Patient Safety Agreement Management - Manager

4-12 years

Not Disclosed

Hyderabad

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-205963
Work Location Type: On Site

About Amgen

Amgen is a leading biotechnology company with a mission to serve patients living with serious illnesses. With a rich history since 1980, Amgen has been at the forefront of groundbreaking research and innovative treatments in areas such as oncology, inflammation, general medicine, and rare diseases. As a member of the Amgen team, you’ll contribute to transforming lives through the development and delivery of life-saving medications.

Key Responsibilities

Pharmacovigilance Agreements (PVAs): Lead the preparation, negotiation, and management of PVAs, including amendments and terminations, with both internal and external partners.
Safety Agreement Monitoring: Oversee safety agreement monitoring activities, ensuring compliance with regulatory standards.
Business Partner Support: Serve as the primary contact for PVA lifecycle management and resolve issues with business partners.
Documentation and Compliance: Develop and maintain process documentation to ensure compliance with regulations and internal policies.
Audits and Inspections: Actively support pharmacovigilance audits and inspections, liaising with QA/Compliance teams.
Continuous Improvement: Identify and implement opportunities to enhance operational efficiency and minimize risks related to regulatory and contractual non-compliance.
Training and Mentorship: Mentor new staff in pharmacovigilance areas and share knowledge of regulatory guidance (e.g., FDA, ICH, EMEA).
Collaboration: Work with cross-functional teams to contribute to projects, ensuring timely and successful delivery.
Regulatory Knowledge: Stay updated on global regulations governing the pharmaceutical industry and pharmacovigilance practices.

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:
- Strong command of English (written and spoken).
- Excellent communication, negotiation, and interpersonal skills.
- Strong technical and organizational competency, with attention to detail.
- Time management and problem-solving capabilities.
- Proficient in Microsoft Suite (Outlook, Word, Excel, PowerPoint).
- Knowledge of pharmacovigilance systems and regulatory standards in the pharmaceutical industry.

What You Can Expect

Growth and Development: Amgen offers a supportive environment focused on personal and professional development.
Work-Life Balance: A competitive benefits package and collaborative culture help you maintain a healthy work-life balance.
Inclusive Culture: Join a diverse team committed to serving patients and advancing scientific innovation.

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Patient Safety Agreement Management - Manager

Job Description

About Amgen

Key Responsibilities

Qualifications

What You Can Expect

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