Senior Specialist, Local Pharmacovigilance

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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

• Set up and manage the local pharmacovigilance system, including oversight of local PV activities • Conduct local literature searches • Collect and manage local individual case safety reports (ICSRs) • Perform PV intelligence screening • Maintain the local PSMF where applicable • Set up local organized data collection • Manage local PV agreements • Adapt and submit PSUR/RMP documents where applicable • Perform local signal detection where applicable • Implement additional risk minimization measures • Review materials relating to local post-authorization safety studies • Participate in PV-relevant audits and inspections • Attend regular project meetings • Provide monthly PV reports on the status of the local PV system • Ensure PV training for affiliate employees, service providers and third parties • Cooperate with the client’s global PV system and related global and local departments and functions • Issue, review and maintain pharmacovigilance procedures related to local tasks • Cooperate with the respective Deputy and provide information on relevant current PV activities • Identify and escalate Medical Information requests according to applicable timelines • Maintain 24/7 availability with the country’s Competent Authority for pharmacovigilance-related matters • Act as official liaison with the country’s Competent Authority • Maintain oversight of the local PV system to ensure compliance with national laws and regulations • Promptly notify the health authority of significant safety concerns, product recalls or benefit-risk profile changes • Coordinate distribution of national safety communications • Ensure local pharmacovigilance system updates and validations • Serve internally as point of contact for the EU-QPPV and global PV team • Assume Deputy responsibilities during planned or unplanned absences

🎯 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 • Business-fluent English • Fluency in the local language

🏖️ Benefits

• Benefit offerings outside the US may vary by country and will be aligned to local market practice • Equal employment opportunity principles and non-discriminatory recruiting, training, compensation, benefits, promotions and transfers • Reasonable accommodations for individuals with disabilities during the employment process