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Senior Specialist Pv Case Exchange

2+ years
Not Disclosed
10 Nov. 15, 2024
Job Description
Job Type: Full Time 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

Overview:
In the role of PV Case Exchange Sr. Specialist, you will play a pivotal role in maintaining compliance with industry regulations and standards. This involves ensuring timely submission of individual case safety reports (ICSRs) to Regulatory Authorities and Business Partners and supporting the organization in regulatory adherence.

Key Responsibilities:

  • Manage individual case safety report (ICSR) submissions, generate essential reports, and coordinate with internal teams and regulatory authorities.
  • Monitor the GPV Submissions mailbox to address submission queries from countries, business partners, and regulatory authorities.
  • Oversee OARS to identify and resolve issues with electronic ICSR submissions.
  • Collaborate with the BT team and other stakeholders to ensure accurate generation and transmission of reports.
  • Monitor and manage all ICSR reports for appropriate submission and required actions.
  • Facilitate manual transmission of ICSR reports from OARS to designated locations as needed.
  • Engage in discussions with Configurations and BT teams to align reporting rules and destinations with country regulations.
  • Provide support for local form submissions and ensure the proper transmission of clinical trial reports to the USFDA via eCTD.
  • Maintain acknowledgment files for eCTD submissions and assist in quality documentation related to ICSR submissions.
  • Contribute to audits and inspections, prepare monthly metrics for Case Exchange Lead, and support updates in submission processes.

Required Qualifications:

  • Bachelor’s degree in a relevant field.
  • 3-5 years of experience in ICSR submissions, with familiarity in industry regulations.
  • Proficiency in Global Safety Databases, such as ARGUS, and MS Office Suite (Word, Excel, PowerPoint).
  • Strong organizational, analytical, and communication skills, with an ability to manage deadlines and collaborate effectively across departments.

Essential Skills:
Attention to detail, effective team collaboration, problem-solving, adaptability, integrity, and time management.

About Us:
Organon is a global healthcare company dedicated to making a positive impact on women’s health and delivering a trusted portfolio of health solutions. Our commitment to diversity and inclusion is reflected in our hiring practices, welcoming applicants from diverse backgrounds.

Employment Details:

  • Employee Status: Regular
  • Relocation: Not applicable
  • Visa Sponsorship: Not provided
  • Travel Requirements: Must meet Organon’s credentialing and vaccination requirements.