Global Safety Manager

**Malaysia - Kuala Lumpur**

**JOB ID**:
R-215028

**LOCATION**:

- Malaysia - Kuala Lumpur

**WORK LOCATION TYPE**:
Flex Commuter / Hybrid

**DATE POSTED**:
May. 13, 2025

**CATEGORY**:
Safety

**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) are the fastest growing region in Amgen. Now we are hiring a Global Safety Manager in Kuala Lumpur, Malaysia**.**

**Live**

**What you will do**

As part of Global Patient Safety, the Global Safety Manager is to be responsible for representing the local safety function on behalf of their country(ies) 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.

**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
- 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 collaborators 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 informatio