Associate Director – International PV

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

📋 Description

• Become a part of our Pharmacovigilance team as the Associate Director of International PV.

• Take charge of the leadership and management of the international PV office.

• Ensure adherence to international regulations, guidelines, and internal quality standards.

• Supervise a team of EU/UK QPPVs and PV personnel.

• Support the operational, financial, and client goals of the sub-department.

• Promote process excellence and efficient management of PV operational activities.

• Influence the performance of the quality system and PV operations.

• Oversee sub-department forecasting and assist in budget planning.

• Manage PV projects and customer engagements, ensuring the supervision of core PV deliverables.

• Ensure oversight of safety data exchange agreements with contractual partners.

• Manage inspection/audit strategies, readiness, and remediation of findings.

• Keep track of regulatory changes to ensure PV compliance across assigned projects.

• Lead the assigned team, establish goals, assess performance, and support promotion decisions.

• Identify opportunities for enhancement and proactively suggest solutions.

⛳️ Requirements

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

• Minimum of 6 years of experience in PV functions, including at least 1 year in a management role.

• Experience in team management.

• Comprehensive knowledge of international regulations (ICH, EU GVP Modules, UK guidelines, FDA).

• Proficient in PV Medical writing and project management skills.

• Proven capability to accurately evaluate, interpret, and present safety data, as well as apply global safety regulations.

• Demonstrated aptitude for implementing PV strategies and developing PV systems and procedures.

• Professional proficiency in English, both spoken and written.

• Exhibit strong leadership and collaboration skills by effectively guiding and aligning cross-functional teams.

• Advanced decision-making and problem-solving abilities.

• Excellent communication and leadership qualities.

🏝️ Benefits

• Opportunities for professional growth and career advancement.

• Work within an international team and environment.

• Performance-based annual bonus.

• Personal accident and business trip insurance.

• Additional health insurance coverage.

• Remote or home-based work option.

• Attractive referral policy.

• Workplace establishment allowance.

• Opportunities for team building, global meetings, and B active events.