Career Category

Job Description

Organization

Global Patient Safety

Function

International Safety

Functional Role

Local Safety Officer (Senior Associate)

Job Title / HR Title

(NOTE: Linked to Compensation & Grade Level)

Global Safety Senior Associate

Group Purpose

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.

Job Summary

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 Country Lead 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.

Key Activities

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

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
• Works with Safety Country Lead to keep local affiliate safety requirements up to date in GPS SOPs and manuals, and reporting requirements
• 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, also for relevant contractors, agents, business partners or distributors
• Assists local Safety team during conduct of audits & inspections of safety operations and other PV interactions with local Regulators
• Assists Safety Country Lead and local teams to establish, review and revise Pharmacovigilance and/or contract agreements with partners, contractors/vendors, as applicable

Core Safety Affiliate Operational Responsibilities:

• Timely & accurate capture, routing, translation and follow up of adverse events reported in the local country(ies) for inclusion in the Global Safety database
• Assists with the dissemination of urgent safety communications, DHPCs 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

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
• May assist Safety Country Lead and local teams to establish, review and revise Pharmacovigilance and/or contract agreements with partners, contractors/vendors, and distributors, as applicable
• May assist in safety review of protocols of local interventional, non-interventional studies (NIS) and independently sponsored studies to ensure safety monitoring and data collection are appropriately addressed
• May assist in local safety review of plans / vendor contracts of local market research studies and patient support programs to ensure safety contract language, training, monitoring, and data collection are appropriately addressed
• May assist in review of local Amgen sponsored websites/social media projects, if used, to ensure appropriate compliance measures are implemented, for capture of potential adverse events received
• May assist in tracking dissemination of DHCP and risk minimization measures, such as physician education booklets
• 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

Therapeutic Area Safety Support:

• Escalates product safety issues to Safety Country Lead
• Develops expertise in one or more product or product classes
• Maintains awareness of current prescribing information (eg. SmPC), investigator brochures 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 Information, for topics delegated by Safety Country Lead
  • Assists in providing product safety training to commercial or medical colleagues and if applicable, to business partners, contract providers and distributors
  • Assists Safety Country Lead in local implementation of risk minimization activities associated with approved risk management plans
  • Assists Safety Country Lead to build awareness of product safety issues within local market or clinical research environment and provide feedback to stakeholders as requested by Safety Country Lead.

Additional local responsibilities:

• Deputises for Safety Country Lead when absent, to sustain core activities of local safety team
• May deputise for the Safety Country Lead, nominated to country regulatory authority, as local safety responsible person
• Supervises defined technical or professional activities in maintenance of local Safety function as delegated by Safety Country Lead
• Takes some activities as safety subject matter expert within the affiliate

Knowledge and Skills

• Good working knowledge of Amgen's policies, procedures, and systems
• 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 & Experience (Basic)

Master’s degree
OR
Bachelor’s degree and 2 years of directly related experience
OR
Associate’s degree and 6 years of directly related experience
OR
High school diploma / GED and 8 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