Job Title: Patient Safety Agreement Management - 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 lead the end-to-end lifecycle management of Pharmacovigilance Agreements (PVAs). You will be responsible for preparing, negotiating, and managing PVAs, ensuring compliance, and acting as a key point of contact between internal teams and external business partners. This role involves overseeing the safety agreement monitoring process, managing incidents, and contributing to audits and inspections while fostering continuous improvement within the pharmacovigilance function.
Key Responsibilities:
Pharmacovigilance Agreement (PVA) Management:
Lead the preparation, negotiation, and conclusion of PVAs, amendments, and terminations.
Oversee the lifecycle management of PVAs, ensuring compliance with global safety regulations.
Safety Agreement Monitoring:
Manage and monitor safety agreement activities to ensure compliance with contractual and regulatory requirements.
Develop and maintain systems for tracking non-conformance and regulatory compliance.
Cross-Functional Collaboration:
Act as the primary point of contact between internal teams and external business partners.
Lead regular and ad hoc meetings with business partners to address and resolve issues related to pharmacovigilance activities.
Process Development & Documentation:
Lead the development of process-related documentation to ensure compliance with pharmacovigilance standards.
Support process improvement initiatives and identify opportunities to enhance operational efficiency.
Incident Management:
Handle incidents, Corrective and Preventive Actions (CAPAs), and liaise with stakeholders to resolve any issues.
Ensure effective tracking and resolution of any issues related to regulatory or contractual non-compliance.
Audit & Inspection Support:
Actively support PV audits and inspections related to PVAs.
Work with QA/Compliance teams to ensure the success of partner audits and inspections.
Mentorship and Leadership:
Mentor and provide guidance to new staff on pharmacovigilance processes and procedures.
Provide hands-on leadership and support cross-functional teams to ensure timely project delivery.
Regulatory Knowledge:
Stay current with relevant regulatory guidance and standards (e.g., FDA, ICH, EMEA, PMDA).
Contribute to the development and standardization of internal processes and procedures.
What We Expect from You:
Basic Qualifications:
Doctorate degree OR
Master’s degree with 4 to 6 years of relevant experience
OR
Bachelor’s degree with 6 to 8 years of relevant experience
OR
Diploma with 10 to 12 years of relevant experience
Skills and Competencies:
Excellent communication skills (written and verbal) and proficiency in English.
Strong technical competency with a keen attention to detail.
Proactive and effective time management skills.
Expertise in pharmacovigilance systems and related processes.
Strong negotiation and conflict management skills.
Ability to lead teams and manage cross-functional projects.
Organizational and problem-solving abilities.
Deep understanding of regulations governing the pharmaceutical industry and pharmacovigilance practices.
Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint).
What Amgen Offers:
At Amgen, we prioritize your professional growth and personal well-being. We offer competitive Total Rewards Plans aligned with industry standards and support you every step of the way through your career journey.
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