Work Schedule

Environmental Conditions

Job Description

Join Us as a Principal PV Coordinator in Bulgaria or Serbia – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotech's, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our expert team, you’ll have the opportunity to ensure operational excellence that makes a real difference in patient safety. As Principal Safety Admin, you'll lead project coordination and safety support on global and domestic programs with an emphasis on serious and non-serious adverse events, protocol inquiries, physician assessment of diagnostics, Data and Safety Monitoring Boards, and Endpoint Adjudication Committees. You will provide assistance to safety management in the supervision of staff and their assigned projects. You will take ownership in liaising and establishing effective relationships with the client, external vendors, and internal functional team members to implement projects, prepare contractual documents, coordinate and facilitate meetings, and accurately manage all incoming safety documentation. You will resolve complex project support issues through in-depth evaluations and data analysis.

What You’ll Do:
• Coordinates the timely review of protocol inquiries, serious and non-serious adverse events, diagnostics, DSMB/EAC data and aggregate report data; tracks all necessary data and generates reports for the client, project team and/or external vendors.
• Represents the organization's DSMB/EAC Coordination Team at global and domestic committee meetings (both via teleconference and face-to-face) alongside the client, board members, third party vendors and project team, coordinating all logistical aspects and assisting with facilitation.
• Interfaces with various internal and external parties to implement projects, prepare Confidentiality Disclosure Agreements, Letters of Intent and Member Agreements based on contractual considerations; reviewing all contractual documents for accuracy and coordinating internal/external approvals.
• Coordinates/facilitates project meetings, drafts meeting minutes, posts blinded and unblinded minutes/materials to client portals and distributes to internal and external project teams.
• Assists in the generation of QPPV compliance metrics.
• Manages project specific training and the set-up, maintenance and archival of program files, ensuring files remain audit ready and leads the efforts to identify, investigate and resolve issues.
• Identifies and redacts subject identifiers per local requirements, retrains sites and escalates reoccurrences to the organization's Data Privacy.
• Performs data entry into external datases, tracking systems and the organization's budget management system; performs system reconciliations to identify issues which could negatively impact project timelines..
• Oversees expensing/invoicing and manages translations; ensuring budget parameters are not exceeded.
• Leads global departmental and vendor initiatives, including the identification and resolution of complex project support issues.
• Act as Subject Matter Expert for various PV processes and/or systems and authors critical and non-critical quality events; identifying, developing and implementing process improvements.
• Utilizes dashboards to evaluate and analyze data to resolve complex project support issues.
• Completes periodic quality reviews, gathers information for contract proposals and bidding algorithms and provides back-up support for PV management as requested.
• Develops and delivers training / training materials for new team members, prepares departmental SOPs / WPDs and supports management with project budgetary management tasks.
• Mentors junior staff.
• Performs test calls, e-mails and faxes and confirming safety database access for the QPPV.
• Coordinates department functions.
• Supports any specific activities performed by the local office, which cannot be performed from elsewhere.

Education and Experience Requirements:
• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
• Technical positions may require a certificate
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 6 years).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:
• Demonstrates effective client management skills; ability to act as a liaison, communicating respectfully and diplomatically with all clients, management, project team members and other internal staff
• Firm knowledge of medical terminology
• Ability to effectively delegate tasks and ensure successful completion
• Ability to gain clear agreement and commitment from others through persuasion and influence
• Effective presentation skills
• Ability to provide constructive feedback and suggest improvements to the administrative process
• Ability to assist in the management of a large project and to provide work direction and training to other safety support staff working on the project
• Strong criticial thinking skills and ability to use problem-solving techniques applicable to constantly changing environments
• Ability to work independently with minimal supervision, demonstrating initative
• Ability to build strong relationships
• Ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
• Self-motivated, positive attitude with effective oral and written communication and interpersonal skills
• Excellent computer skills to include: MS Office (Word, Excel, PowerPoint, Access)
• Ability to identify and set priorities and effectively perform a variety of tasks simultaneously with strict deadlines
• Strong attention to detail and accuracy with orientation toward careful and meticulous work
• Ability to maintain a positive and professional demeanor in challenging circumstances
• Flexibility to reprioritize workload to meet changing project timelines
• Demonstrated ability to attain and maintain a good working knowledge of applicable FDA Regulations, ICH Good Clinical Practices, and the organization's/Client SOPs and WPDs for all non clinical/clinical aspects of project implementation, execution and closeout

Working Conditions and Environment:
• Work is performed in an office environment with exposure to electrical office equipment
• Potential drives to site locations and/or travel required on rare occasion
• Majority of work computer-based
• Long varied hours required on occasion

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthroughs.