Thermo Fisher Scientific Inc. is a leading global provider of scientific instruments, reagents and consumables, software, and services. The company’s mission is to enable its customers to make the world healthier, cleaner, and safer. Thermo Fisher serves various sectors including pharmaceutical and biotech, healthcare, academic, government, and industrial.Vacancy Deatils
- 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
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.
Pharmacovigilance Coordination:
- Oversaw the collection, analysis, and reporting of adverse drug reactions (ADRs) and other safety-related data, ensuring timely and accurate submissions to regulatory authorities.
- Managed the development and maintenance of safety databases, ensuring compliance with pharmacovigilance regulations and standards.
Regulatory Affairs Management:
- Coordinated the preparation and submission of regulatory documents, including Investigational New Drug (IND) applications, New Drug Applications (NDA), and Marketing Authorization Applications (MAA).
- Liaised with regulatory agencies to address inquiries, negotiate submission requirements, and ensure compliance with evolving regulations and guidelines.
Medical Writing Oversight:
- Directed the preparation of clinical study reports, regulatory submissions, and scientific publications, ensuring accuracy, clarity, and adherence to regulatory requirements and industry standards.
- Developed and reviewed medical writing deliverables, including protocols, informed consent forms, and safety narratives.
Project Coordination:
- Managed cross-functional projects involving pharmacovigilance, regulatory affairs, and medical writing, ensuring alignment with project timelines, budgets, and objectives.
- Facilitated communication between internal teams and external stakeholders to streamline processes and resolve issues.
Compliance and Quality Assurance:
- Ensured all pharmacovigilance, regulatory, and medical writing activities complied with Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GPvP), and other relevant guidelines.
- Implemented and monitored quality assurance processes to maintain high standards in documentation, reporting, and regulatory submissions.
Training and Development:
- Developed and delivered training programs for team members on pharmacovigilance practices, regulatory requirements, and medical writing standards.
- Provided guidance and support to junior staff, fostering their professional development and ensuring high-quality output.
Data Management and Analysis:
- Oversaw the integration and management of safety and regulatory data, utilizing advanced tools and systems to facilitate data analysis and reporting.
- Generated and interpreted reports on safety data trends, regulatory compliance, and project status to inform strategic decision-making.
Work Enviroment
- 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).
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