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Premium Employer

Amgen

Compare

2.9

based on 11 Reviews

477 Amgen Jobs

Medical Review Scientist

Amgen Inc.

2.9

based on 11 Reviews

6-8 years

Hyderabad / Secunderabad

1 vacancy

Medical Review Scientist

Amgen

posted 29d ago

Job Role Insights

Flexible timing

Key skills for the job

Medical Coding Pharmacovigilance Clinical Trials Oncology General Medicine Case Management

+ 1 more

Job Description

Medical Review Scientist

What you will do
Lets do this. Lets change the world. In this vital role you will 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

To assure medical validity of ICSRs and provide input 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 for Case Management on medical content of ICSRs

What we expect of you
We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

Doctorate degree OR

Masters degree and 4 to 6 years of relevant experience OR

Bachelors degree and 6 to 8 years of relevant experience OR

Diploma and 10 to 12 years of relevant experience

Implement the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports

Support MSRT product lead if assigned

Implement ICSR case escalation as appropriate

Implement appropriate case follow up 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.

Support MSRT Product Lead activities for the list of expected terms in the auto label tool

Support Quality Assurance of ICSR medical review (if applicable)

Support training to vendor staff (if applicable) on ICSR medical review

Mentor junior medical reviewers.

Participate in Safety Assessment Team (SAT) (if applicable)

Provide input on teams for interdepartmental and cross-functional initiatives including process improvement, standards development, Standard Operating Procedures (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

Inspection Readiness:

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

Preferred Qualifications:

Knowledge of Amgen Medical review and case management SOPs and regulatory requirements for pharmacovigilance

Clinical knowledge of therapeutic area patient populations and drug class

Proficiency in technical safety systems including the Amgen Safety database and medical coding

Knowledge of safety data capture in clinical trials and in the post marketing environments

Knowledge of clinical trials and drug development

Knowledge of Amgen products and patient population (preferred)

Employment Type: Full Time, Permanent

Read full job description

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What people at Amgen are saying

What Amgen employees are saying about work life

based on 11 employees

67%

87%

67%

50%

Flexible timing

Monday to Friday

No travel

Night Shift

View more insights

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Medical Review Scientist

Amgen Inc.

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Job Description

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