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

• Maintain oversight of the local pharmacovigilance system to ensure compliance with national laws and regulations • Conduct local literature searches • Manage local individual case safety reports (ICSRs) • Perform pharmacovigilance intelligence screening • Maintain the local Pharmacovigilance System Master File (PSMF) • Set up local Organized Data Collection • Manage local Pharmacovigilance Agreements (PVAs) • Implement additional Risk Minimization Measures • Review materials related to local post-authorization safety • Participate in pharmacovigilance-relevant audits and inspections • Attend regular project meetings • Provide monthly pharmacovigilance reports on the status of the local system • Ensure pharmacovigilance training for affiliate employees, service providers, and third parties • Cooperate with the client's global pharmacovigilance system and related global and local departments and functions • Issue, review, and maintain pharmacovigilance procedures, including Standard Operating Procedures and Working Practices, related to local tasks and client procedures

🎯 Requirements

• University degree in Life Science • At least 3 years’ experience in pharmacovigilance • Expertise, experience, and knowledge of relevant legislative and non-legislative pharmacovigilance guidelines • Ability to train and support junior/new colleagues in daily activities • Ability to lead small projects with clearly defined scope • Ability to manage internal and external client relationships at operational/day-to-day and client team lead levels • Good written and verbal communication skills • Capability to communicate issues and propose solutions • Business-fluent English • Spanish business fluent (nice to have) • Bachelor's degree in life sciences, pharmacy, chemistry, biomedical sciences, engineering, quality management, or a related field, or equivalent experience required • 3+ 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