Medical Reviewer

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.

 Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn.

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 well 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