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Assoc Director, Pharmacovigilance & Drug Safety

Onyx Pharmaceuticals, Inc.

South San Francisco, CA
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Based in South San Francisco, California, Onyx Pharmaceuticals is an Amgen subsidiary, engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer.  At Onyx, our success begins with our employees. The progress we have made as a company reflects the talents of the individuals who have come together to develop possible new therapeutics for treating cancer.

Onyx is seeking talented and dedicated individuals of the highest caliber who are passionate about the pharmaceutical industry and driven to change the way cancer is treated.  We are proud to be an equal opportunity employer who respects individual differences and recognizes each employee as an integral member of our company.  Our culture is one where everyone can learn and develop personally and professionally.
The Assoc Dir, Pharmacovigilance & Drug Safety will function as a Global Safety Scientist (GSS) and is a core member of the Global Safety Team (GST) for assigned product(s). Working closely with the Global Safety Officer (GSO), the GSS provides pharmacovigilance expertise through contributions to GST deliverables and activities.

Applicable tasks not limited to and may vary by product(s) assigned.
Clinical trial safety
* Review study protocols, statistical analysis plans, program safety analysis plans, and other clinical study-related documents
* Review standard design of tables, figures, and listings for safety data from clinical studies

Signal detection, evaluation, and management
* Implement signal detection strategy approved by GSO
* Review adverse event data, literature, and other Safety-relevant data for the purpose of signal detection

Risk management and minimization (incl. post-approval commitments)
* Provide safety contents for risk management plans
* Develop or update strategy and content for regional risk management plans

Periodic (aggregate) safety reporting
* Manage report submission schedule
* Author or provide content for periodic safety reports; e.g., development safety update report (DSUR), periodic update safety report (PSUR) / periodic benefit risk evaluation report (PBRER)

Activities related to new drug applications and other regulatory filings
* Provide safety contents for filings

* Contribute to implementation of Corrective Action and Preventive Action (CAPA) for assigned products

Partnerships and integration activities
* Obtain non-ICSR safety information from licensing partners for periodic safety reports
* Review safety documents prepared by licensing partners

Quality control
* Perform quality control checks for deliverables of the Global Safety Team

- Doctorate degree and 2 years of directly related experience
- Master’s degree and 6 years of directly related experience
- Bachelor’s degree and 8 years of directly related experience
- Associate’s degree and 10 years of directly related experience
- High school diploma / GED and 12 years of directly related experience

* 4+ years Drug safety experience in a biotech/pharmaceutical setting
* Clinical/medical research experience
* Processes and regulations for pharmacovigilance and risk management
* Drug development and lifecycle management
* Safety data capture in clinical development and post-market settings
* Safety database structure and conventions
* MedDRA and other dictionaries used in pharmacovigilance
* Methods of qualitative and quantitative safety data analysis
* Product and disease state knowledge
* General medicine, epidemiology, physiology, and pharmacology
* Signal detection and evaluation
* Aggregate data analysis
* Good clinical and scientific judgment
* Application of medical concepts and terminology
* Document writing and source document review
* Data interpretation and synthesis
* Basic skills in application of statistical and epidemiological methods to pharmacovigilance
* Ability to convey complex, scientific data in an understandable way


Amgen is an Equal Opportunity/Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.


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