FSP Pharmacovigilance Coordinator

JOB DESCRIPTION

Work Schedule

Environmental Conditions

Job Description

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

As part of our global team, you’ll have the opportunity to provide contracted project coordination and safety support on global and domestic programs. As a PV Coordinator, you'll focus on serious and non-serious adverse events, protocol inquiries, physician assessment of diagnostics, Data and Safety Monitoring Boards, and Endpoint Adjudication Committees. In collaboration with Safety Specialists and Medical Monitors, you will liaise and establish effective relationships with internal functional team members to implement projects, prepare contractual documents, coordinate and facilitate meetings, and accurately manage all incoming safety documentation.

What You’ll Do:
• Coordinates the timely review of protocol inquiries, serious and non-serious adverse events, diagnostics and Data Safety Monitoring Board 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 the project team, coordinating all logistical aspects and assisting with facilitation.
• Interfaces with various internal and external parties to implement projects, prepares Confidentiality Disclosure Agreements, Letters of Intent and Member Agreements based on contractual considerations; reviewing all contractual documents for accuracy and coordinating internal and external approvals.
• Compiles adjudication dossiers and creates/submits follow-up to investigative sites.
• Coordinates/facilitates project meetings, drafts meeting minutes, posts blinded and unblinded minutes/materials to client portals and distributes to internal and external project teams.
• Manages project specific training and the set-up, maintenance and archival of program files; ensuring PV remains audit ready.
• Identifies and redacts subject identifiers per local requirements, retrains sites and escalates reoccurrences to the organization's Data Privacy.
• Performs data entry into internal/external datases, tracking systems and the organization's budget management system; performs system reconciliations to identify issues which may negativley impact project timelines.
• Oversees expenses and manages translations; ensuring budget parameters are not exceeded.
• Answers incoming hotline calls, coordinates department functions and performs other duties as assigned.
• Supports any specific activities performed by the local office, which cannot be performed from elsewhere.
• Provides training to junior staff.

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 2 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:
• Strong problem solving skills
• 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
• Ability to act as a liaison and communicate respectfully and diplomatically with all clients, management, project team members and other internal staff
• 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.