
2021.03 - 2022.11
Master's degree - Pharmaceutical Quality Assurance
SRM College of Pharmacy
2018.07 - 2020.06
Bachelor of Pharmacy - Pharmacy
JSS College of Pharmacy
2013.07 - 2017.06
- Member of Pharmaceutical Information and Pharmacovigilance Association (PIPA)
- LinkedIn Learning: Lean Six Sigma: Define and Measure Tools
- LinkedIn Learning: Six Sigma Foundations
- LinkedIn Learning: Lean Six Sigma Foundations LinkedIn
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