Career Category

Job Description

Associate Global Safety

Group Purpose

The purpose of this role is to conduct assigned core safety activities for the local affiliate country/countries, including safety data collection, processing and distribution, under closer supervision, whilst developing expertise in full range. To work with local safety manager to provide specific safety support activities for the local business.

Job Summary

This role allows for the conduct of specific core safety activities for safety including data collection, processing and distribution within the relevant local country/countries, based on appropriate training and assigned roles within the safety database and related systems, under closer supervision of Safety Manager. To maintain compliance with local legislation and Company policies. To assist the Safety Manager in providing the full range of safety activities to support the local business, including safety training, participation in local medical teams providing safety information.

Key Activities

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

Local Safety Affiliate Activities (For local country or countries)
- Maintains own current knowledge of and compliance with local safety regulations for local country or countries
- Ensures that local safety activities are documented and filed or archived in line with Amgen /GRAAS policies and procedures
-Assists in the training on adverse event reporting obligations for local customer-facing staff and others required by national practice or Company policy
- Assists local Safety team with preparations for audits & inspections of safety operations
• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
• Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor

Core Safety Affiliate Responsibilities:
- Performs timely & accurate local processing steps for all adverse events reported to the local affiliate, from all sources, to enable entry into the Global Safety Database
- Assists in safety screening of local medical literature
- Timely submission of all reportable adverse drug reaction reports & the distribution of periodic safety reports or urgent safety communications, as required by local regulations and Amgen procedures
- Facilitates exchange of adverse event information with functional service providers or business partners, in line with specific agreements or procedures
- Supports intake of product complaints, in countries where local safety is designated 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 reports

-Develops, updates and implements local SOPs to ensure compliance with global PV procedures and national requirements.

- Participates in resolution of local issues that occur, through CAPAs and related activities
-Ensures local quality assurance measures to maintain inspection readiness of local safety function

Therapeutic Area Safety Support:
- Escalates product safety issues to local Safety Manager
- Develops expertise in one or more product or product classes
- Maintains awareness of current prescribing information (e.g. SmPC), investigator brochures and risk management plans to support product safety activities

With support of Safety Manager and information from Therapeutic Safety Teams:
• Represents Safety in local Medical meetings to discuss product safety issues
• Provides responses to internal and externally sourced safety questions
• Provides product safety training to commercial or medical colleagues
• Assists the Safety Manager to support the local implementation of risk minimisation activities associated with approved risk management plans

Knowledge and Skills

• Evolving working knowledge of Amgen's policies, procedures and systems
• Growing understanding of legislation which applies to safety practices locally
• Computer literacy with some knowledge of database use
• Awareness of local data privacy requirements
• Understanding of relevant medical & safety terminology
• Proactive in seeking assistance in unfamiliar situations

Education & Experience

• Bachelor’s degree
• Professional qualification as a health care professional (doctor, pharmacist, nurse, vet ) or doctoral degree(Preferred)
• Experience in biotech/pharma industry, clinically based or regulatory agency role(Preferred)