Senior Manager Global Safety
Senior Manager Global Safety
Posted on :
20-01-2025
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1 Vacancy
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Job Description
Job Title: Senior Manager Global Safety
Job Location: Hyderabad Telangana India
Job Location Type: Onsite
Job Contract Type: Fulltime
Job Seniority Level:
Join Amgen’s Mission of Serving Patients
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 awardwinning 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.
Senior Manager Global Safety
What You Will Do
Let’s do this. Let’s change the world. In this vital role you will need to provide medical review of Individual Case Safety Reports (ICSRs) in support of safety surveillance for Amgen products. To support global individual case safety reports regulatory reporting compliance.
Basic Qualifications:
As we work to develop treatments that take care of others we also work to care for your professional and personal growth and wellbeing. 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.
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
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.
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 awardwinning 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.
Senior Manager Global Safety
What You Will Do
Let’s do this. Let’s change the world. In this vital role you will need to provide medical review of Individual Case Safety Reports (ICSRs) in support of safety surveillance for Amgen products. To support global individual case safety reports regulatory reporting compliance.
- Supervision of 110 staff in Amgen India with responsibilities supporting medical review and Pharmacovigilance Operation activities as required.
- To assure medical validity of ICSRs and provide expertise and guidance to the activities of Medical Safety Review Team (MSRT)
- To implement the medical review of ICSRs (narratives coding expectedness causality and seriousness) to ensure quality reports
- To act as a significant point of contact between Case Management and GSOs on medical content and regulatory reporting of ICSRs
- Handling direct reports on a daytoday basis and calling out topics as needed to GPS Senior Leadership.
- Complete the medical review of ICSRs (narratives coding expectedness causality and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports
- Act as MSRT product lead as assigned
- Implement ICSR case issue to Global Safety Officer (GSO) as appropriate
- Complete appropriate case followup per SOPs
- Support medical coding conventions and systematic process improvements for ICSR medical review
- Conduct reportability assessment for medical device associated events and/or product complaint associated events and review for potential product problems.
- Maintain list of expected terms in the auto label tool
- Monitor the compliance of auto label tool updates (if applicable)
- Support Quality Assurance of ICSR medical review (if applicable)
- Support and lead activities for the training on and implementation of new processes in MSRT (if applicable)
- Provide training to Amgen employees and vendor staff (if applicable) on ICSR medical review
- Mentor junior medical reviewers. As needed and applicable provide direct managerial responsibilities for medical reviewers on their functional team
- Conduct reportability assessment for medical device associated events and/or product complaint associated events and review for potential product problems.
- Support MSRT vendor lead to handle vendor activities and support vendor training in ICSR medical review (if applicable)
- Provide expertise and guidance on teams for interdepartmental and crossfunctional initiatives including process improvement standards development SOP creation and metrics with regards to medical review
- Perform other duties related to the position as necessary as defined in SOPs or as requested by their supervisor
- Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
- Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
Basic Qualifications:
- Doctorate degree and 2 years of relevant experience OR
- Master’s degree and 8 to 10 years of relevant experience OR
- Bachelor’s degree and 10 to 14 years of relevant experience OR
- Diploma and 14 to 18 years of relevant experience
As we work to develop treatments that take care of others we also work to care for your professional and personal growth and wellbeing. 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.
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
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.
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Employment Type
Full Time
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