Cronus Pharma ยท 3 days ago
Pharmacovigilance Manager
East Brunswick, NJ
Full-time
Onsite
Mid Level
3+ years expCronus Pharma is a fully integrated animal health pharmaceutical company specializing in Research & Development, Manufacturing, and Marketing. The Pharmacovigilance Manager will be responsible for monitoring, evaluating, and reporting adverse drug reactions while ensuring compliance with global pharmacovigilance regulations for the company's generic pharmaceutical portfolio.
Pharmaceuticals
Responsibilities
Process, evaluate, and document adverse event reports from various sources including healthcare professionals, patients, literature, and regulatory authorities
Ensure timely and accurate submission of individual case safety reports (ICSRs) to regulatory agencies per local and international requirements
Conduct case follow-up activities to obtain additional information when necessary
Prepare and submit periodic safety reports within regulatory timelines
Ensure compliance with FDA, EMA, and other regional pharmacovigilance regulations
Maintain awareness of changing global PV regulations and implement updates to procedures
Support regulatory inspections and audits related to pharmacovigilance activities
Maintain accurate and complete pharmacovigilance documentation in compliance with guidelines
Ensure data quality and integrity in safety databases
Contribute to the preparation and maintenance of SOPs and work instructions
Participate in quality assurance activities and continuous improvement initiatives
Liaise with regulatory affairs, quality assurance, medical affairs, and commercial teams
Communicate safety information to internal stakeholders effectively
Collaborate with contract manufacturing organizations and partners on safety data exchange
Support training initiatives for personnel involved in adverse event reporting
Qualification
Required
Bachelor's degree in Life Sciences, Pharmacy, Nursing, or related healthcare field
Minimum 3-5 years of experience in pharmacovigilance within the pharmaceutical industry
Experience with generic pharmaceuticals is required
Hands-on experience with safety database systems (e.g., Argus, ARISg, Oracle Empirica)
Strong knowledge of global pharmacovigilance regulations (FDA, EMA, ICH guidelines)
Proficiency in medical terminology and adverse event coding (MedDRA, WHO-DD)
Experience with electronic reporting systems (FDA FAERS, EudraVigilance, VigiBase)
Proficient in Microsoft Office Suite
Excellent attention to detail and analytical skills
Strong written and verbal communication abilities
Ability to work independently and manage multiple priorities
Problem-solving skills and scientific judgment
Time management skills to meet strict regulatory deadlines
Team player with collaborative mindset
Preferred
Advanced degree (PharmD, MS, MPH) preferred
Benefits
401(k)
401(k) matching
Dental insurance
Health insurance
Paid time off
Relocation assistance
Company
Cronus Pharma
Cronus Pharma is an integrated R&D, Manufacturing, and Marketing animal health pharmaceutical company headquartered in East Brunswick, NJ.
11-50 employees
H1B Sponsorship
Cronus Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2023 (1)
2022 (4)
2020 (2)
Funding
Current Stage
Early StageCompany data provided by crunchbase