The Opportunity

Global pharmaceutical company seeks a Product Safety Coordinator for a FULLY REMOTE long-term, temporary opportunity expected to last at least twelve months, possibly longer. The hourly rate is $40 (potential wiggle room), plus benefits.

Primary Responsibilities

The Product Safety Coordinator will be responsible for the receipt, triage, and preliminary evaluation of reports for both marketed and investigational products. This role involves collaborating with internal and external teams to ensure the accurate and timely processing of clinical trial, spontaneous (post-marketing), and solicited reports. Additional duties include the following:

• Receive and triage adverse event reports from all sources, including clinical trial, spontaneous, and solicited reports.
• Conduct preliminary evaluation of adverse event reports, ensuring completeness, accuracy, and adherence to regulatory guidelines.
• Perform duplicate searches, enter initial data, and assign cases to Specialists for further review.
• Assess the seriousness, expectedness, and validity of the reports.
• Prioritize tasks effectively to meet company and regulatory deadlines.
• Communicate with partners and affiliates as needed to verify the accuracy and completeness of reports.
• Distribute information to co-marketing partners, affiliate offices, and other stakeholders as requested.
  
  

Requirements

• Bachelor’s degree required, preferably in a scientific or medical discipline.
• Previous experience with data coding and retrieval using database technology.
• Seven years of relevant experience.
• Strong knowledge of medical terminology.
• Prior experience in Product Safety/Pharmacovigilance is preferred.
  
  

The Partnership – Benefits

• ABA-MEC Medical Benefit
• PEP 401k
• Paid Time Off
• Employee Assistance Program (EAP), Working Advantage (Discounts), and Financial Wellness Program (FinFit)
  
  

Frink-Hamlett Legal Solutions is an equal employment opportunity employer and all applicants will receive consideration for employment without unlawful discrimination based on race, color, creed, national origin, sex, age, disability, marital status, sexual orientation or citizenship status.