Job Description

India - Hyderabad

JOB ID:

R-205833

LOCATION:

India - Hyderabad

WORK LOCATION TYPE:

On Site

DATE POSTED:

Feb. 04, 2025

CATEGORY:

Safety

Join Amgen's Mission of Serving Patients

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At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission--to serve patients living with serious illnesses--drives all that we do.


Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.


Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Study Liaison Manager

What you will do

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Let's do this. Let's change the world. In this vital role you will Accountable for the development of Global Patient Safety (GPS) strategy for safety-related organized data collection in Amgen clinical trials in compliance with global regulatory requirements and Amgen compliance policies and standards.


Accountable for the review, approval, and execution of GPS safety data collection strategy across clinical programs (e.g. interventional, observational research, non-Amgen sponsored clinical research, post-trial access, expanded access, etc.).


Responsible for participating in cross-functional activities to ensure and promote compliance with pharmacovigilance data collection standards and operational consistency across clinical programs for all Amgen products.

Job Summary

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The Manager works on projects and process that ensures the strategies of the department are driven into the safety related organized data collection activities in Amgen clinical activities to ensure Amgen remains aligned with global safety legislation and requirements


Provides input to Clinical teams on the needs and timelines of safety related organized data collection to ensure these needs are met and incorporated into Amgen studies activities/programs that may generate reportable safety event information


Accountable as liaison between clinical trial and Global Patient Safety to ensure capture of all reportable safety event data generated by such programs and activities


Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness

Key Activities

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Participates in the creation and dissemination of appropriate safety reporting language in clinical trial key documents, such as study protocols, contracts, safety management plans, and investigative site study guidance documents Supports the department by being a liaison between clinical trial and Global Patient Safety to ensure capture of all reportable safety event data generated by such programs Support activities to ensure GPS input to clinical study initiatives Accountable for vendor oversight of clinical reconciliation activities to ensure reporting of all reportable safety event data within team's remit Actively participates in cross functional projects that develop and support strong cross-functional relationships and communication Develops and communicates plans/objectives to others as needed Maintains knowledge of adverse event reporting process and safety system and contribute to the development, improvement and standardization of new processes and methods Contributes to projects which involve the implementation of new processes and methods within and across Global Patient Safety Maintain functional area standard operating procedures and contribute to R&D Standards documents as applicable Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Provide input to GPS contracting groups globally Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility Performs other duties related to the position as vital as defined in Standard Operating Procedures or as requested by their supervisor.

What we expect of you

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We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of directly related experience


OR


Master's degree and 4 years of directly related experience


OR


Bachelor's degree and 6 years of directly related experience


OR


Associate's degree and 8 years of directly related experience

Or

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High school diploma / GED and 10 years of directly related experience AND


4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

Able to effectively represent ideas both verbally and in writing Sound knowledge of the global safety environment, regulations, and guidance Project and/or Process Management experience & knowledge Sound understanding of safety data capture, representation, and interpretation Sound knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery Able to apply multi-disciplinary knowledge and understanding to effectively collaborate and negotiate within function and cross-functionally Able to organize, plan and prioritize workload for the function

What you can expect of us

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As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.


In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

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As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.


Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.


We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.