Senior Specialist, Client Facing Scientific Consulting

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

📋 Description

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

• Execute local literature reviews.

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

• Conduct pharmacovigilance intelligence screening.

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

• Organize local data collection efforts.

• Administer local pharmacovigilance agreements.

• Modify and submit Periodic Safety Update Reports (PSUR) and Risk Management Plans (RMP) locally when necessary.

• Carry out local signal detection as required.

• Implement supplementary risk minimization strategies.

• Evaluate materials related to local post-authorization safety studies.

• Engage in pharmacovigilance-related audits and inspections.

• Participate in regular project meetings.

• Deliver monthly updates on the local pharmacovigilance system.

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

• Collaborate with the client’s global pharmacovigilance system and associated departments and functions.

• Draft, review, and maintain pharmacovigilance procedures.

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

• Identify and prioritize Medical Information requests within designated timelines.

• Maintain 24/7 contact with the Competent Authority regarding pharmacovigilance issues.

• Act as the official representative for the Competent Authority.

• Supervise the local pharmacovigilance system to ensure adherence to national laws and regulations.

• Alert health authorities promptly regarding significant safety issues, product recalls, or changes in benefit-risk profile.

• Coordinate the dissemination of national safety communications.

• Ensure ongoing updates and validations of the local pharmacovigilance system.

• Serve as the internal point of contact for the EU Qualified Person for Pharmacovigilance (EU-QPPV) and global pharmacovigilance team.

• Take on Deputy responsibilities during planned or unplanned absences.

⛳️ Requirements

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

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

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

• Proficient in Business English.

• Proficiency in a local language: Latvian, Estonian, or Lithuanian is required.

• Availability around the clock for the Competent Authority concerning pharmacovigilance-related matters.

• Capability to serve as the official liaison with the Competent Authority.

• Familiarity with national laws and regulations pertaining to pharmacovigilance.

🏝️ 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.