Safety Monitor II Pharmacovigilance

Review and evaluate AEs and SAEs; perform first-line clinical assessment

Prepare SAE narratives and collect follow-up safety information

Monitor and report safety data from trials, RWE, spontaneous reports, and literature

Support DSMB / Safety Review Committee activities

Ensure timely regulatory safety submissions (FDA, EMA, etc.)

Maintain and reconcile safety databases

Perform MedDRA and WHO Drug coding

Contribute to SaMPs, protocols, SOPs, and CRFs

Ensure compliance with GCP, GVP, and global regulations

Participate in audits and quality improvement initiatives

Bachelor’s degree in Pharmacology, Nursing, Life Sciences, or related field

1–2 years experience in Pharmacovigilance / Clinical Safety preferred

Freshers considered with relevant internships, projects, or PV certifications

Strong knowledge of GCP, GVP, and GxP principles

Good clinical judgment and scientific writing skills

High attention to detail and strong organizational skills

Effective communication and teamwork in global settings

Global CRO with strong scientific reputation

Exposure to international trials and regulatory work

Learning-focused culture and career growth opportunities