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트렌딩 기업

트렌딩 기업

채용

채용Amgen

Medical Review Senior Associate Scientist

Amgen

Medical Review Senior Associate Scientist

Amgen

India - Hyderabad

·

On-site

·

Full-time

·

1mo ago

복지 및 혜택

Healthcare

401(k)

Equity

Flexible Hours

Learning

필수 스킬

Medical Review

Drug Safety

Pharmacovigilance

Career Category

Safety

Job Description

Organization: Global Patient Safety

Team: PV Operations

Group Purpose: To provide medical review of individual safety case reports (ICSR) in support of safety surveillance for Amgen products. To support global individual case safety reports regulatory reporting compliance.

Job Summary:

  • To assure medical validity of ICSRs and provide input to the activities of Medical Safety Review Team (MSRT)

  • Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports.

  • To act as a point of contact for Case Management on medical content of ICSRs

Key Activites:

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

  • Execute ICSR case escalation as appropriate

  • Execute 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 Quality Assurance of ICSR medical review (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 (if applicable)

  • Perform other duties related to the position as necessary as defined in SOPs or as requested by his/her 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

Knowledge and Skills:

  • 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 Safety Database and medical coding
  • Knowledge of safety data capture in Clinical Trials and Post Marketing setting
  • Knowledge of clinical trials and drug development
  • Knowledge of Amgen products and patient population (preferred)

Education & Experience (Basic):

  • MD/DO or international equivalent and 1 year of related drug safety experience

Education & Experience (Preferred) :

  • MD/DO or international equivalent plus 3 years of relevant work

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총 조회수

0

총 지원 클릭 수

0

모의 지원자 수

0

스크랩

0

Amgen 소개

Amgen

Amgen

Public

A biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.

10,001+

직원 수

Thousand Oaks

본사 위치

$138B

기업 가치

리뷰

3.6

10개 리뷰

워라밸

3.2

보상

4.1

문화

3.4

커리어

2.8

경영진

3.5

65%

친구에게 추천

장점

Excellent benefits and health benefits

Good pay and compensation

Supportive management and strong leadership

단점

Limited career growth and promotion opportunities

Work-life balance challenges and long hours

Bureaucratic processes

연봉 정보

1,244개 데이터

L2

L3

L4

L5

L6

L2 · Financial Analyst L2

0개 리포트

$94,068

총 연봉

기본급

$37,627

주식

$47,034

보너스

$9,407

$65,848

$122,288

면접 경험

5개 면접

난이도

3.0

/ 5

소요 기간

14-28주

합격률

40%

경험

긍정 20%

보통 80%

부정 0%

면접 과정

1

Application Review

2

HR Screen

3

Hiring Manager Interview

4

Technical/Role-Specific Interview

5

Panel Interview

6

Offer

자주 나오는 질문

Technical Knowledge

Behavioral/STAR

Past Experience

Data Analysis/Statistics

Culture Fit