Job Title: Patient Safety Agreement Management – Senior Associate
Department: Safety
Company: Amgen
Location: Hyderabad, India
Work Location Type: On Site
Date Posted: February 1, 2025
Application Deadline: Not specified
Job ID: R-205957
Job Summary:
Amgen is seeking a Senior Associate in Patient Safety Agreement Management (PSAM) to support the negotiation, maintenance, and oversight of global pharmacovigilance agreements (PVAs) with business partners. The role includes documentation, compliance, SharePoint management, team support, and direct contributions to department projects and audits.
Key Responsibilities:
Provide administrative and operational support to the PSAM team.
Manage PSAM group mailbox and SharePoint.
Track PV obligations and non-conformance in PV agreements.
Draft, negotiate, and manage PVA amendments and terminations.
Take meeting minutes and manage documentation.
Support audits and inspections related to safety agreements.
Develop process-related documents to maintain compliance and efficiency.
Mentor new staff and participate in cross-functional project teams.
Evaluate and implement new technologies and processes.
Share regulatory knowledge (e.g., FDA, ICH, EMA, PMDA) with the team.
Basic Qualifications:
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 & Competencies:
Strong command of English (spoken and written).
Strong time management, planning, and organizational skills.
Excellent communication, presentation, and interpersonal skills.
Proficient in Microsoft Office (Outlook, Word, Excel, PowerPoint).
Knowledge of pharmacovigilance systems, regulatory requirements, and compliance.
Ability to escalate issues, solve problems, and work cross-functionally.
Experience with team building, conflict management, and global business processes.
What You Can Expect from Amgen:
Competitive compensation and Total Rewards Plans aligned with local standards.
An inclusive, science-driven culture focused on innovation and service.
Career development and supportive work environment.
Commitment to equal opportunity and reasonable accommodations for individuals with disabilities.
Application Instructions:
Apply online via careers.amgen.com.
Make a difference in patients' lives while transforming your career.
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