Senior Pharmacovigilance Specialist

This is a fully remote position, open to applicants in Croatia, +5 more countries.

📋 Description

• Assist in supporting both global and local Pharmacovigilance (PV) systems while ensuring adherence to international and local regulations.

• Assume additional responsibilities as a regional or local PV lead for straightforward PV systems.

• Serve as Project Manager or deputy Project Manager for designated projects.

• Conduct precise forecasting and aid in budget planning to facilitate the efficient operation of the QPPV Office.

• Revise Standard Operating Procedures (SOPs) and act as a subject matter expert for PV within assigned company processes.

• Maintain Key Performance Indicator (KPI) reports and execute core and standard PV tasks for assigned contractual partners.

• Oversee full or local Pharmacovigilance systems and projects, central pharmacovigilance activities, comprehensive case processing, Aggregate Safety Reports, Risk Management Plans, and risk mitigation activities.

• Serve as the primary contact for customers, ensuring effective communication and management of escalations across assigned projects.

• Take on the role of appointed EU QPPV or deputy EU QPPV, when applicable.

• Guarantee high-quality PV service performance within the assigned region/country and maintain timely communication with Health Authorities.

• Ensure readiness for inspections and audits and address any findings for remediation.

⛳️ Requirements

• A degree in Biology, Pharmacy, Medicine, or another life science field.

• A minimum of 4 years of experience in global Pharmacovigilance activities.

• Proficiency in English.

• Computer skills (MS Office) and experience with PV databases (experience with Veeva Vault Safety is a plus).

• Excellent organizational and time management abilities.

• Capability to work both independently and collaboratively within a team.

• Strong organizational skills, ability to prioritize, and reliable delivery on commitments.

• Exceptional communication and relationship-building skills across various functional teams.

🏝️ Benefits

• Opportunities for professional growth and career advancement.

• Work within an international team and environment.

• Performance-based bonus structure.

• Coverage for personal accident and business trip insurance.

• Additional health insurance coverage.

• Flexibility to work remotely or from home.

• Attractive referral policy rewards.

• Workplace establishment allowance for fully remote positions.

• Participation in team-building activities, global meetings, and B active events.