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Hello,
This is Subhash from (link removed)C, please find the below opening with one of our clients in the USA and try to share your resume to subhash@intellectt.com or call 732 696 7097.

Role: Medical Reviewer/Safety Reviewer
Location: Columbus, OH

Responsibilities:

• Collecting, assessing and processing adverse event information in a compliant and timely manner in order to meet applicable regulatory requirements.
• Coding cases using appropriate dictionary, searching and inputting data in electronic databases.
• Generating, tracking and resolving adverse event follow-up/distribution correspondence; managing adverse event reports from initial cases and follow-up.Assisting in the completion of MSS related analyses, reports, and/or projects as assigned, e.g., ingredient and finished product assessments and/or medical safety assessments.
• Presenting MSS related analyses, reports, and/or assessments orally and/or in writing within the department.
• Researching, organizing and assimilating clinical, safety, and/or toxicology information to support medical safety assessments, clinical study related safety reports, safety fact sheets and chemical approvals.
• Assisting in the generation of medical justification content reviews/templates for MSS.
• Assisting in the evaluation and establishment of nutrient specifications (minimum and maximum) during the process of formula development. Uses IOM and DRIs and other nutrient guideline data to assess product development formulations and specifications.
  

Skills:

• 1-3 years clinical and/or other related experience.
• Some industry experience is desirable.
• Basic understanding of domestic and global regulations, current clinical practices, and The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines related to product safety.
• Beginning understanding of products and their safety profiles.
• Understanding of department standard operating procedures (SOPs).
• Clinical knowledge to apply to adverse event data collection and/or medical/product assessments.
• Computer proficient (Windows, Word, Excel) and proficient in specific adverse event databases (as applicable).
• Able to present case data, medical and scientific data orally and in writing.

Education:

• Prefer a master's degree Nutrition or healthcare/science.
• Will consider a bachelor's degree with working experience.