Biomapas is a functional and full outsourcing solution provider to the global life science industry, with key expertise in Clinical Trials, Regulatory Affairs and Pharmacovigilance. With headquarters in Lithuania and offices in Switzerland, Russia, Georgia, Ukraine, Poland, Kazakhstan and Sweden, Biomapas operations are spread over 5 continents, concentrated in Europe, Russia and former CIS region.

Biomapas is looking for a Head of Pharmacovigilance Operations to lead the Pharmacovigilance Operations team, which focuses on local/regional country operations projects.

Role responsibilities:

• Line management of project/regional managers;
• Lead business expansion within repeated business contracts;
• Represent Pharmacovigilance Operations in the PV Leadership Team;
• Monitor overall compliance under projects with Pharmacovigilance Operations;
• Development and execution of the PV Operations strategy and contribution to the PV departmental strategy;
• Oversee initiatives implementation related to operational processes strengthening and “(Deputy) Local Safety Officers oversight;
• Provide and oversee reports of operational team performance and compliance;
• Participate in the development of Pharmacovigilance services, preparation, and coordination of proposals submitted to the Customers;
• Participate in Biomapas bid defense meetings organized by potential customers;
• Support Biomapas personnel in audits/inspections preparation;
• Plan Pharmacovigilance activities provided by client, estimate the resources;
• Assign PV related tasks for present employees and vendors, ensure a process for work evaluation;
• Provide Pharmacovigilance support for personnel and assist in solving PV related problems.

Role requirements:

• Academic degree in any Life Science, preferable master or higher degree;
• Fluent written and spoken English;
• Experience in Pharmacovigilance Operations team at least 7 years with team management responsibilities;
• Project management skills;
• Excellent knowledge of international regulations (ICH, EU,CIS GVP Modules);
• Ability to set-up new processes, implement strategies and adapt processes;
• Strong organization and time management skills;
• Communication and relationship building skills;
• Ability to work independently and demonstrate the initiative to find solutions, prioritize and exercise discretion.

In Biomapas, you will find a supportive work environment with a guarantee for professional and personal development, as well as a competitive salary, benefits and many more initiatives that will make your daily office life comfortable.

Please apply to cv@biomapas.com

Thank you for your attention.
Be kindly informed that only selected candidates will be contacted.

Job Type: Full Time
Job Location: Lithuania

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