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Global Safety Senior Associate

4 months ago

Kuala Lumpur, Kuala Lumpur, Malaysia Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION?

Amgen is one of the world's leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a Global Safety Senior Associate / Manager (7-months contract) in Malaysia.

Live

What you will do

Key Responsibilities

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 their 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 collaborators 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

Win

What we expect of you

Basic Qualifications

  • Doctorate degree OR
  • Master's degree and 3 years of related experience OR
  • Bachelor's degree and 5 years of related experience OR
  • Associate's degree and 10 years of related experience OR
  • High school diploma / GED and 12 years of related experience

Preferred Qualifications

  • 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

Thrive

What you can expect of us

As we work to develop treatments that take care of others so we work to care for our teammates' professional and personal growth and well-being.

  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.