Pharmacology Job at Emmes – Apply Now for Safety Monitor II!
Are you passionate about advancing clinical research and patient safety? Emmes Group, a global leader in clinical trial support, is hiring a Safety Monitor II in Bengaluru, India. Join our mission-driven team and contribute to the safety monitoring of cutting-edge therapies in cell and gene therapy, vaccines, rare diseases, and neuroscience.
- Job Posting: Safety Monitor II
- Location: India – Bengaluru
- Category: Medical & Safety
- Req ID: 2524
About The Company
Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago. It became one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry-leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.
Pharmacology Job at Emmes – Primary Purpose
The Safety Monitor II will implement Pharmacovigilance activities under general supervision in collaboration with other members of the Pharmacovigilance and Medical Monitoring (PMM) department.
Pharmacology Job at Emmes – Key Responsibilities:
- Assist in safety monitoring and pharmacovigilance activities under senior team supervision.
- Collect, assess, and report adverse drug reactions (clinical and real-world).
- Conduct first-line evaluations of serious adverse events (SAEs).
- Prepare SAE summaries for regulatory submissions, DSMB reports, and study reports.
- Ensure database maintenance and reconciliation of safety events.
- Participate in client and site communications regarding safety concerns.
- Collaborate on DSMB/Safety Review Committee activities and reports.
- Contribute to the development of Safety Management Plans (SaMPs), CRFs, SOPs, and compliance documentation.
- Perform MedDRA and WHO Drug coding.
- Maintain compliance with FDA, EMA, and international regulatory requirements.
Pharmacology Job at Emmes – Qualifications & Skills:
- Bachelor’s degree in Pharmacology, Nursing, or a related scientific discipline.
- Minimum 2 years of relevant experience in clinical research or pharmaceutical setting (CRO, SMO, pharma).
- Preferably, a background in pharmacovigilance or safety monitoring.
- Strong grasp of Good Clinical/Pharmacovigilance Practices (GCP/GVP).
- Excellent clinical judgment and communication skills.
- Detail-oriented with strong organizational and documentation abilities.
- Team player with cross-functional collaboration skills.
Why Join Emmes Group?
- Work on global research projects impacting patient lives.
- Contribute to innovative therapeutic development in neuroscience, rare diseases, and more.
- Be part of a people-driven, performance-oriented culture.
- Access professional development and learning opportunities.
Keywords: Job Posting, Safety Monitor, Clinical Research, Pharmacovigilance, Medical Monitoring, Safety events, Adverse drug reactions
