WORK FROM HOME THERMOFISHER SCIENTIFIC HIRING PV RA MW COORDINATOR

Pharmacovigilance, Regulatory Affairs, and Medical Monitoring Coordinator

Job Title: PV RA MW Coordinator
Company: Thermo Fisher Scientific
Location: Remote, India
Job Type: Full-time
Job ID: R-01248219
Category: Clinical Research
Remote: Fully Remote

Job Description:

At Thermo Fisher Scientific, you’ll find meaningful work that positively impacts the world on a global scale. Join our mission to enable our customers to make the world healthier, cleaner, and safer. As part of our Clinical Research team, you’ll play a crucial role in managing the safety profile of new drugs in clinical trials, overseeing case-processing activities, and performing regulatory reporting and medical monitoring.

Key Responsibilities:

Provide contracted project coordination and safety support on global and domestic programs, focusing on serious and non-serious adverse events, protocol inquiries, physician assessment of diagnostics, Data and Safety Monitoring Boards, and Endpoint Adjudication Committees.
Liaise with Safety Specialists and Medical Monitors to establish effective relationships with internal team members, implement projects, prepare contractual documents, coordinate meetings, and manage all incoming safety documentation.
Coordinate the review of protocol inquiries, adverse events, diagnostics, and Data Safety Monitoring Board data, generate reports for clients, project teams, and external vendors, and track necessary data.
Represent the PPD DSMB/EAC Coordination Team at global and domestic committee meetings, coordinate logistical aspects, and assist with facilitation.
Interface with internal and external parties to prepare contractual documents, review documents for accuracy, and coordinate approvals.
Compile adjudication dossiers, coordinate/facilitate project meetings, manage project-specific training, and ensure PVG remains audit-ready.
Perform data entry, manage project expenses, oversee translations, answer hotline calls, and perform other duties as assigned.

Requirements:

High school diploma or equivalent with relevant formal academic/vocational qualification.
At least 2 years of previous experience providing the knowledge, skills, and abilities to perform the job.
Strong problem-solving skills, ability to work independently with minimal supervision, and initiative.
Ability to build strong relationships, analyze project-specific data/systems, and communicate effectively with clients and team members.
Self-motivated with excellent computer skills and attention to detail.
Flexibility to reprioritize workload and maintain a positive and professional demeanor in challenging circumstances.
Ability to maintain a good working knowledge of applicable FDA Regulations, ICH Good Clinical Practices, and PPD/Client SOPs.

Work Environment: