Global Periodic Reports Senior Scientist Full-time NEW

Global Periodic Reports Senior Scientist

Join Amgen's Mission of Serving Patients

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

In this vital role you will contribute to the design and development for the operating policies and procedures for the maintenance and management of the Amgen Safety periodic reporting processes, schedules, outputs, and metrics throughout the product's life cycle.

• Partners in the development of standards for the PASR process,
• Contributes to the design and development of PASR SOPs, QRGS, and applications for PASRs including the development and submission timeline, interface to SMEs within Global Patient Safety and non safety functions that support the PASRs, and QC of documents for completeness.
• Contributes to design and development of software to track PASR processes including the scheduling of PASRs and data specifications for the safety database outputs that support PASR generation.
• Assess the effectiveness of the PASR process for continuous improvement
• Responsible for fostering relationships with the external PASR vendor and all SMEs involved in the PASR process, the development and submission timeline, interface to Global Patient Safety, and QC of documents for completeness.
• Responsible for effective and accurate development and maintenance of Global regulatory requirements and standards for PASRs and serves as level 2 BPO for SOPs, QRGs and templates related to Periodic Reports.
• Translates PASR country requirements to ensure minimum number of PASRs are prepared to fulfill global needs, negotiating with Local Safety Officers and Regulatory Agencies to enable this.
• Responsible for the robustness of the periodic reporting process, successful alignment and tracking of PASR timelines for the scheduling, QC and key performance metrics and key compliance metrics.
• Responsible for the periodic reports distribution process covering publishing, distribution, submission, and archiving in close collaboration with Business Partners, Contract Research Organizations, Global Regulatory Operations, and outsourced Publishing teams,
• Ensure end-to-end process adherence by all SMEs involved in PASR process
• Responsible for accurate interpretation of regulatory requirements, internal working standards and guidelines to ensure the consistency of PASRs
• Represents the activities of Safety periodic reporting process planning in internal committees and with external parties such as regulatory agencies.
• Contributes to strategy for interactions and responses to health authority rapporteurs and oversight bodies such as PRAC.
• Ensure frequent interaction and collaboration and communication with Global Patient Safety Management e.g. TA Safety Group Heads and non-safety department leadership
• Responsible for ensuring Amgen adheres to and is aligned with Global Health Authority regulations and SOPS regarding all aspects of creating and submitting periodic reports. Monitor changes in regulations to ensure that Amgen remains aligned with evolving requirements of the relevant legislation
• Responsible to ensure cross-linking and consistency across periodic reports and across product teams to ensure standardization e.g. PBRER/PSUR and RMP
• Frequently trains and mentors PASR SMEs with respect to report production
• Lead or contribute to cross-functional initiatives aimed to improve pharmacovigilance capabilities to related periodic reports
• Apply and inform teams of new or revised regulatory requirements and guidelines relevant to periodic reporting
• Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by their supervisor
• 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

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a scientist with these qualifications.

Basic Qualifications:

Degree educated with proven experience of working in pharmaceutical, biotech or regulatory authority experience in a research and development setting

Preferred Qualifications:

• BS, RPH, RN HCP, or Life Science with directly relevant experience (including extensive experience in Drug Safety)
• Demonstrate knowledge of global aspects of pharmacovigilance
• Strong knowledge of processes and global regulations for pharmacovigilance and periodic / aggregate reporting
• Understanding impact of emerging regulatory requirements and their implications for Amgen
• Subject matter expertise and technical excellence
• Experience working on cross-functional teams
• Good knowledge of IT systems and IT standards
• Ability to effectively manage competing priorities and timelines
• Excellence in oral and written English
• Strong leadership skills, independence, networking and influencing skills and managerial experience to deal with potential conflict of partners with the ability to bring a diverse group to a common decision
• Proven leadership skills in execution of goals and processes
• Ensures Amgen remains in compliance and becomes best in class with regard to periodic / aggregate report processes
• Responsible to ensures Amgen is active in regulations, guidelines and industry standards that affect the processes of the periodic report processes.
• Complete and maintains document standards
• Responsible for successful alignment and tracking of metrics, timelines, and performance indicators for PASR objectives

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

Location: Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace. Fully remote would be considered

Apply now and make a lasting impact with the Amgen team.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided 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 accommodation.