採用
福利厚生
•Healthcare
•401(k)
•Equity
•Flexible Hours
•Learning
必須スキル
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
.
総閲覧数
0
応募クリック数
0
模擬応募者数
0
スクラップ
0
類似の求人
Amgenについて

Amgen
PublicA biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.
10,001+
従業員数
Thousand Oaks
本社所在地
$138B
企業価値
レビュー
3.6
10件のレビュー
ワークライフバランス
3.2
報酬
4.1
企業文化
3.4
キャリア
2.8
経営陣
3.5
65%
友人に勧める
良い点
Excellent benefits and health benefits
Good pay and compensation
Supportive management and strong leadership
改善点
Limited career growth and promotion opportunities
Work-life balance challenges and long hours
Bureaucratic processes
給与レンジ
1,244件のデータ
L2
L3
L4
L5
L6
L2 · Financial Analyst L2
0件のレポート
$94,068
年収総額
基本給
$37,627
ストック
$47,034
ボーナス
$9,407
$65,848
$122,288
面接体験
5件の面接
難易度
3.0
/ 5
期間
14-28週間
内定率
40%
体験
ポジティブ 20%
普通 80%
ネガティブ 0%
面接プロセス
1
Application Review
2
HR Screen
3
Hiring Manager Interview
4
Technical/Role-Specific Interview
5
Panel Interview
6
Offer
よくある質問
Technical Knowledge
Behavioral/STAR
Past Experience
Data Analysis/Statistics
Culture Fit
ニュース&話題
Amgen (AMGN) Laps the Stock Market: Here's Why - Yahoo Finance Singapore
Yahoo Finance Singapore
News
·
3d ago
UBS Sees Continued Upside in Amgen (AMGN), Lifts Target to $400 - Insider Monkey
Insider Monkey
News
·
3d ago
Amgen Inc. $AMGN Shares Sold by Whittier Trust Co. - MarketBeat
MarketBeat
News
·
4d ago
AE Wealth Management LLC Has $43.90 Million Holdings in Amgen Inc. $AMGN - MarketBeat
MarketBeat
News
·
4d ago



