Safety Monitor II Emmes Group – in Bengaluru, Apply Now!
Looking for a meaningful career in clinical research? Emmes Group, a global leader in biopharmaceutical research, is hiring a Safety Monitor II in Bengaluru, India. In this pivotal role, you’ll support pharmacovigilance activities and play a key part in safeguarding patient safety during groundbreaking medical studies. If you’re passionate about drug safety
and regulatory compliance, this is your chance to contribute to cutting-edge clinical innovations.Job Details:
- Safety Monitor II at Emmes Group
- Location: Bengaluru, India
- Department: Medical & Safety
- Employment Type: Regular Full-Time
- Job ID: 2524
Emmes Group: 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, becoming 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.
Primary Purpose:
The Safety Monitor II supports Pharmacovigilance (PV) activities under general supervision. The role includes assisting senior monitors with clinical projects and may serve as the primary safety monitor for smaller projects. You will help design and execute PV-related projects in coordination with Medical Officers, Regulatory staff, and other teams. You will also ensure compliance with GCP, GVP, and other safety regulations.
Key Responsibilities for Safety Monitor II:
-
Assist in safety monitoring with Medical Monitors and project teams.
-
Review safety events and adverse drug reactions from various sources.
-
Evaluate serious adverse events (SAEs) and communicate with site staff.
-
Prepare narratives for SAEs and support regulatory submissions.
-
Maintain a database of safety events and perform reconciliations.
-
Communicate with clients, regulators, site staff, and study partners.
-
Participate in DSMB and Protocol Safety Review Team (PSRT) meetings.
-
Develop safety documents, CRFs, Safety Management Plans (SaMP), and SOPs.
-
Perform MedDRA and WHO Drug coding where applicable as Safety Monitor II.
-
Ensure accurate reporting to regulatory authorities like FDA and EMA.
-
Maintain compliance with SOPs and conduct quality control.
-
Engage in professional development and corporate safety initiatives.
Qualifications
-
Bachelor’s degree in pharmacology, nursing, or a scientific discipline preferred for Safety Monitor II.
-
At least 2 years of experience in clinical research or pharma.
-
Experience in pharmacovigilance is preferred.
-
Understanding of GxP principles and regulated environments.
-
Excellent clinical judgment and communication skills.
-
Detail-oriented, team player with good organizational skills.
Keywords: Safety Monitor II, Emmes Group, Clinical Research, Pharmacovigilance, Medical Discovery
