Shivangi Singh
Patient Safety Specialist | Parexel (Global CRO) | M.Pharm Batch Topper 91.96% | GPAT AIR 1155 | 99.2% Quality Scores | ARGUS | ICH-GCP | Oncology/CNS Drug Safety
- Role
- Patient Safety Assistant at Parexel
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Shivangi Singh
High-performing Patient Safety Specialist at Parexel International delivering 99.2% quality scores, zero critical audit findings, and 22% faster safety reporting across Oncology, CNS & Immunology trials.PROVEN IMPACT (14 months):• Processed 1,400+ adverse event cases with 99.2% QA score (vs dept avg 92%)• Streamlined safety reports to 50+ global sites, cutting turnaround 3.4→2.65 days• Improved site response 68→89%, reduced screening delays 28% across 25+ sites• Maintained 5+ clinical systems (ARGUS/CTMS/GXDB) for 28 IND/NDA trialsELITE ACADEMICS:M.Pharm Batch Topper (91.96%, Jadavpur Univ)| GPAT 2022 AIR 1155 (top 2.5% nationally)CORE EXPERTISE:Systems: ARGUS Safety | Oracle CTMS | GXDB | PMED | Rave EDC | Labcorp | Signant HealthRegulatory: ICH-GCP (E2A/E2B)| CDSCO | 21 CFR Part 11 | AE/SAE/SUSARTherapeutics: Oncology | CNS/Neurology | Immunology | CV | Phase II-IV trialsUpskilling: GCP Certified (Apr 2026)| Pharmacovigilance Specialist trackTransitioning to PRODUCT PHARMA (Sun/Dr. Reddy\'s/Cipla/Novartis) for Drug Safety Associate → Specialist roles driving clinical development & patient safety strategy.Open: Pune/Mumbai/Bangalore/Hyderabad | 6-9 LPA | Immediate availabilityConnect if hiring high-caliber PV talent ready to deliver audit-ready safety data & cross-functional impact.
Experience
Patient Safety Assistant
Jan 2025 — Present · Bengaluru, IN
Achieved 99.2% quality review score across 1,400+ adverse event cases processed in ARGUS Safety Database, maintaining zero critical audit findings & contributing to departmental GCP score of 98/100 (+7 vs benchmark)• Streamlined global safety report distribution to 50+ investigator sites (Oncology/CNS/Immunology/CV), improving turnaround 22%(3.4→2.65 days), scaling volume 75→110+ reports/mo while hitting 100% regulatory timelines• Enhanced patient screening efficiency across 25+ sites via EDC-integrated protocols (Rave/Labcorp), boosting site response 68→89%, cutting delays 28%, supporting 96% site activation on schedule• Managed 5+ clinical systems (GXDB/CTMS/PMED/ARGUS) across 28 concurrent trials, coordinating access for 160+ global stakeholders at 97% on-time rate with zero system errors• Maintained 100% documentation accuracy across 1,200+ safety documents per ICH-GCP/CDSCO, driving Internal Audit score 96/100 (vs dept avg 89), zero major deviations.
Education
Banasthali Vidyapith
Bachelor of Pharmacy
2018 — 2022
Kendriya Vidyalaya No.2 Airforce Station Tezpur
Primary School
Kendriya Vidyalaya No.2 3BRD Chandigarh
Primary School
City Montessori School
Middle School
St. Joseph Montessori School Lucknow
High School and Intermediate
Jadavpur University, Kolkata
Master of Pharmacy (Pharmacognosy), Natural Products Chemistry and Pharmacognosy
2022 — 2024
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