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Aggregate Safety Process, Senior Specialist

Organon
Organon
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

Job Description

Position: Aggregate Safety Process, Sr. Specialist

Overview:
As an Aggregate Safety Process Sr. Specialist, you will ensure high-quality and compliant reporting of aggregate safety reports in accordance with Pharmacovigilance (PV) regulations, ensuring the integrity of aggregate safety reports while maintaining regulatory compliance.

Key Responsibilities:

  • Perform quality review and compliance monitoring of aggregate safety reports submitted to Health Authorities and Business Partners, ensuring adherence to regulatory requirements.
  • Measure and track quality effectiveness using key performance indicators (KPIs) and other relevant metrics.
  • Extract, calculate, and conduct quality control (QC) of patient exposure data for aggregate reports.
  • Monitor the quality of aggregate safety reports to ensure internal and regulatory compliance.
  • Collaborate with internal and external stakeholders to identify, prioritize, and address quality and compliance issues, developing solutions to mitigate risks.
  • Implement emerging regulations to ensure global alignment with quality and compliance activities.
  • Assess the impact of procedural changes on quality and compliance monitoring activities, updating processes as needed.
  • Participate in critical pharmacovigilance, IT, and quality initiatives.
  • Maintain procedural documents related to quality review and compliance activities.
  • Assist with inspection readiness and preparation as required.
  • Support the review of regulatory agency responses regarding quality and compliance monitoring.
  • Develop and maintain tools for streamlining quality and compliance monitoring, implementing automation where possible.
  • Provide training and support to new team members.
  • Manage Aggregate Report operations and mailbox.
  • Contribute to continuous improvement efforts within the process.

Required Qualifications:

  • Bachelor’s or Master’s degree in life sciences, healthcare, or pharmaceutical-related fields.
  • In-depth knowledge of PV principles, systems, and regulatory requirements.
  • Strong analytical skills with a focus on quality and compliance.
  • Excellent problem-solving, conflict resolution, and critical thinking abilities.
  • Ability to work autonomously, manage competing priorities, and adapt to changing business needs.
  • Proficiency in Office 365 applications.
  • Strong written and verbal English communication skills.
  • Highly organized with attention to detail and multitasking capabilities.
  • Proficient in Microsoft Office and relevant IT tools for assigned processes.
  • Ability to collaborate effectively and build relationships in a cross-functional environment.

About Us:
Organon is a global healthcare company committed to delivering health solutions that enable individuals to live their best lives. We focus on improving the health and well-being of women and their communities, driving innovation in women’s health and biosimilars.

Employment Details:

  • Employee Status: Regular
  • Relocation: No relocation provided
  • Visa Sponsorship: Not offered
  • Travel Requirements: Must meet credentialing and vaccination requirements for applicable travel.