Global Safety Medical Dir - Thousand Oaks, CA | Biospace
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Global Safety Medical Dir

Amgen

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Location:
Thousand Oaks, CA
Posted Date:
5/24/2017
Position Type:
Full time
Job Code:
R-37469
Salary:
Required Education:
Medical Doctor
Areas of Expertise Desired:

Job Description

Biosimilars are an important development for Amgen and for patients globally. The opportunity to provide patients with greater access to critical therapies furthers the Amgen mission to serve patients. Quality biosimilar development requires a new paradigm, integrating all the science and experience at Amgen developing biologics as well as our quality manufacturing while creatively and rapidly executing a streamlined and efficient data generation program to demonstrate similarity to the originator product.

Job Summary
The Global Safety Medical Director serves as the safety expert for the Biosimilar development products, establishing the strategy, direction, and priorities of pharmacovigilance activities.  The GSO is accountable for the overall safety profile and all product-related decisions and deliverables for assigned Biosimilar products in development.

KEY ACTIVITIES
Applicable tasks may vary by product(s) assigned.  The activities can be delegated to CRO or Safety Scientist while remaining accountable of the activities.
-    Clinical Trial Safety
-    Product safety profile, benefit-risk evaluation, and risk communication
-    Signal detection, evaluation, and management
-    Periodic (aggregate) safety reporting
-    Investigator's Brochure and Informed Consent Form
-    Risk management and minimization - RMP
-    Marketing applications/BLAs and other regulatory filings
-    Regulatory authority queries
-    Inspection Readiness

Requirements

Basic Qualifications
MD, DO, or equivalent degree from an accredited medical school

Preferred Qualifications (as above, and additionally):
4+ years of directly related industry pharmacovigilance experience
Product safety in the bio/pharmaceutical industry or regulatory agency
Experience in Investigational Drug development and lifecycle management
Filing/BLA experience is a plus
Experience working effectively in teams with diverse cross functional members and interests

Preferred Pharmacovigilance skills:
Clinical trial safety knowledge and experience
Safety activities of signaling and routine data review, aggregate reports (such as the DSUR),

Investigator's Brochure, Informed Consent Forms etc.
Clinical Study Reports and related activities (relevant to safety)
Risk Management Plan document generation and review
Application of medical concepts and terminology
Ability to analyze and interpret complex safety data
Ability to convey complex, scientific data in an understandable way
Basic skills in application of statistical and epidemiological methods to pharmacovigilance
Document writing skills in presenting safety data and evaluation
Regulatory agency responses and interactions