Local Pharmacovigilance Lead – Compliance & Safety Ops

Cencora, Inc.; United States; À distance; USD 47 000 - 67 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Life insurance from Day 1

Health insurance

Up to 6 fully paid benefit days a year

Referral bonus

Learning opportunities

Employee Assistance Program

Résumé du poste

Cencora, previously known as AmerisourceBergen, is a leading global pharmaceutical solutions organization centered on improving lives. Our Shared Service Center in Lithuania is growing rapidly, with diverse roles in Customer Service, Operations, IT, Finance and HR.

This pharmacovigilance specialist role covers local PV systems, ICSR handling, PSUR/RMP support, audits, training, and compliance with national laws.

Qualifications

• 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, auditing preferred.
• English business fluent; local language Latvian, Estonian and Lithuanian is a plus.

Responsabilités

• Set up and manage the local pharmacovigilance system, including oversight of local PV activities.
• Local Literature Search and Local ICSR Collection and Management.
• PV Intelligence Screening and Local PSMF Maintenance (where applicable).
• Setting up Local Organized Data Collection; Local PVA Management; Local adaptation and submission of PSUR/RMP (where applicable).
• Local signal detection (where applicable); Implement additional Risk Minimization Measures.
• Participate in PV audits/inspections and provide monthly PV status reports.
• Ensure PV training of affiliate employees and third parties; liaise with EU-QPPV and global PV team.

Connaissances

Regulatory affairs

Quality assurance

Documentation control

Auditing

English fluent

Formation

Bachelor’s degree in life sciences, pharmacy, chemistry, biomedical sciences, engineering, quality management, or a related field

Description du poste

Cencora, previously known as AmerisourceBergen, is a leading global pharmaceutical solutions organization centered on improving lives. Our Shared Service Center in Lithuania is growing rapidly, with diverse roles in Customer Service, Operations, IT, Finance and HR.

This pharmacovigilance specialist role covers local PV systems, ICSR handling, PSUR/RMP support, audits, training, and compliance with national laws.