Periodic Report Manager

Career Category

Job Description

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.

Periodic Report Manager

What you will do

Let’s do this. Let’s change the world. This position plays a role in the authoring, compilation and peer review of Amgen’s Periodic Aggregate Safety Reports (PASR) e.g. Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR), Semi Annual Safety Update Report (SSUR), Periodic Adverse Drug Experience Report (PADER/PAER), Device PSUR, and country specific reports e.g. Korea PSUR, Brazil PSUR and Colombia Clinical Research Annual Safety Report Submission and Evaluation form. Incompliance with global regulatory requirements. This role supports the end-to-end writing and documentation process and ensures timelines are met.

In addition, this role has oversite of a team of Periodic Report Specialists.

Key Responsibilities:

• Management responsibility for a team of Periodic Report Specialists

• Supervision of a team of Periodic Report Specialists in Amgen India with Periodic Report responsibilities

• Act as primary point of contact for the reports, present anticipated challenges and propose remediation and advance unresolved issues impacting deliverables.

• Act as a writing coach, provide regular quality feedback, and share standard methodologies with PRS for promoting the use of clear and concise writing and adherence to style guides and templates as applicable.

• Ensure compliance of operations with governing regulatory requirements.

Compilation and authoring of PASRs

• Coordinate and schedule all meetings with cross-functional collaborators to ensure effective collaboration and alignment

• Drive report timelines and advance risks or delays to team leads or management

• Collaborate with cross-functional collaborators and external business partners to collect PASR contributions and compile into PASR template.

• Author safety content for all PASRs in collaboration with Therapeutic Area Safety scientists

• Conduct peer QC of safety authored sections, coordinate Amgen review and resolve comments and initiate approval workflows.

• Maintain and archive accurate records and documentation throughout the report process

• Review and approve published report versions (i.e. blinded, unblinded, EU FDA, Rest of World).

• Manage report distribution to Contract Research Organizations (CROs) and Business Partners (BPs)

• Ensure adherence to established timelines, regulatory guidelines and applicable standards, styles, guidelines and processes

• Peer review/quality review of all PASRs within established timelines with adherence to applicable guidelines and processes, using appropriate checklists

• Maintain and develop current knowledge of regulatory guidelines, technological advances and industry standards

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

• Management of a team of Periodic Report Specialists

• Responsible for the generation, including authoring of safety sections of all PASRs, including publishing approvals, metrics generation and archiving of source documents.

• Responsible for the scheduling and lead of all PASR meetings throughout PASR production

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 you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• Master’s degree and 4 to 6 years of pharmaceutical, biotech or regulatory authority experince in a research and development setting experience OR

• Bachelor’s degree and 6 to 8 years ofpharmaceutical, biotech or regulatory authority experience in a research and development setting experience OR

• Diploma and 10 to 12 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience

• Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment

• Understands and interprets data/information and its practical application

• Knowledge of scientific/technical writing and editing

• Excellent English written/oral communication, and strong time and project management skills

• 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

• Ability to effectively manage competing priorities and timelines

• Strong leadership skills, independence, networking and influencing skills

• Computer literate: knowledge of MS work, PowerPoint, Adobe Acrobat, MS Excel, SharePoint and Document Management Systems e.g. Veeva Vault

• Experience in use of AI and prompts would be useful

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 tracking of metrics, timelines, and performance indicators for PASR objectives.

Preferred Qualifications:

• Health Care Professional with minimum 5 - 7 years of relevant work experience including 5 years of experience in periodic aggregate safety report writing

OR

• Bachelor’s / Master’s degree in Health/Life Sciences with minimum 4 years of Experience in managing personnel directly or providing leadership by guiding teams, overseeing projects or programs, or directing resource allocation.

• Overall 5 + years of authoring/editing experience in medical writing domain across different therapeutic areas in safety documents including Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR).

• Experience in preparation of safety documents necessary for national and international regulatory submissions to the US, European Union and other regulatory agencies.

• Knowledge of Pharmacovigilance regulations for Periodic Aggregate Safety Reports.

What you can expect of us

As 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, we’ll 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 now and make a lasting impact with the Amgen team.

careers.amgen.com

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 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.