Manager, Local Pharmacovigilance

Job not on LinkedIn

🔥 0 minutes ago

🇱🇻 Latvia – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

👔 Manager

👻 Ghost score 10%

infoinfo

🗣️🇱🇹 Lithuanian Required

Apply Now
Find Similar Remote Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Logo of Cencora

Cencora

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 pharmacovigilance system master file (PSMF), where applicable • Set up local organized data collection • Manage local pharmacovigilance agreements (PVAs) • Adapt and submit local PSURs/RMPs, 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 reports on the status of the local PV system in the country/countries • 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, including SOPs and working practices • Cooperate with the respective Deputy and provide information on relevant current PV activities • Identify and escalate Medical Information requests according to applicable timelines • Notify the health authority of significant safety concerns, product recalls, or benefit-risk profile changes • Coordinate distribution of national safety communications, including Direct Healthcare Professional Communications • Ensure local PV system updates and validations • Serve internally as point of contact for the EU-QPPV and global PV team • Assume responsibility as Deputy 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 • English business fluent • Local language: Latvian, Estonian and Lithuanian • 24/7 availability with the Competent Authority in the country for pharmacovigilance-related matters • Ability to act as official liaison with the Competent Authority • Knowledge of national laws and regulations applicable to pharmacovigilance

🏖️ 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 during the employment process for individuals with disabilities

Apply Now

Similar Jobs

🕒 July 29

AppXite

51 - 200

💼 Consulting

📦 Logistics

☁️ SaaS

Lead vendor integration management and onboarding for a digital marketplace platform. Collaborate with global cloud vendors to enhance AppXite's offerings.

🕒 July 15

EIT RawMaterials

51 - 200

🏭 Manufacturing

💼 Consulting

📦 Logistics

IT Service & Asset Manager ensuring reliable delivery of IT services in Europe’s raw materials sector. Responsible for vendor management and IT asset governance.

🕒 April 24

PSI CRO AG

1001 - 5000

🏥 Healthcare

💼 Consulting

📦 Logistics

Central Monitoring Manager leading risk-based monitoring in clinical studies at PSI. Overseeing data integrity and patient safety with centralized monitoring functions.