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Patient Safety Agreement Management - Senior Associate

1-9 years
Not Disclosed
10 Feb. 6, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Patient Safety Agreement Management - Senior Associate

📍 Location: India - Hyderabad
💼 Job ID: R-205957
🕒 Work Location Type: On-site
📅 Date Posted: Feb. 01, 2025
🗣 Category: Safety

Job Overview:

As a Senior Associate in Patient Safety Agreement Management (PSAM) at Amgen, you'll contribute to operational excellence by ensuring compliance and overseeing key activities related to Pharmacovigilance Agreements (PVAs) with business partners. You’ll be responsible for negotiating, implementing, and maintaining these agreements, and ensuring all PV obligations are met and tracked.

Key Responsibilities:

  • PVA Management: Oversee and manage documentation, tracking, and compliance of global PV agreements.
  • Administrative Support: Assist with team mailbox management, meeting minutes, and managing PSAM SharePoint.
  • Audit/Inspection Support: Assist the GPS function during audits and inspections.
  • Process Documentation: Develop process-related documentation to maintain compliance and efficiency.
  • Mentorship: Support new staff in areas of expertise and share knowledge of regulatory standards (e.g., FDA, ICH).
  • Team Collaboration: Contribute hands-on support for cross-functional projects and deliver on schedules.

Qualifications:

  • Education:
    • Master’s degree with 1-3 years of directly related experience, or
    • Bachelor’s degree with 3-5 years of directly related experience, or
    • Diploma with 7-9 years of directly related experience.
  • Skills:
    • Strong command of the English language (written and spoken).
    • Excellent attention to detail and communication skills.
    • Strong customer focus and ability to work effectively in teams.
    • Proficient in Microsoft Suite (Outlook, Word, Excel, PowerPoint).
    • Knowledge of pharmacovigilance systems and regulatory guidelines.

What Amgen Offers:

  • Competitive salary and comprehensive total rewards plans.
  • A collaborative, innovative culture focused on advancing science to serve patients.
  • Opportunities for personal and professional growth.

Compensation & Benefits:

  • Salary: Competitive based on experience.
  • Benefits: Comprehensive benefits package, aligned with industry standards.