Global Safety Associate

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 Safety Country Lead to provide specific safety support activities for the local business.

This role allows for the conduct of specific core safety activities 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 Country Lead. To maintain compliance with local legislation and Company policies. To assist the Safety Country Lead in providing the full range of safety activities to support the local business, including safety training, participation in local medical teams providing safety information.

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 /GPS 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

Compliance Activities:

• Works with Safety Country Lead to maintain required standard of local operating performance and reporting compliance for AE case and periodic safety reports
• 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 Country Lead
• 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 Country Lead 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 Country Lead to support the local implementation of risk minimization activities associated with approved risk management plans

Key Knowledge & Skills

• Growing understanding of local safety-related legislation and regulatory requirements
• Computer literacy with basic knowledge of database systems and the ability to utilize AI tools to support PV operations and data management
• Understanding of relevant medical and pharmacovigilance terminology

Education & Experience Requirements

• Minimum 3 years of experience in Pharmacovigilance (PV)
• Proficient in English (reading, writing, speaking)
• Licensed pharmacist preferred