[Remote] Pharmacovigilance Assessor

Note: The job is a remote job and is open to candidates in USA. Intellectt Inc is seeking a Pharmacovigilance Specialist for a long-term remote contract position. The role involves managing adverse events within the safety system, ensuring compliance with global pharmacovigilance regulations, and supporting regulatory submissions. Responsibilities • Manage AEs and SAEs within the safety system • Review source documents and ensure accurate case entry • Evaluate cases for validity, seriousness, severity, and relatedness • Perform accurate coding of adverse events and product complaints • Conduct follow-ups and ensure timely regulatory reporting • Prepare, review, and QC case documentation and safety narratives • Assess reportability and support regulatory submissions • Respond to regulatory agency queries • Support signal detection, safety evaluations, and periodic safety reports • Maintain safety databases and support product safety improvements • Ensure compliance with global PV regulations and SOPs • Support audits, inspections, and case reconciliations • Provide pharmacovigilance training as needed • Archive safety documentation per regulatory requirements Skills • Minimum 4 years of pharmacovigilance experience • Strong working knowledge of Argus Safety Database • Understanding of clinical trials • In-depth knowledge of medical terminology • Proficiency with safety databases and MS Office Company Overview • We advance technology with purpose - empowering enterprises move confidently into the future. It was founded in 2018, and is headquartered in Iselin, New Jersey, USA, with a workforce of 1001-5000 employees. Its website is https://www.intellectt.com. Company H1B Sponsorship • Intellectt Inc has a track record of offering H1B sponsorships, with 178 in 2025, 255 in 2024, 312 in 2023, 372 in 2022, 217 in 2021, 134 in 2020. Please note that this does not guarantee sponsorship for this specific role. Apply tot his job Apply To this Job