Pharmacovigilance Operations Senior Mgr

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 Pharmacovigilance Operations Senior Mgr What you will do This role supports the end-to-end writing and documentation process and ensures timelines are met Provide audit external inspection support as required Key Responsibilities Periodic Report Process Supervision of a team of Periodic Report Managers in Amgen India with Periodic Report responsibilities Organise the end-to-end process of report production and ensure the required quality standards and key timelines are met Provide oversight to co-authors as applicable and be accountable for the quality of their work Act as main point of contact for Director of PASR on all Periodic Aggregate Safety Report work Act as a writing coach provide regular quality feedback and share standard processes with team for promoting the use of clear and concise writing and alignment to style guides and templates as applicable Support project management activities including estimation of resource requirement Implement and promote use of consistent efficient and quality processes to meet timelines and work according to requirements and SOPs and assume accountability for the work Ensure compliance of operations with governing regulatory requirements Analysis and communication of PASR quality with Director of PASR team Customer concern of issues around quality and KPIs to Director of PASR Provide metrics for audit inspection support for PASR related activities Literature Management Process Supervision of a team of Literature review scientists Responsible for the business process of and oversight of the global literature review process Responsible for engagement and oversight of system vendors supporting the global literature review process Responsible for training and onboarding of literature review team Responsible for the proposal generation and maintenance of metrics and or KPI KCIs related to global literature review Stay ahead of technology and innovation to improve the efficiency and quality of scientific literature search and review Collaborate with TA Safety and Case Management on process and system improvement opportunities What we expect of you We are all different yet we all use our unique contributions to serve patients The professional we seek is someone with these qualifications Basic Qualifications Doctorate degree Master s degree Bachelor s degree and 12 to 17 years of relevant experience Preferred Qualifications Handling direct reports on a day-to-day basis and raising topics as needed to Director of PASR team Work within the Quality Management System framework including all applicable training and controlled documentation governing Pharmacovigilance processes Responsible for the growth and development of direct reports Ensure monthly review of performance metrics for the PASR process Build and maintain good functional and multi-functional relationships globally 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 work including but not limited to information requests and response QC Extensive knowledge of global regulatory requirements for Pharmacovigilance Extensive knowledge of global PASR requirements Extensive knowledge of authoring PASRs Extensive people management 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 mentality attention to detail and the ability to work multi-functionally 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 handle challenging 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 What you can expect of us As we work to develop treatments that look after 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