Pharmacovigilance Analyst

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Cencora

WebsiteLinkedInAll Job Openings

10,000+ employees

💼 Consulting

📦 Logistics

🏥 Healthcare

Consulting • Logistics • Healthcare

Cencora is a company dedicated to improving the health and well-being of both people and animals globally. Built on the legacy of AmerisourceBergen, Cencora offers a wide range of industry-leading solutions that encompass specialty logistics, warehousing, drug research, clinical development support, and more. They provide commercialization and patient access support and offer wholesale and specialty distribution services. Cencora serves a diverse clientele, including pharmaceutical companies, physician practices, pharmacies, and health systems. The company also extends its services to animal health, managing operations and delivering products for animal pharmaceutical care. With a strong global footprint, Cencora aims to reshape healthcare delivery through innovative products and solutions, striving to create healthier futures for all.

📋 Description

• Recognize Adverse Event (AE), Adverse Drug Reaction (ADR), Adverse Drug Experience (ADE), and Medical Device Incident (MDI) information from source documents • Process Individual Case Safety Reports (ICSRs), including triage, duplicate searches, data entry, MedDRA coding, narrative writing, medical evaluation, seriousness, expectedness, causality, reportability, expedited, and periodic submissions • Perform literature reviews according to applicable SOPs and work instructions • Prepare and/or review aggregate reports, including ASRs, IRSRs, PSURs, PBRERs, PADERs, and DSURs • Perform signal detection • Prepare and/or update Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and associated documents • Act as a client contact point • Work with internal and external stakeholders to request additional information or clarification • Assist in audit preparation • File and store documents according to applicable SOPs and work instructions • Perform other tasks assigned by the Manager • May be required to be on standby/on-call

🎯 Requirements

• Bachelor's degree in life sciences, pharmacy, chemistry, biomedical sciences, engineering, quality management, or a related field, or equivalent experience required • 2+ years of experience in regulatory affairs, quality assurance, compliance, documentation control, or a related field required • Certification in regulatory affairs, quality management, compliance, or auditing preferred • May be required to be on standby/on-call

🏖️ Benefits

• Medical, dental, and vision care • Backup dependent care • Adoption assistance • Infertility coverage • Family building support • Behavioral health solutions • Paid parental leave • Paid caregiver leave • Training programs • Professional development resources • Mentorship programs • Employee resource groups • Volunteer activities • Reasonable accommodations during the employment process