Medical Reviewer

3 weeks ago

Bengaluru, Karnataka, India MMS Holdings Inc. Full time

Are you looking to advance your career in clinical research with a company that values innovation and employee growth? MMS Holdings Inc. is a leading clinical research organization (CRO) that prides itself on its 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 maintains an industry-leading customer satisfaction rating and fosters a collaborative and inclusive work environment where employees can thrive.

Key Responsibilities:

  • Demonstrate excellent internal and external customer service and communication skills.
  • 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.

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.

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