Suresh Babu
Drug Safety Scientist II at Qinecsa | Pharmacovigilance
- Role
- Drug Safety Scientist Ii at Qinecsa Solutions
- Location
- Visakhapatnam, AP, IN
- LinkedIn followers
- 500 followers
About Suresh Babu
Relentlessly focused on patient safety and regulatory excellence, I am a Pharmacovigilance professional with 9+ years of specialized experience across global safety operations, regulatory compliance, MedDRA coding, and ICSR processing. Currently working as a Drug Safety Scientist II at Qinecsa, I bring deep expertise in managing Pharmacovigilance Agreements (PVAs), literature case handling, legal case compliance, and global stakeholder collaboration to ensure end-to-end safety data exchange.Throughout my career, I have processed over ICSRs spanning diverse therapeutic areas, ensuring 100% adherence to international regulations including FDA 21 CFR Part 11, ICH E2B (R2/R3), EMA, and MHRA. My functional knowledge of Oracle Argus and ARIS Global platforms, coupled with proficiency in triage, narrative writing, and quality review, enables me to drive robust case processing and deliver compliance-ready documentation.My academic background includes an Executive MBA from IIM Visakhapatnam and a Master’s in Pharmaceutical Analysis and Quality Assurance. I am also a certified data science professional through MITx’s Healthcare Data Science program, and have completed nine CME-accredited USFDA training modules focused on post-marketing safety surveillance, REMS, medication error prevention, and regulatory science in rare diseases.From leading audit-readiness projects to supporting cross-functional quality management systems, my commitment has always been rooted in integrity, attention to detail, and continuous improvement. I’ve worked with industry leaders such as IQVIA and Bioclinica, and currently contribute to safety excellence at Qinecsa by aligning pharmacovigilance strategies with evolving global standards.I am a registered pharmacist (PCI), a member of the International Pharmaceutical Federation (FIP), and a proud alumnus of Andhra University & IIM Visakhapatnam. I bring not just competence, but a passion for safeguarding public health through vigilant safety science.
Experience
Drug Safety Scientist Ii
Jan 2024 — Present · Mysuru, IN
Leading global PVA oversight and regulatory compliance to optimize patient safety reporting and data integrity.Oversaw global PVA lifecycle including execution, revision, and compliance tracking across safety programsEnsured safety data exchange compliance with partners and regulatory bodies, minimizing risk exposureCoordinated product complaint escalations aligned with regulatory protocols and technical evaluationsSupported GxP-aligned documentation processes and maintained updated QMS recordsCollaborated across teams to enhance workflows and deliver cross-functional pharmacovigilance excellenceManaged ICSR tracking, resource allocation, and SLA adherence for timely regulatory deliverablesPVA Management, GxP Documentation, Regulatory Compliance, QMS, ICSR Oversight
Education
Indian Institute of Management Visakhapatnam
MBA, Business Administration and Management, General
Aditya Institute of Pharmaceutical Sciences and Research
Master's degree, Pharmaceutical Analysis and Quality Assurance
2012 — 2014
St.Mary's college of Pharmaceutical Sciences
Bachelor's degree, Pharmacy
2008 — 2012
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.