Patient Safety Agreement Management - Manager

4-12 years

Not Disclosed

Hyderabad

10 Feb. 17, 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:
Job ID: R-205962:
Work Location Type: On Site:
Date Posted: Feb. 01, 2025:
Category: Safety:

About Amgen:
At Amgen, we are committed to serving patients living with serious illnesses. Since 1980, we have pioneered biotech solutions for the world’s toughest diseases, focusing on Oncology, Inflammation, General Medicine, and Rare Disease. Join our collaborative, innovative team and help transform patients' lives.

What You Will Do:
In this role, you will:

Assess PV-related clauses in business agreements.
Lead the preparation, negotiation, and conclusion of Pharmacovigilance Agreements (PVAs), amendments, and terminations.
Act as the key contact point for the end-to-end lifecycle management of PVAs with internal and external partners.
Handle safety agreement monitoring activities.
Develop process-related documentation for compliance.
Lead meetings with Business Partners and resolve PV-related issues.
Manage Incidents/CAPAs with stakeholders as needed.
Monitor non-conformance and develop tracking systems.
Mentor new staff and actively support PV audits and inspections.
Share knowledge of regulatory guidance and standards (e.g., FDA, ICH, EMEA PMDA).
Contribute to cross-functional projects and deliver on schedule.
Proactively improve operational efficiencies and minimize regulatory non-compliance.
Negotiate and maintain global PVAs with business partners.

What We Expect of You:
We are seeking a self-starter with expertise in pharmacovigilance who can collaborate with internal and external teams effectively.

Basic Qualifications:

Doctorate degree, OR
Master’s degree with 4 to 6 years of directly related experience, OR
Bachelor’s degree with 6 to 8 years of directly related experience, OR
Diploma with 10 to 12 years of directly related experience.

Skills Required:

Excellent written and spoken English.
Proactive communication.
Strong technical competency and attention to detail.
Effective time management and planning.
Strong presentation, negotiation, and interpersonal skills.
Microsoft Office Suite proficiency.
Knowledge of regulatory and safety activities, compliance, and audits.

What You Can Expect from Us:
Amgen offers competitive benefits, supports your growth, and promotes a collaborative environment.

Apply Now:
Start your career with Amgen today.

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