Job Title: Patient Safety Agreement Management (PSAM) - Manager
Location: Hyderabad, India
Work Location Type: On-site
Date Posted: February 1, 2025
Category: Safety
Job Summary:
As a Patient Safety Agreement Management (PSAM) Manager at Amgen, you will be responsible for the management of Pharmacovigilance Agreements (PVAs), including their preparation, negotiation, execution, and ongoing monitoring to ensure compliance with global regulatory requirements. This role demands strong interpersonal skills, excellent communication abilities, and the capacity to handle multiple priorities under strict deadlines.
Key Responsibilities:
PV Agreement Management:
Lead the preparation, negotiation, and conclusion of Pharmacovigilance Agreements (PVAs), including amendments and terminations.
Act as the key contact for the end-to-end lifecycle management of PVAs with both internal and external stakeholders.
Safety Agreement Monitoring:
Monitor safety agreements and ensure compliance with all relevant regulations.
Develop and implement systems to track non-conformance and ensure proper action is taken when needed.
Cross-Functional Collaboration:
Lead meetings with Business Partners to address and resolve issues related to pharmacovigilance activities.
Provide support during audits and inspections related to PVAs, ensuring compliance with standards like FDA, ICH, and EMEA PMDA.
Training and Mentorship:
Mentor new staff members and assist in the training process related to pharmacovigilance agreements.
Process Improvement:
Proactively contribute to efficiency improvements in pharmacovigilance processes and mitigate risks of non-compliance.
Identify and implement opportunities to improve operational efficiencies within the department.
Documentation and Compliance:
Ensure that process documentation is developed and maintained to comply with regulatory standards.
Regularly review and update process documentation to maintain compliance.
What We Expect from You:
Basic Qualifications:
Doctorate degree OR
Master’s degree and 4-6 years of directly related experience OR
Bachelor’s degree and 6-8 years of directly related experience OR
Diploma and 10-12 years of directly related experience
Skills and Competencies:
Excellent command of English (written and spoken)
Proactive communication and strong interpersonal skills
Technical competency and attention to detail
Strong time management, planning, and problem-solving abilities
Ability to negotiate, manage conflict, and lead teams
Organizational skills and the ability to manage multiple priorities
Customer-focused with a strong ability to manage stakeholder relationships
Proficiency in Microsoft Suite (Outlook, Word, Excel, PowerPoint)
In-depth knowledge of Regulatory and Safety functions, including pharmacovigilance systems and global regulations governing the pharmaceutical industry
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