Manager, Local Pharmacovigilance

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. Ranked #21 on the Global Fortune 500, our team members are united in our responsibility to create healthier futures.

Our Shared Service Center in Lithuania is experiencing rapid growth and we have many diverse and exciting roles in Customer Service, Operations, IT, Finance and HR. Join us and make a positive impact on human and animal health.

Job Details

Responsibilities:

• Set up and manage the local pharmacovigilance system, including oversight of local PV activities.
• Local Literature Search
• Local ICSR Collection and Management
• PV Intelligence Screening
• 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)
• Implementation of additional Risk Minimization Measures
• Reviewing materials relating to local post-authorization safety studies
• Participate in PV-relevant audits and inspections
• Attend regular meetings according to project meeting schedule
• Provide monthly PV report on status of local PV system in the country/ies
• Ensure PV training of affiliate employees, service providers and Third Parties
• Close cooperation with the global PV system of the client as well as related global and local departments and functions
• Issue, review and maintain pharmacovigilance procedures (i.e. Standard Operating Procedures, Working Practices) related tothe local tasks in connection with client procedures
• Close cooperation with the respective Deputy and providing the Deputy with information on relevant current PV activities
• Identify and escalation any Medical Information requests to an appropriate team according to applicable timelines.
• 24/7 availability with the Competent Authority in the country for pharmacovigilance-related matters.
• Act as official liaison with the Competent Authority in the country for pharmacovigilance-related matters.
• Maintain oversight of local PV system to ensure compliance with national laws and regulations.
• Notify the health authority promptly of significant safety concerns, product recalls or changes in the benefit-risk profile of the products.
• Coordinate the distribution of national safety communications, such as Direct Healthcare Professional Communications.
• Ensure local pharmacovigilance system updates and validations.
• Internally, serving as point of contact for the EU-QPPV and the global PV team.
• Deputy is assuming responsibility in case of planned or unplanned absence

Qualification:

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

Experience: 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

What Cencora offers

We offer a competitive annual bonus, life insurance from Day 1, a best-in-class health insurance package, and up to 6 fully paid benefit days a year. As a Cencora employee, you have the benefit of our referral bonus scheme, our boundless learning opportunities and our global Employee Assistance Program. We have a wonderful office location in Quadrum, equipped with everything you need for a small break at work and fresh snacks at all times. Become part of our purpose-driven, multicultural team now and help us create healthier futures

Full time

Affiliated Companies:

Affiliated Companies: PharmaLex Spain S.L.U.