Medical Officer (Full-time or Part-time)

Medical Officer

India Remote Worker

The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients' success by sharing ideas openly and honestly.

Purpose

The Medical Officer position has functional responsibility for pharmacovigilance (PV), medical consulting and review activities including protocol development activities and practical aspects of clinical trial safety monitoring, particularly focused in Vaccine/Infectious Diseases.

Responsibilities
  • Managing corporate and project related activities for existing and forecasted business
  • Engage in key business development initiatives including developing independent PV services in addition to technical medical inputs for proposals, client meetings and bid defense presentations
  • Ensure alignment of strategy and execution of projects by working closely with project leadership
  • Manage safety oversight throughout the life cycle of the clinical study including evaluation, assessment and monitoring of safety events and protocol deviations
  • Evaluate adverse events and serious adverse events (SAE) including expedited reporting.
  • Review SAE narratives and other safety reports
  • Review IND/IDE safety reports (MedWatch safety reports (FDA Form 3500A), Council for International Organizations of Medical Sciences (CIOMS) safety reports, and Development Safety Update Reports (DSUR), as applicable.
  • Review processes and procedures for Medical Dictionary for Regulatory Activities (MedDRA) and WHO Drug coding
  • Review the FDA MedWatch Alerts and safety communications and recommend action for implementation by Emmes, as applicable
  • Provide medical input on safety considerations during development of protocol and associated documents
  • Advise Study sponsor and study team on protocol development, inclusion/exclusion criteria, and eligibility questions, protocol study design and halting rules, etc
  • Ensure the medical and scientific quality of documents such as clinical trial protocols, investigator's brochure, informed consent document, patient diaries, and case report forms
  • Work directly with project level staff to develop appropriate pharmacovigilance documents and project plans (Safety Monitoring Plan, Communication Plan and Training Plan)
  • Support review of safety section of clinical trial reports like annual reports and clinical study reports
  • Engage with safety oversight committees (SOC), and consult with sponsors, investigators and pharmaceutical partners
  • Participate in safety oversight committee meetings (DSMB/DMC/SMC); answering questions about safety monitoring and related procedures (e.g., review of halting rules)
  • Review SOC Charter, safety reports, and meeting minutes
  • Participate in Sponsor meetings, and investigator training meetings
  • Participate in regulatory (FDA or other) meetings and scientific review meetings
  • Interact with Pharmaceutical companies and other study partners
  • Participate in corporate process improvement and corporate quality assurance activities through Internal Quality Audit Team (IQAT) processes, SOP development, participation in internal and external audits, and professional development activities
  • Other corporate activities include annual SOP reviews, development and teaching internal Emmes training classes, participation in corporate safety meetings/activities; and other corporate PV activities
  • Other duties as assigned

Experience
  • Medical Doctor degree (MD, MBBS, MBBCh, or other equivalent) is required for the position
  • Active US Medical License
  • 10 years' total experience consisting of the following:
    • Minimum three years' experience obtained in a clinical medical setting with demonstrated clinical medicine expertise through practice experience
    • Minimum three years of pharmacovigilance experience and/or clinical trial experience, preferably in a CRO
    • Prior Infectious Disease/Vaccine clinical trials experience desired
  • Expertise in medical monitoring and serious adverse event reporting
  • Demonstrated working knowledge through experience or training in GCPs
  • Demonstrated experience with, or training in, clinical trial data collection and medical monitoring
  • FDA or regulatory experience desired
  • Ability to maintain a high degree of integrity and utilize strong interpersonal skills to carry out positive interactions with internal and external contacts
  • Excellent verbal and written communication skills
  • Ability to work and live in the US required
  • Up to 25% United States and international travel


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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

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