Amgen Global Safety Senior Associate - Contract Position in Bangkok, Thailand
This role demonstrates a good working knowledge of Amgen's policies, procedures and systems and practical understanding of legislation which applies to safety practices locally. Effective operation performance is based on ability to conduct core operational activities based on competent knowledge of safety terminology, database use and tools needed to handle and submit individual and period safety reports. The role also requires the ability to develop a broad understanding of how local safety supports both Amgen Global Patient Safety and the local business.
The major activities for the role are:
To conduct core safety activities including data collection, processing, distribution and regulatory submission within the relevant local country/countries, based on appropriate training and assigned roles within the safety database and related systems.
To maintain compliance with local legislation and Company policies. To assist Safety Manager to provide full range of safety activities to support the local business, including safety training and participation in local medical teams providing safety expertise and information. The ability to identify, prioritise and escalate safety issues is also very important.
Local Safety Affiliate Activities (For local country or countries)Core Safety Affiliate Operational Responsibilities
Therapeutic Area Safety Support, using expertise and with information from Product Safety Teams
Knowledge and Skills
Practical understanding of legislation which applies to safety practices locally
Computer literacy with competent knowledge of database use
Understanding of relevant medical & safety terminology
Ability to identify, prioritise and escalate safety issues
Problem solving abilities
Confident handling of core operational safety activities, when trained
Local language skills as well as excellent communication skills in English
Education & Experience (Basic)
Bachelor's degree and 2 years of directly related experience
Associate's degree and 6 years of directly related experience
Education & Experience (Preferred)
Professional qualification as a health care professional (doctor, pharmacist, nurse, vet ) or doctoral degree
Experience in biotech/pharma industry - clinically based or regulatory agency role
This is a 12 month contract with potential for an extension or conversion to a full time position.