About Company
EMMES GROUP is an international clinical research and technology organization established in 1998, which is completely committed to advancing clinical trials through human expertise and AI. Emmes Group is renowned for its medical knowledge, including cell and gene therapy, vaccines, infectious diseases, and ophthalmology. For more details, please visit the official website of Emmes Group
Vacancy Details
- DEPARTMENT – Pharmacovigilance
- DESIGNATION – Safety Monitor
- DIVISION – Medical & Safety
- EXPERIENCE – Freshers & Experienced
What are the job responsibilities of a Safety Monitor?
- Help in the collection, identification, analysis, surveillance, management, and reporting of ADRs from clinical studies, RWE studies, spontaneous case reports, and literature
- Conduct initial assessment of SAEs.
- Analyze and evaluate safety data like adverse events, toxicities, concomitant medications, and medical conditions for the study.
- Interact directly with client, investigator site members, national and global regulatory authorities, and other study partners.
- Actively participates in Data Safety Monitoring Board (DSMB) and other safety review committees (SRC) meetings to provide safety input.
- Collaborates in project meetings to support the development of safety protocols, SaMPs, SOPs, MOPs, and related documentations.
- Handle the regulatory submission of safety data to regulatory bodies like the FDA and EMA.
- Coding of MedDRA and WHO drug for safety data to ensure data consistency and regulatory compliance.
- Help in generating and implementing designs of safety-related Case Report Forms (CRFs) and Safety Management Plans (SaMPs).
Skills Required
- Flexible working in a regulatory environment.
- Strong understanding of Good “X” Practice (GxP) principles.
- Expertise in clinical judgement and good communication abilities.
- Strong attention to detail with a multitasking personality.
- Excellent written and oral communication skills.
You must have the following qualifications to grab the job
- Bachelor’s degree in Pharmacy (B.Pharm)
- Bachelor’s degree in Nursing / Lifesciences and other relevant healthcare disciplines.
- Minimum 02 years of working experience in research or CROs.
- Proficient in safety monitoring and Pharmacovigilance.
- Fast learner and capable of working independently as well as in a collaborative environment.
What is the offered salary for this job role?
The company has not disclosed the Compensation Package details for the Safety Monitor role at Emmes Group However, Experienced candidates from pharmaceutical, Nursing, Life Sciences, and other related healthcare disciplines may expect the basic pay scale of up to INR 45,000/- per month.
Disclaimer: The salary figure mentioned is estimated from different websites like Glassdoor, AmbitionBox, etc.
Job Details
Emmes Group is looking for the position of Safety Monitor. If you are looking for a similar job role, this may prove the best opportunity for you to explore in such a professional working environment. Make sure you check out the details such as job location, work setting, and important contract information.
- Job Location – Bengaluru, Karnataka, India
- Contract Type – Full-Time
- Work Type – Onsite
- Company – Emmes Group
How to apply for Emmes Group Pharmacovigilance Safety Monitoring Job
Interested candidates who graduated in any health-related field are eligible to apply for the job role and can apply for the job by submitting the application using the direct application link mentioned below.
Direct Application Link Click Here
