Title: Contract Product Safety Specialist III – Pharmaceutical Company in NJ
Contract term: 1 year with potential extension
Work Type: 100% Remote
Critical Skills: core fit : someone with hands-on drug safety case processing experience, strong ARISg/MedDRA exposure, medical/pharmacy clinical knowledge, and the ability to communicate professionally with healthcare providers and consumers.
The company is seeking a Contract Product Safety Specialist III to support the receipt, documentation, processing, and reporting of safety information for both marketed and investigational products. This role is responsible for managing adverse event and serious adverse event reports, interacting with healthcare professionals and consumers, entering and coding safety data in the global safety database, and ensuring timely regulatory submissions to the FDA, partners, affiliates, and other health authorities.
Key Responsibilities:
- Receive, document, and process domestic and foreign adverse event and serious adverse event reports in accordance with company SOPs, work instructions, process flows, and regulatory timelines.
- Enter and code safety information accurately in the Product Safety Surveillance System, including ARISg and MedDRA coding.
- Review case information for accuracy, completeness, consistency, medical significance, labeling, listedness, and regulatory reportability.
- Conduct appropriate follow-up with healthcare professionals, consumers, and internal stakeholders to obtain required case information.
- Provide accurate product and medical information to healthcare professionals, consumers, sales representatives, and internal customers.
- Prepare, distribute, and confirm successful submission of regulatory safety reports to the FDA, co-marketing partners, affiliates, and other regulatory authorities.
- Maintain strong knowledge of Eisai products, including Company Core Data Sheets, prescribing information, and investigator brochures.
- Complete all required corporate and departmental training within required timelines.
Required Qualifications:
- Bachelor’s degree in a medical field with RN or RPh licensure, or PharmD/MD degree required.
- Minimum of 2 to 4 years of clinical medicine or pharmacy experience in the pharmaceutical industry.
- Minimum of 1 year of pharmaceutical drug safety/pharmacovigilance experience.
- Experience interviewing healthcare professionals and/or consumers to obtain medical or safety information.
- Experience providing medical or product information to healthcare professionals and consumers.
- Strong understanding of medical terminology, clinical medicine, patient care standards, and adverse event documentation.
- Computer proficiency required.
Preferred Skills and Experience:
- Experience with ARISg or another global safety database.
- MedDRA coding experience.
- Knowledge of regulatory safety reporting requirements and timelines.
- Strong attention to detail, documentation accuracy, customer service, and communication skills.
- Ability to manage safety cases in a timely, compliant, and quality-focused manner.
Pay: $35.00 - $36.00 per hour
Work Location: Remote
