Job Description

Job Title: Global Periodic Reports - Senior CoordinatorJob Location: Hyderabad, Telangana, IndiaJob Location Type: On-siteJob Contract Type: Full-timeJob Seniority Level:Join Amgens Mission of Serving PatientsAt Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionxe2x80x94to serve patients living with serious illnessesxe2x80x94drives all that we do.Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Global Periodic Reports - Senior CoordinatorWhat You Will DoLets do this. Lets change the world. This position plays a role in the design, development, and implementation of operating policies and procedures for maintaining and managing Amgens Periodic Aggregate Safety Reports (PASR) processes and associated metrics throughout the product lifecycle.

• Process Development and Oversight

• Contribute to the creation and continuous improvement of operating policies and procedures for PASR team
• Ensure the maintenance of robust systems and processes to support compliance and quality.
• Metrics and Reporting

• Generate, analyze, and assess PASR metrics, including Key Compliance Indicators (KCIs) and Key Performance Indicators (KPIs).
• Quality Assurance

• Lead quality assurance activities for PASRs to uphold high standards of accuracy and compliance.
• Training and Resource Management

• Maintain and update PASR training materials, and Quick Reference Guides.
• Responsible for overseeing the management and maintenance of assignment vehicles within the Learning Management System (LMS) for PASR team, including external vendors, to ensure compliance with training requirements and operational consistency
• Act as a mentor and centralized resource for training safety and corporate team members involved in Periodic Reporting processes.
• Serve as the central point of contact for Global Patient Safety on matters related to Amgen Regulatory Information Management (RIM).
• Collaborate with and provide support to Global Periodic Report Scientists and other key customers as needed.
• Coordinate and schedule all meetings with cross-functional partners to ensure effective collaboration and alignment
• Lead all aspects of the publishing approval processes for all PASRs, ensuring timely and compliant submissions.
• May assist with Integrated Case Management and Coding activities as required

Key Activities:

• Responsible for the generation and assessment of PASR metrics, including all Key Compliance Indicators and Key Performance Indicators
• Responsible for the Quality Assurance activities for PASRs
• Responsible for the publishing approval of all PASRs
• Responsible for the scheduling of all PASR meetings throughout PASR production
• Responsible for the maintenance of PASR training materials, training Assignment Vehicles and Quick Reference Guides
• Acts as the central point of contact for Global Patient Safety for Amgen RIM
• Provides centralized mentoring, training, for Safety and corporate members who work on Periodic Reports.
• Provides support to Integrated Case Management and Coding team as required.

Inspection Readiness:

• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• Support audit and inspection deliverables, including but not limited to information requests and response QC.

What We Expect Of YouWe are all different, yet we all use our unique contributions to serve patients. The professional we seek should have below qualifications.Basic Qualifications:

• Doctorate degree OR
• Masters degree and 4 to 6 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting OR
• Bachelors degree and 6 to 8 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting OR
• Diploma and 10 to 12 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience
• Strategic approach, attention to detail, and the ability to work collaboratively across multiple teams to ensure compliance, operational efficiency, and continuous improvement within Pharmacovigilance Operations.
• Demonstrate knowledge of global aspects of pharmacovigilance
• Strong knowledge of processes and global regulations for pharmacovigilance and periodic / aggregate reporting
• Good knowledge of IT systems and IT standards including document management systems e.g. Veeva vault
• Ability to effectively handle challenging priorities and timelines
• Excellence in oral and written English
• Strong leadership skills, independence, networking and influencing skills

Contribution:

• Ensures Amgen remains in compliance and becomes best in class with regard to periodic / aggregate report processes
• Implements and maintains document standards
• Responsible for successful alignment and tracking of metrics, timelines, and performance indicators for PASR objectives.

Preferred Qualifications:

• BS, RPH, RN HCP, or Life Science with 5-8 years of directly relevant experience (including 6 years of experience in Drug Safety)

What You Can Expect Of UsAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.Apply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comAs 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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.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.Lifelancer ( ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.For more details and to find similar roles, please check out the below Lifelancer link.

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