Anu Bala
Drug Safety Associate II
Gurgaon
Summary
Pharmacovigilance professional with 5+ years of experience in ICSR processing, triage, data entry, and quality review across spontaneous, clinical trial, solicited, and literature cases. Proficient in MedDRA coding, ARISg safety database, and regulatory frameworks (ICH, FDA, CIOMS, EU PV). Experienced in mentoring DSA's and ensuring compliance with safety standards.
Overview
7
7
years of professional experience
Work History
Drug Safety Associate II
PAREXEL International
04.2022 - Current
- Mentored and trained Drug Safety Associates to ensure accurate MedDRA coding and ICSR processing.
- Conducted reconciliation and triage activities to identify serious cases at data entry.
- Performed quality reviews of ICSRs to ensure compliance with client and regulatory requirements.
- Liaised with client personnel to resolve case-related issues.
- Participated in literature screening for adverse event identification.
- Maintained monthly correction trackers for quality monitoring.
Drug Safety Associate I
PAREXEL International
12.2019 - 04.2022
- Managed end-to-end processing of ICSRs across various case types (spontaneous, clinical trials, solicited, literature).
- Performed triage to determine expedited reporting requirements and regulatory timelines.
- Conducted duplicate searches, data entry, validation, and narrative writing in safety databases.
- Ensured accuracy of MedDRA coding and adherence to term selection guidelines.
- Maintained knowledge of drug safety profiles and labeling documents (SPC, CDS, IB).
- Complied with global regulatory frameworks including ICH, GVP, FDA, CIOMS, EU PV legislation, and GDPR.
Analyst
EClerx Services
08.2018 - 12.2019
- Provided real-time support to field technicians for cable, internet, and telephone services
- Monitored and addressed customer feedback through post-service surveys (Voice of the Customer)
Education
Master of Science - Biochemistry
Panjab University
Chandigarh, India 04.2001 -
Bachelor of Science - Biochemistry
Panjab University
Chandigarh, India 04.2001 -
Skills
Pharmacovigilance & Drug Safety
Quality & Compliance
Regulatory Knowledge
Documentation & Analysis
Communication & Collaboration
Timeline
Drug Safety Associate II
PAREXEL International
04.2022 - Current
Drug Safety Associate I
PAREXEL International
12.2019 - 04.2022
Analyst
EClerx Services
08.2018 - 12.2019
Master of Science - Biochemistry
Panjab University
04.2001 -
Bachelor of Science - Biochemistry
Panjab University
04.2001 -
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