Organon

Associate Director, Pharmacovigilance Quality Assurance Auditor

Organon

full-time

Posted on:

Location Type: Hybrid

Location: Belgrade • Serbia

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Job Level

Senior

About the role

  • Schedule and conduct assigned PV audits in accordance with the global audit plan ensuring compliance with local and international guidelines and regulations.
  • Prepare audit reports and manage follow-up activities within established timelines.
  • Maintain broad-based expertise in Organon Policies, Procedures and Guidelines, local and global regulatory requirements, etc., pertinent to GVP.
  • Maintain awareness of evolving industry and regulatory trends/regulations.
  • Obtain and maintain cutting-edge knowledge, and application, for various Quality auditing topics.
  • Generate and present comprehensive presentations/summary of audit issues for effective communication to all levels, as needed.
  • Leads initiatives / drive results in various projects, as assigned, to maintain the effectiveness and efficiency of the audit program, and to ensure the audit program continues to meet company and regulatory expectations.
  • Supports the implementation and maintenance of the PV risk-based strategy, including assistance in the development of the annual audit plan and maintenance of the audit tool.
  • Reviews and provides input into the quality sections of the Pharmacovigilance System Master File (PSMF).
  • Supports regulatory inspections and external audits, when required.
  • Train and mentor junior team members.

Requirements

  • A minimum of a Bachelor’s degree in a relevant scientific field (Pharmacy, Life Sciences, etc.)
  • Fluency in written and spoken English; additional language skills a plus.
  • Minimum of ten (10) years of experience in the pharmaceutical industry or regulatory agency related to Quality Systems and Quality Assurance (e.g., clinical trial quality, pharmacovigilance, regulatory).
  • Minimum of one (1) year of experience in PV auditing with EU/FDA /global regulatory requirements.
  • Strong knowledge of EMA, FDA and ICH guidelines in GVP and proficiency in interpreting and applying regulatory requirements and guidelines.
  • Attention to detail and ability to work independently in a virtual environment.
  • Proficiency in Microsoft applications (Word, Excel, PowerPoint, Outlook).
  • Availability to travel up to 20% of time.
  • Demonstrates ability to work in partnership with others within the Company and external partners to accomplish quality goals; possesses advanced leadership skills.
  • Strong verbal skills and experienced effective writing skills.
  • Demonstrates ability to organize work efforts, prioritization of tasks and utilize appropriate resources to deliver or support work products in accordance with timelines and appropriate regulations.
  • Demonstrates skills to utilize knowledge, networks, and data to make rapid and appropriate decisions and to determine when escalation of issues is necessary.
  • Demonstrates knowledge of regulations.
Benefits
  • Flexible Work Arrangements
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
PV auditingQuality SystemsQuality Assuranceclinical trial qualitypharmacovigilanceregulatory requirementsEMA guidelinesFDA guidelinesICH guidelinesaudit tool
Soft Skills
attention to detailindependent workleadership skillsverbal communicationwriting skillsorganizational skillsprioritizationdecision makingcollaborationmentoring