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Patient Safety Agreement Management - Manager

4-12 years
Not Disclosed
10 Feb. 5, 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

Job Title: Patient Safety Agreement Management - Manager
Location: India - Hyderabad
Category: Safety
Job ID: R-205962
Work Location Type: On Site


About Amgen

Amgen is a global biotechnology leader with a mission to improve the lives of patients living with serious illnesses. Since its inception in 1980, Amgen has been at the forefront of biotechnological innovation, focusing on oncology, inflammation, general medicine, and rare diseases. As part of Amgen, you will help create life-changing medicines for people around the world, while growing in a collaborative and forward-thinking work environment.


Key Responsibilities

  • Pharmacovigilance Agreement Management: Oversee the preparation, negotiation, and management of PVAs (Pharmacovigilance Agreements) and related activities.
  • Safety Monitoring: Manage safety agreement monitoring and ensure compliance with regulatory standards.
  • Cross-Functional Collaboration: Serve as a key contact for PVA lifecycle management, supporting both internal and external partners.
  • Compliance and Documentation: Develop process documentation to ensure regulatory compliance and efficient operations.
  • Issue Resolution: Lead efforts to address issues or non-compliance with business partners and regulatory bodies.
  • Mentorship: Provide guidance to new staff and share expertise within the pharmacovigilance field.
  • Support Audits and Inspections: Actively contribute to audits and inspections related to pharmacovigilance.
  • Process Improvements: Identify and implement opportunities for operational efficiency and regulatory compliance.
  • Knowledge Sharing: Stay informed on regulatory guidelines and standards (e.g., FDA, ICH, EMEA PMDA) and mentor team members on the same.

Qualifications

  • Education:
    • Doctorate degree OR
    • Master’s degree with 4 to 6 years of related experience OR
    • Bachelor’s degree with 6 to 8 years of related experience OR
    • Diploma with 10 to 12 years of related experience.
  • Skills and Competencies:
    • Proficient in written and spoken English.
    • Excellent communication, negotiation, and problem-solving skills.
    • Strong technical and organizational capabilities.
    • Knowledge of pharmacovigilance systems and regulatory standards.
    • Proficient in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint).
    • Ability to manage multiple tasks and deadlines with strong attention to detail.

What You Can Expect

  • Professional Development: Amgen provides an environment focused on your growth and well-being, offering competitive benefits and career advancement opportunities.
  • Collaborative Culture: A diverse, inclusive workplace that supports innovation, and ethical collaboration in advancing scientific solutions for patients.