Thermo Fisher Scientific Inc. is hiring for the position of PV RA MW Coordinator. This role involves working in the Pharmacovigilance (PV), Regulatory Affairs (RA), and Medical Writing (MW) domains, focusing on ensuring compliance with global regulatory standards, supporting drug safety, and producing scientific documentation.
PV RA MW Coordinator
Job Type Full time, Remote, India
Job Description
Summarized Purpose:
Provides contracted project coordination and safety support on global and domestic programs with an emphasis 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, liaises and establishes effective relationships with internal functional team members to implement projects, prepare contractual documents, coordinate and facilitate meetings and accurately manage all incoming safety documentation.
Essential Functions:
• Provides critical support and coordination in the review of safety and regulatory publishing documents, ensuring timely and accurate processing upon receipt.
• Plays a key role in maintaining document quality by supervising safety and regulatory publishing data, ensuring flawless uploading into internal and/or external electronic trial master files.
• Takes ownership for maintaining the confidentiality and integrity of sensitive information, meticulously ensuring the redaction of Commercially Confident Information and Personal Data for regulatory publishing.
• Assists in the maintenance of licenses across projects, ensuring compliance with IT Security standards and facilitating smooth operations for users.
• Takes charge of coordinating and facilitating project meetings, ensuring effective communication and teamwork among team members.
• Demonstrates outstanding interpersonal skills by leading project-specific training, setting up and maintaining program files, and ensuring audit readiness.
• Protects subject and client confidentiality by identifying and redacting confidential identifiers according to local requirements, providing vital retraining, and raising any recurring issues to PPD Data Privacy.
• Performs accurate and efficient data entry into various databases and tracking systems, including PPD’s budget management system, ensuring project timelines are not compromised.
• Takes ownership of overseeing expenses and managing translations, ensuring adherence to budget parameters and cost-efficiency.
• Assists in the crucial task of archiving regulatory publishing documents and submissions, contributing to the flawless flow of information and compliance.
• Additional support to cover for the recent bids and realignment with FSP
Qualifications:
- Any Life Science Graduate. Preferably B. Pharma
- Should 1 -2 years of working experience in PV Case Processing related activities
- Having experience on Argus or Aris G is Preferred
- Immediate joiners are highly preferred
- 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 nonclinical/ clinical aspects of project implementation, execution and closeout
Why Join Thermo Fisher Scientific?
Thermo Fisher Scientific is a global leader in serving science, providing products and services that support a wide range of industries, including pharmaceuticals. Working at Thermo Fisher offers professional growth, exposure to innovative projects, and opportunities to make a difference in global healthcare.