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Medical Reviewer
MMS Holdings
posted 3mon ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- Demonstrate excellent internal and external customer service and communication skills.
- Demonstrate strong knowledge of current clinical trial and post market PV regulations (ICH, GVP, EMA, FDA, etc)
- Provide significant expertise as primary medical reviewer of individual case safety reports (ICSRs), including reportability and relationship assessment
- Expert adverse event coding, data retrieval, and analysis activities in clinical trials and post market
- Knowledge of MedDRA, including MVAT, and WHO Drug including CAT
- Aggregate case analysis, safety summaries and safety signal detection
- Lead safety activities on assigned product(s) that may include interactions with other functional groups in the company
- Responsible for strategies in pre and post marketing risk management, as we'll as keeping abreast of pharmacovigilance methods and trends in published literature
- Responsible for strategies in monitoring and analysis of cumulative safety information
- Responsible for developing medical plans (safety surveillance plan) and processes to monitor safety in clinical trials and post marketing environment
- Provide medical input for clinical documents such as safety sections of NDA submissions, Protocols, Investigational Brochures, Safety Aggregate Reports (DSUR, PBRER)
- Guide and coordinate preparation of ad-hoc benefit-risk assessment documents
- Provide medical input for safety updates of company core data sheet and local product labels, as per regulatory requirements
- Guide regulatory strategy and preparation of data related safety to regulatory authorities and advisory committees
- Mentor new medical reviewers; creates narrative training exercises
- Interact directly and independently with client to coordinate all facets of projects; competent communicator
- Conduct thorough self-review of deliverables prior to release to client; serves as high level reviewer for others
- Travel to client sites as necessary
- Demonstrate extensive knowledge of departmental processes
- Take initiative to suggest and implement departmental process improvements
- Lead some projects with minimal management oversight, including complex projects with multiple team members and independent coordination with the client
Minimum Requirements
- Medical degree required (MBBS/MD)
- 4+ years experience in signal detection activities, Literature review and aggregate data review
- Excellent scientific writing skills
- Strong understanding of clinical data
- Proficiency with MS Office applications
- Expert knowledge of current regulatory practices and domestic and international regulations
- Must have a minimum of 1-year clinical experience and/or research experience
- Experience in the pharmaceutical or CRO industry
- Excellent knowledge of medical terminology, clinical pharmacology and regulatory guidelines (ICH, FDA, EMA)
- Proficiency in safety databases and pharmacovigilance software
- Ability to work independently and manage priorities
- Strong communication skills, both written and verbal
Employment Type: Full Time, Permanent
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based on 9 employees
Flexible timing
Monday to Friday
No travel
Day Shift
MMS Holdings Benefits
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