Medical Reviewer
5 months ago
Overview:
THE ROLE:
The Medical Reviewer is a dynamic position which combines the medical case assessment capabilities of an advanced healthcare professional with exceptional communication skills to support the Gloal Consumer Safety department in relaying findings/conclusions and recommendations in response to global adverse event matters and health or product inquiries.
HOW YOU WOULD CONTRIBUTE:
- Conducts comprehensive medical assessments on AE cases received globally and communicates findings, conclusions, and/or recommendations
- Organizes pertinent medical research for collaborative projects including literature publications and internal product safety reviews
- Helps create global employee scripting and training regarding health-related complaints or questions
- Assists with literature responses/rebuttals
- Assists with data trend reviews and recommendations
- Assists with label changes, reviews, and recommendations
- Helps with consumer responses and Q&As
- Assists with complaint risk analyses and CAPA collaboration
- Assists in monitoring, reviewing, and summarizing global regulatory changes related to pharmacovigilance.
Qualifications:
SKILLS AND BACKGROUND REQUIRED TO BE SUCCESSFUL:
**Skills**:
- Excellent written and verbal communication skills in addition to the ability to effectively relay information to diverse medical/scientific or regulatory audiences as well as consumers
- Efficiently search and interpret research data from peer reviewed literature
**Experience**:
- 3 years experience with direct patient care (post-graduate/as licensed healthcare professional), comprehensive case review consulting, principle research investigator, and/or comparable experience.
**Education**:
- Graduate level health care degree: Naturopathic Medical Doctor (ND/NMD), MD (Allopathic) Medical Doctor or DO (Doctor of Osteopathic Medicine), PA (Physician’s Assistant), or NP (Nurse Practitioner) with regional proficiency equivalence
- Currently Licensed in one of the fields described above with relevant experience/expertise in drug safety, nutrition and/or botanical science
PREFERRED QUALIFICATIONS:
- Experience with safety databases, clinical trials, and/or bio/medical laboratory research and/or regulatory science/regulatory affairs
- Microsoft Excel and Word proficiency as well as Adobe Acrobat proficiency
- Professional experience in integrative health care setting (incorporating alternative or complementary health care options with conventional therapies)
- Multi-disciplinary clinical practice experience
- Peer-reviewed publication
- Bachelor’s degree or work experience in nutritional science, biostatistics, public health, or other relevant area of emphasis (in addition to terminal degree)
SUPERVISORY RESPONSIBILITIES: (Share supervisory duties, if applicable)
None
PHYSICAL DEMANDS: In general, the following physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job.
Light: Office work, some lifting, considerable walking
WORK ENVIRONMENT: In general, the following conditions of the work environment are representative of those that an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job within the environment.
- The office is clean, orderly, properly lighted and ventilated
- Noise levels are considered low to moderate
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