Career Category

Job Description

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

We are starting the recruitment process to hire a permanent position as Sr Associate Global Safety acting as the Local contact Person for Pharmacovigilance in Portugal. This position will report to the Global Safety Sr Mgr in Iberia and will be office based in Lisbon.

The major activities for the role are:

• To conduct core safety activities including data collection, processing, distribution and regulatory submission in Portugal, 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, prioritize and escalate safety issues is also very important.

Collaborative Activities:
• Participates in global/ regional/ country safety meetings
• Provides input into Safety or cross functional initiatives, if required, to share and develop best practice.

Therapeutic Area Safety Support
• Escalates product safety issues to the Iberia Safety Sr Manager
• Develops expertise in Amgen products
• Maintains awareness of current prescribing information and risk management plans to support product safety activities

Using expertise and with information from Product Safety Teams:
• May represent Safety in local Medical meetings to discuss product safety issues
• Uses specific product expertise to contribute to responses for internal and externally sourced safety questions collaborating with Regulatory or Medical

Knowledge and skills:

• Practical understanding of legislation which applies to safety practices locally
• Computer literacy with competent knowledge of database use
• Knowledge of local data privacy requirements
• Understanding of relevant medical & safety terminology
• Ability to identify, prioritize and escalate safety issues
• Problem solving abilities
• Confident handling of core operational safety activities, when trained

Education and experience required:

• Life Sciences degree

• Around 3 to 5 years of experience in biotech/pharma industry - safety role

• Fluency in English both oral and written communications

• Understand Spanish well enough to contribute to the team work

• Computer skills MS Office programs