Periodic Report Manager

Career Category Safety 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