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Pv Ra Mw Coordinator

1-2 years
Not Disclosed
10 Sept. 23, 2024
Job Description
Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Work Schedule

Standard: Monday to Friday
Environmental Conditions: Office


Job Description

Purpose:
To provide project coordination and safety support for global and domestic programs, focusing on adverse events, protocol inquiries, physician diagnostics, Data and Safety Monitoring Boards, and Endpoint Adjudication Committees. Collaborates with Safety Specialists and Medical Monitors to foster effective relationships with internal teams, manage projects, prepare contractual documents, coordinate meetings, and oversee incoming safety documentation.


Essential Functions:

  • Safety Document Coordination:
    Assist in the timely and accurate review of safety and regulatory documents upon receipt.

  • Document Quality Management:
    Ensure high-quality document supervision, ensuring proper data uploading into internal and external electronic trial master files.

  • Confidentiality Maintenance:
    Safeguard sensitive information by ensuring the redaction of Commercially Confidential Information and Personal Data for regulatory purposes.

  • License Maintenance:
    Support the management of project licenses in compliance with IT Security standards for seamless user operations.

  • Meeting Coordination:
    Organize and facilitate project meetings, promoting effective communication and teamwork.

  • Training and File Management:
    Lead project-specific training sessions and maintain program files to ensure audit readiness.

  • Client and Subject Confidentiality:
    Identify and redact confidential identifiers, providing necessary retraining and addressing recurring issues with PPD Data Privacy.

  • Data Entry and Tracking:
    Accurately enter data into various databases, including PPD’s budget management system, to maintain project timelines.

  • Expense Oversight:
    Manage expenses and translations, ensuring adherence to budgetary constraints.

  • Document Archiving:
    Assist in archiving regulatory documents and submissions to ensure smooth information flow and compliance.

  • Additional Support:
    Provide assistance for recent bids and realignment with FSP.


Qualifications:

  • Education:
    Degree in Life Sciences (preferably B. Pharma).

  • Experience:
    1-2 years in PV Case Processing activities. Experience with Argus or Aris G is preferred.

  • Availability:
    Immediate joiners are highly preferred.

  • Skills:

    • Strong problem-solving abilities.
    • Independent worker with initiative.
    • Excellent relationship-building skills.
    • Analytical skills for project data and systems.
    • Respectful and diplomatic communication with clients and teams.
    • Self-motivated with a positive attitude; effective in oral and written communication.
    • Proficient in MS Office (Word, Excel, PowerPoint, Access).
    • Strong prioritization and multitasking skills under strict deadlines.
    • High attention to detail and accuracy.
    • Professional demeanor in challenging situations.
    • Flexibility to adjust workload according to changing project timelines.
    • Knowledge of FDA Regulations, ICH Good Clinical Practices, and relevant SOPs/WPDs for project implementation and execution.