Thermo Fisher Scientific Inc is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of 13 billion USD, we have approximately 39,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through three premier brands, Thermo Scientific, Fisher Scientific and Unity™ Lab Services, which offer a unique combination of innovative technologies, convenient purchasing options and a single solution for laboratory operations management.
Post : PV COORDINATOR - FSP
Job Description
• 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 databses, tracking systems and the organization's budget management system; performs system reconciliations to identify issues which may negatively 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.
Candidate Profile
• Graduation in any Life Science degree is preferred
• 1+ Years of experience in Pharmacovigilance Case processing is required
• Having experience in Argus database is Manade
Knowledge, Skills and Abilities
• Strong problem-solving skills
• Ability to work independently with minimal supervision, demonstrating initiative
• 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
Additional Information
Experience : 1+ Years of experience
Qualification : Graduation in any Life Science degree
Location : Hyderabad, Andhra Pradesh
Industry Type : Clinical research
End Date : 15th September 2026
PV COORDINATOR : Apply Online
See All B.Pharm Alerts M.Pharm Alerts M.Sc Alerts Andhra Pradesh Alerts
See All Other Jobs in our Database
Subscribe to Pharmatutor Job Alerts by Email
