The purpose of this role is to act as the recognized safety responsible person in the relevant country/countries, managing safety related activities within the local affiliate in line with GRAAS policies and procedures, local regulations and practices, and to link with functions in the local affiliate to meet business needs.
As part of Global Patient Safety, to be responsible for representing the local safety function on behalf of their country(ries) in interactions with Regulatory agencies, GRAAS management, other functions locally and external health care professionals, to achieve Safety objectives. To manage the affiliate Safety team to ensure compliant and efficient performance of safety activities locally, based on sound knowledge of local legislative requirements and practice, GRAAS policies and procedures, with an understanding of the business needs of the local affiliate. To participate in exchange of safety information throughout the Amgen Global organisation to support informed understanding of product safety issues.
Broader Management and Co-ordination Activities:
- Provides leadership to local safety team, setting goals and operational guidance in line with GRAAS & GPS objectives
- Manages local staff and budget resources
- Works with Regional safety leads on process improvement initiatives or implementation of legislative changes
- Guides training and development activities for local safety staff
- Participates in global/ regional /country safety meetings to share best practice
- Provides input into cross functional programs, to reflect local requirements
- Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor
Strategic Planning Activities:
- Provides affiliate input to GRAAS /GPS senior management planning of regional safety organisation development, capacity management, resourcing and talent management initiatives
Activities as Local Safety Responsible Person (For local country or countries):
- Is nominated to country regulatory authority as local safety responsible person
- Acts as safety subject matter expert within the affiliate
- Maintains own current knowledge of and compliance with local safety regulations for country or countries under responsibility
- Communicates requirements and updates to Safety BPOs and line manager, and ensures local affiliates safety requirements are up to date in GRAAS SOPs and manuals
- Ensures that local safety procedures are documented in line with Amgen /GRAAS policies and procedures
- Collaborates locally with all relevant stakeholders to ensure 24 hour contact ability of the safety function for urgent issues is available
- Works with local teams to establish, review and revise Pharmacovigilance and/or contract agreements with partners, contractors/vendors and distributors, as applicable
- Ensures that training on adverse reporting obligations is available for local customer-facing staff and others required by national practice or Company policy, also for relevant contractors, agents or business partners or distributors
- Participates in local Crisis Management teams; provides ongoing safety advice
- 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
Management of Core Safety Affiliate Responsibilities:
Manages affiliate staff, and confirms completion of their training, to ensure:
- Timely & accurate capture, routing, , translation, and follow up of all adverse events reported to the local country(ies), , for inclusion in the Global Safety Database
- Arranges safety review of local medical literature
- Oversees submission of all reportable adverse drug reaction reports & the distribution of periodic safety reports, as required by local regulations and Amgen procedures.
- Assists intake of product complaints in countries where local safety department is designated to support product quality department with this activity.
- Collaborates in the planning and dissemination of urgent safety communications, DHPCs & DILs required by Amgen decisions or Regulatory Agency demands, according to local requirements.
- Assists in tailoring of core risk management plans or periodic reports to local regulatory requirements, for specific countries not covered by regional versions.
- Supports the local implementation of risk minimization activities associated with approved risk management plans
- Facilitates exchange of adverse event information with functional service providers or business partners, or distributors, in line with specific agreements or procedures
- Supports intake of product complaints if assigned in absence of local QA specialist
Reviews metrics generated from Global Safety database to monitor local operating performance and reporting compliance within the affiliate Safety function, for AE case and periodic safety reports.
- Takes responsibility for seeking resolution of local issues that occur, through CAPAs and related activities.
- Ensures local quality assurance measures to support data quality and maintain inspection readiness of local safety function.
-Provides local Safety expertise to local stakeholders for review of plans / vendor contracts of local market research studies and patient support programmes to ensure safety contract language, training, monitoring and data collection are appropriately addressed.
- May provide local safety expertise for review of protocols of local interventional, non-interventional studies (NIS) and independently sponsored studies to ensure safety monitoring and data collection are appropriately addressed, liaising with Medical or SOPS teams as relevant.
Knowledge and Skills
Deep understanding of legislation which applies to safety practices locally
Computer literacy with thorough knowledge of database use
Thorough knowledge of local data privacy requirements
Understanding of relevant medical & safety terminology
Excellent organizational skills
Understanding of team dynamics
At least 5 years of experiencia in a similar role in big pharma industry
Fluent in English
Professional qualification as a health care professional (doctor, pharmacist , nurse, vet, etc. )
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