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Drug Safety Specialist

1+ 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

Position: Senior Pharmacovigilance Specialist
Company: Organon

Application Note: Please submit your CV in English. Fluency in Spanish and Portuguese is required.

About Organon:

Organon is a global healthcare leader focused on health solutions that make a positive impact in the lives of women, their families, and communities. As a $6.5 billion healthcare company, we are committed to expanding women's health solutions, access to biosimilars, and trusted healthcare products across the globe. We envision a healthier tomorrow for women everywhere.

Role Overview:

Organon seeks a Senior Pharmacovigilance (PV) Specialist to manage adverse event case processes, ensure regulatory compliance, and support patient safety initiatives. The role involves intake, tracking, reconciliation, and documentation of Individual Case Safety Reports (ICSRs) and other pharmacovigilance activities in line with global and local standards.

Responsibilities:

  • Case Management: Handle daily case intake, follow-up, and reconciliation activities for ICSRs as per global PV procedures and country regulations.
  • Compliance & SOPs: Execute local PV processes aligned with PV systems, SOPs, policies, and relevant legislation.
  • Documentation: Archive and manage safety-related data per company policy.
  • Audits & Inspections: Support local PV audits, inspections, and any related corrective actions (CAPAs).
  • Training & Process Improvement: Develop local procedures, train staff/vendors, identify procedural gaps, and suggest improvements for efficiency.
  • Cross-functional Support: Collaborate with local business units, providing insights for strategic decisions (e.g., clinical trials, product launches).

Qualifications:

  • Experience: At least 1 year in pharmacovigilance or regulatory affairs with knowledge of PV regulations.
  • Education: Health, life science, or medical science degree or equivalent experience.
  • Languages: Fluent in English, with proficiency in Spanish and Portuguese.
  • Skills: Strong communication, time management, and regulatory expertise.

Why Join Organon?

Join a mission-driven organization dedicated to health innovation. At Organon, we prioritize diversity, inclusion, and professional growth, ensuring an environment where all team members can thrive.

Equal Opportunity Employer:

Organon is committed to fostering a diverse and inclusive workforce. All qualified individuals are encouraged to apply, regardless of background.

Additional Information:

  • Status: Regular
  • Relocation: Not provided
  • Visa Sponsorship: Not available
  • Travel Requirements: Must meet credentialing requirements
  • Work Arrangements: Flexible

For more information and to apply, visit Organon Careers.