Manager, Local Pharmacovigilance

This is a fully remote position, open to applicants in Lithuania.

📋 Description

• Establish and oversee the local pharmacovigilance system, ensuring effective management of local PV activities.

• Execute local literature searches.

• Gather and manage local Individual Case Safety Reports (ICSRs).

• Conduct PV intelligence screenings.

• Maintain the local Pharmacovigilance System Master File (PSMF) as necessary.

• Implement organized local data collection processes.

• Manage local pharmacovigilance agreements.

• Modify and submit PSUR/RMP documents when applicable.

• Carry out local signal detection where necessary.

• Introduce additional risk minimization strategies.

• Review materials associated with local post-authorization safety studies.

• Engage in pharmacovigilance-related audits and inspections.

• Participate in regular project meetings.

• Deliver monthly pharmacovigilance reports detailing the status of the local PV system.

• Ensure pharmacovigilance training for affiliate staff, service providers, and third parties.

• Collaborate with the client's global pharmacovigilance system and relevant departments.

• Develop, review, and maintain pharmacovigilance procedures.

• Work with the Deputy to provide updates on current pharmacovigilance activities.

• Recognize and escalate Medical Information requests within designated timelines.

• Maintain 24/7 availability for the Competent Authority concerning PV-related issues.

• Serve as the official liaison with the Competent Authority.

• Ensure compliance of the local PV system with national laws and regulations.

• Promptly inform health authorities of significant safety concerns, product recalls, or changes in benefit-risk balance.

• Coordinate the dissemination of national safety communications.

• Ensure timely updates and validations of the local PV system.

• Act as the internal point of contact for the EU-QPPV and the global pharmacovigilance 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 discipline, or equivalent experience is required.

• Minimum of 2 years of experience in regulatory affairs, quality assurance, compliance, documentation control, or a comparable field is required.

• Certification in regulatory affairs, quality management, compliance, or auditing is preferred.

• Proficiency in business English.

• Proficiency in local languages: Latvian, Estonian, and Lithuanian.

🏝️ Benefits

• Competitive annual bonus.

• Life insurance from Day 1.

• Comprehensive health insurance package.

• Up to 6 fully paid benefit days each year.

• Referral bonus program.

• Unlimited learning opportunities.

• Global Employee Assistance Program.

• Office located in Quadrum with complimentary snacks.