Safety Monitor II Pharmacovigilance
About the Role
- Key Responsibilities
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
- Qualifications
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
- Required Skills
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
- Why Emmes Group
Global CRO with strong scientific reputation
Exposure to international trials and regulatory work
Learning-focused culture and career growth opportunities
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