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:
- Able to communicate and understand information with diverse groups of people.
- Able to work upright and stationary for typical working hours.
- Proficient in using standard office equipment and technology.
- Able to perform successfully under pressure while handling multiple projects.
- May require travel (Recruiter will provide more details).
