Shailendra Vikram Singh

I'm a Pharmacovigilance and Medical Safety Physician with 7+ years of experience spanning drug safety, medical review, and regulatory compliance across global pharmaceutical portfolios. I currently serve as Head of Safety & Efficacy and Medical Doctor within Pharmacovigilance at Sirius Pharma Consulting (Malta), where I lead CTD Module 2.4/2.5 authorship, EU Risk Management Plans, PSUR/PBRER preparation, and toxicological risk assessments for EU generic Marketing Authorisation Applications.

My career reflects a blend of clinical medicine and regulatory science — from managing ICSR medical assessments in Oracle Argus at Cognizant Technology Solutions, to leading signal detection and safety surveillance at Apcer Life Sciences, to driving process standardisation as a Medical Review SME during audits and inspections. I've elevated case quality benchmarks from under 95% to over 99%, and was ranked among the top 4 physicians in an 18-member Swiss safety operations team.

I hold an MD (Pharmacology) from RIMS, Imphal and an MBBS from Dr. Vaishampayan Memorial Government Medical College. I bring strong scientific writing, toxicological expertise (NOAEL, PDE, margin of safety), and stakeholder management to deliver audit-ready pharmacovigilance outcomes, and my work has contributed to peer-reviewed publications and national conference presentations in clinical pharmacology.

I'm now seeking a senior leadership role — as SME in Pharmacovigilance, Associate Director Medical Safety, or Global Medical Safety Physician (Lead) — with global pharmaceutical, CRO, or consulting organizations, remotely from Mumbai.