To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL - https://www.linkedin.com/in/chitrank-rastogi-55119a102/), email your updated resume at Email - chitrank.rastogi@collabera.com or give me a call at (425) 523-1648. Thank you!

Job Description:
Job Roles & Responsibilities:

• As an individual contributor, with guidance from manager/team, functions to support medical safety team by collecting, assessing, processing domestic and foreign adverse events for clinical or post-marketed products in compliance with applicable regulations, guidelines, researching, assessing and summarizing nutrition and medical information as well as safety issues concerning foods or products and, by supporting clinical study teams with safety related aspects and issues.

Major 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 DRIs and other nutrient guideline data to assess product development formulations and specifications.

Education:

• Minimum Bachelor's degree with related health science background. Master’s degree preferred.

Background/Skills:

• 1-3 years clinical and/or other related experience.
• Some industry experience 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.