Career Category

Job Description

Job Summary: 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, GPS 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, GPS 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.

Key Activities:

Key Activities

Broader Management and Co-ordination Activities:

• Provides leadership to local safety team, setting goals and operational guidance in line with 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 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 GPS SOPs and manuals
• Ensures that local safety procedures are documented in line with Amgen

/GPS 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.
• 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

Compliance Management:

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.

-(For European Union- Assists QP PV in designation of local Amgen studies as PASS studies)

-Having system oversight and overview of the safety profiles and emerging safety concerns related to Amgen medicinal products marketed in Saudi Arabia.

• Acting as a single point of contact for the Saudi FDA (National Pharmacovigilance Center) on a 24-hour a day, 7-day a week, basis.
• Monitoring compliance with timelines for expedited safety reporting to local Health Authorities (HAs) and timelines for periodic safety report submission to the local Health Authority (HA).

Knowledge and Skills:

Excellent working knowledge of Amgen's policies, procedures and systems 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.

Education & Experience (Basic):

Doctorate degree OR

Master’s degree and 3 years of directly related experience OR

Bachelor’s degree and 5 years of directly related experience OR

Associate’s degree and 10 years of directly related experience OR

High school diploma / GED and 12 years of directly related experience.

Education & Experience (Preferred):

* Professional qualification as a health care professional (doctor, pharmacist)

* Experience in biotech/pharma industry, clinically based or regulatory agency role.