Emmes Group is hiring a Safety Monitor II for its India Remote / Bengaluru operations. This is an excellent opportunity for professionals with experience in pharmacovigilance, clinical safety monitoring, and adverse event management to work with a globally recognized clinical research organization supporting government and biopharma-sponsored trials.
With over 47 years of leadership in clinical research, Emmes Group is known for its expertise in cell and gene therapy, vaccines, infectious diseases, rare diseases, ophthalmology, and neuroscience. The Safety Monitor II role plays a critical part in ensuring patient safety, regulatory compliance, and high-quality safety data across interventional and non-interventional studies.
Key Responsibilities – Safety Monitor II
As a Safety Monitor II, you will be responsible for executing and supporting pharmacovigilance and medical safety activities, including:
- Performing safety monitoring activities in collaboration with Medical Monitors and project teams
- Reviewing and evaluating adverse events (AEs) and serious adverse events (SAEs)
- Collecting, assessing, monitoring, and reporting safety data from clinical trials, RWE projects, spontaneous reports, and literature
- Conducting first-line clinical evaluation of SAEs and preparing SAE narratives
- Communicating with investigator sites to obtain follow-up safety information
- Supporting DSMB/Safety Review Committee (SRC) activities and reports
- Ensuring timely submission of safety reports to regulatory authorities
- Maintaining and reconciling SAE databases
- Performing MedDRA and WHO Drug coding
- Contributing to Safety Management Plans (SaMP), protocols, SOPs, and CRFs
- Ensuring compliance with GCP, GVP, and regulatory requirements (FDA, EMA, etc.)
- Participating in audits, quality assurance activities, and continuous process improvement
Qualifications & Eligibility Criteria
To be eligible for this Safety Monitor II job in India, candidates should meet the following criteria:
Educational Qualification
- Bachelor’s degree in Pharmacology, Nursing, Life Sciences, or a related scientific discipline (mandatory)
Experience (Preferred)
- Experience in pharmacovigilance or safety monitoring
- Clinical experience in healthcare settings, pharmacy, hospitals, or clinical research centers
Freshers with the right educational background can apply if they have:
- A Bachelor’s degree in Pharmacology, Nursing, Life Sciences, or related discipline
- Strong understanding of GCP, GVP, and basic pharmacovigilance concepts
- Exposure through:
- Internship or trainee roles in pharmacovigilance
- Academic projects related to drug safety or clinical research
- Certification courses in Pharmacovigilance / Clinical Research (preferred)
However, since this is a Safety Monitor II role, candidates with 0 experience may face strong competition from those with 1–2 years of PV experience.
Required Skills
- Strong understanding of GxP principles (GCP, GVP)
- Excellent clinical judgment and scientific communication skills
- High attention to detail and strong organizational abilities
- Ability to work effectively in cross-functional and global teams
- Excellent written and verbal communication skills
- Patient-centric mindset with a focus on quality and compliance
Why Join Emmes Group?
- Work with a globally respected clinical research organization
- Exposure to international clinical trials and regulatory submissions
- Strong culture of learning, innovation, and collaboration
- Opportunity to work on high-impact therapeutic areas
- Competitive compensation and professional development support
Salary & Compensation (Indicative)
- ₹8,00,000 – ₹14,00,000 per annum (CTC)
- Salary will be commensurate with experience, qualifications, and project requirements
Job Location & Work Mode
- Location: Bengaluru, Karnataka, India
- Work Mode: Remote / Hybrid (India)
How to Apply
