Career Category

Job Description

Job Summary

Supports application of global safety policies to ensure operational effectiveness and compliance by local safety staff and Distributors/local Service Providers performing safety duties on behalf of Amgen, through appropriate goal setting, training oversight, review of KPIs and issue resolution/ escalation. Ensures the group is appropriately resourced to achieve their goals. Remotely lead and manage a culturally diverse team and ensure that local goals are achieved in line with International/global GRAAS plans and strategy.

Overall accountable for:

- Effective and compliant local pharmacovigilance (PV) operations
- Development, implementation and lifecycle management of affiliate offices including support of global expansion.
- Development, implementation and ongoing optimization of regional / local safety infrastructure and staff development.
- Issue elevation for critical items arising from the region.
- Provision of Therapeutic Area Safety interface to regional hubs and local offices for PV requirements and commitments

Responsible for:
- Execution of functional plans and initiatives - as guided by / aligned with GRAAS globally and overall Amgen business strategy
- Participation in key management bodies within the region
- Alignment of International Safety with global GPS strategies
- Leading a team responsible for local safety within the assigned Region
- Developing and implementing International Safety operational strategy within the context of GRAAS/GPS and Amgen's overall, long-term business strategy
- Oversight of assigned distributor/partnership/vendor relationships and performance for PV.

Strategic and Execution
• Provides leadership for regional safety organization, working through local safety leads
• Meet regularly with affiliate staff in region to resolve operational, process, staffing, or challenges within the local affiliates
• Sets annual goals across region aligned with GPS/Int’l safety objectives. Accountable for delivery of goals in assigned region
• Provide safety-related insight and strategy for any assigned regions, including local regulatory, operating and other considerations.
• Provide key input to Head International Safety and Sr. Management for region, communicate management decisions and strategy to regional staff, and provide regional expertise and input as part of the International Safety SLT.
• Clarifies operational objectives for the region, in line with GRAAS policies; monitors metrics for achievement of operational targets to ensure regulatory safety requirements/company policies are maintained
• Maintains awareness of current prescribing information (eg SmPC) and risk management plans to support risk management
• Participates in planning and roll out of proposed risk minimisation activities and consults with affiliates to address local factors
• Maintains communications to facilitate best practice in safety-related areas across the region
• 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

Management
Ensures that the local Safety senior staff are equipped and trained to:
• Act as the local safety expert and contact within the local office
• Ensure proactive PV and safety management for all local safety leads
Ensure regional adherence to all Business and R&D Compliance standards (internal and external)
• Input to development and application of safety and PV systems to support local safety roles and safety compliance.
• Ensures appropriate safety staffing to maintain viable safety function in each office including overall budget and resource planning
• Ensures that all safety obligations are met within the scope of responsibilities and work cross-functionally to resolve any issues
• Oversight for completion of mandatory training across region and maintains oversight of training on and application of Amgen policies to ensure compliance
• Maintains awareness of current product safety areas and issues
• Works with local staff to ensure safety inspection readiness and support of internal and external audits
• Collaborates with sub-regional and country leads, BPOs, and R&D Compliance on CAPAs to restore/maintain compliance and operational effectiveness the region
• Assesses training needs within the regions and partners with Training and Development function to deliver training materials and to support optimal use of safety systems/processes by LSOs
• Collaborates with TA Safety to assign suitably qualified local safety staff to specific product related projects when required.
• Recruit and retain safety professionals and assist in the recruitment of talented GPS /AMGEN staff. Provide coaching, mentoring, and development of staff plus talent management. Supports MAP process
• Work cross-functionally to ensure all aspects of affiliate/regional role responsibilities are prioritized effectively and resources aligned to achieve objectives. Contribute to budget and headcount planning

Collaboration
• Contributes to consultation, planning and implementation or modification of global/regional safety systems/tools/processes
• Supports involvement of local safety staff in processes to ensure timely communication of product safety issues to internal staff and external health care professionals and institutions as needed
• Participates or leads cross-functional initiatives as safety representative particularly for activities affecting affiliates

External
• Participates in planning, oversight, and maintenance of FSP services as appropriate
• Maintains awareness of significant safety legislative changes within region to contribute to impact assessment and potential change management activities
• Facilitates consultations with LAOs on local legislation, requirements and practices to provide input to maintain and update standard reference documents
• Represent Amgen Global Safety with external partners for effective partner relations and operations in adherence to established safety agreements
• Accountable and responsible for all safety activities related to distributor operations regionally. May also include global distributor safety oversight (negotiations of agreements, process development and implementation, lifecycle management, training programs, compliance monitoring and follow-up)
• Performs PV Due Diligence and integration activities for Mergers and Acquisitions

HA Interaction
• In co-ordination with Amgen senior Regulatory staff, interacts and negotiates with key regulatory agency officials for PV. Advocate for Amgen/GPS by building strong relationships with key external stakeholders including influential professional bodies

Basic Qualifications

Doctorate degree and 4 years of directly related experience
OR
Master’s degree and 8 years of directly related experience
OR
Bachelor’s degree and 10 years of directly related experience
AND
6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications

1. Deep knowledge of PV principles including region specific knowledge
2. Expert knowledge of regional safety regulatory environment
3. Awareness of broad range of Amgen policies and procedures
4. Excellent working knowledge of the people and processes involved in safety data handling and submission
5. Strong and effective communication skills - both oral and written
6. Organizational savvy: strong diplomacy and negotiation skills
7. Ability to anticipate and mitigate against future strategic issues and uncertainties
8. Demonstrated ability to set organizational direction and champion change and continuous improvement
9. Experience of general operating environment for Biotechnology/pharmaceutical industries
10. Experience of staff management on local and international basis

Competencies
• Command skills
• Conflict management
• Directing others
• Managing diversity
• Listening
• Managing and measuring work
• Building effective teams
• Issue and crisis management

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.