Amgen is a leading human therapeutics company in the biotechnology industry. For 35 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. Amgen pioneered the development of novel products based on advances in recombinant DNA and molecular biology and launched the biotechnology industry’s first blockbuster medicines. Today, serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness.

We are seeking a new colleague for

Safety Senior Associate
position For 2 year definite term period

Location: Zagreb, Croatia

Responsibilities:

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.

Key activities:

Core Safety Affiliate Operational Responsibilities

Timely & accurate capture, routing, translation and follow up of adverse events reported in the local country(ries) for inclusion in the Global Safety database
Assists with timely submission of all reportable adverse event reports
Assists with distribution of periodic safety reports for local and/or regional needs
Assists with the dissemination of urgent safety communications, DHPCs and DILs required by Amgen decisions or Regulatory Agency demands, according to local requirements
Assists in safety screening of local medical literature
Facilitates exchange of adverse event information with functional service providers, distributors or business partners, in line with specific agreements or procedures
Assists intake of product complaints in countries where local safety department is designated to support product quality department with this activity.

Compliance Activities:

Works with Safety Manager to maintain required standard of local operating performance and reporting compliance for AE case and periodic safety
Ensures local quality assurance measures to maintain inspection readiness of local safety function
Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor

Minimum Requirements

Life science degree in the following areas: Medical Doctor / Dentist / Pharmacist / Biochemist / Veterinarian / Specialist of clinical pharmacology
Minimum 2 years of documented experience in the field of PV or at least 2 years of experience from industry with documented education on PV terms,
Must be resident of Republic of Croatia
Fluency in English, both oral and written communications
Computer skills (MS Office programs)

Competencies

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, prioritise and escalate safety issues
Problem solving abilities

We can offer:

Member of a great team
Competitive compensation package
Chance to work in a dynamic and professional multinational organization

If you are interested in this position please send your CV with motivation letter in English via provided link.

Further information: www.amgen.com

Amgen društvo s ograničenom odgovornošću za djelatnosti posredovanja vezano uz klinička ispitivanja

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