Amgen Exec Dir Pharmacovigilance Operations in South San Francisco, California
The Head of Pharmacovigilance Operations is accountable for day-to-day efficient and compliant global pharmacovigilance operational management and oversight groups responsible for case management activities performed internally and externally by vendors (CROs), expedited safety reporting and business partner data exchange, Medical Coding, Commercial and Study Liaison. The successful candidate will be responsible for ensuring all ICSR processing is in compliance with regulatory requirements and corporate and departmental procedures. This role ensures that Amgen has experienced staff (including external vendors) appropriately designated with responsibility to oversee the accurate and timely processing and reporting of drug safety information. This position requires ability to influence without directly managing and partnership with internal and external colleagues in matrix teams and with senior management. This position reports directly to the Vice President of Global Patient Safety and Labeling or delegate.
The Executive Director is responsible for the following:
Leads Amgen's Pharmacovigilance (PV) Operations function including all associated strategic, organizational, quality, training, and compliance activities across multiple sites and diverse cultures;
Provides expert guidance and leadership both internally and externally based on in-depth knowledge of development and post-marketing safety requirements, per ICH; US and international regulations and guidelines; and Good Pharmacovigilance Practice (GPvP).
Drives overall prioritization of PV Operations objectives and initiatives and resolve conflicting priorities;
Proactively identifies business drivers and changes, and incorporates into processes and plans such as global regulatory changes, new product launches, and new partner arrangements;
Accountable for identification, development and implementation of PV process improvements, tools, systems and procedures to enable excellence and consistency in PV operations.
Champions proposals for new technology and innovation for the PV operations team
Ensures individual adverse case reports from all sources are collected, managed and reported according to Amgen's global Standard Operating Procedures (SOPs) and global adverse event regulations and guidelines
Oversees the Commercial and Study Liaison team responsible for ensuring safety data collection requirements are met for Amgen commercial programs such as Patient Support Programs (PSPs) and Market Research (MR) programs, as well as across our study programs be they interventional or observational studies.
Oversee medical coding function responsible for AE and medication coding for all Amgen clinical trials
Provides guidance on the creation, oversight and management of global business partner safety data exchange agreements/ pharmacovigilance agreements and other contracts as applicable to ensure compliance with data exchange activities.
Communicates through all levels of the organization on all safety and compliance program topics including identification, initiation, development and implementation of PV process improvements, tools, systems and procedures to enable excellence and consistency in operations in collaboration
Participate in regulatory inspections and audits to ensure the quality, integrity and compliance with pharmacovigilance and safety reporting requirements, including authoring of responses to findings relevant to functional area
Ensures compliance-related investigations, and development and implementation of corrective actions for deviations from case processing procedures are performed accurately and on time
Oversee the provision of critical infrastructure including: Fiscal control, Analysis of compliance and metrics, quality assurance, training and knowledge management, identify improvement opportunities, lead strategic initiatives and provides resources to manage implementation.
Doctorate degree and 10 years of global Pharmacovigilance experience OR
Master's degree and 12 years of global Pharmacovigilance experience OR
Bachelor's degree and 15 years of global Pharmacovigilance experience AND
6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Advanced medical degree, Doctorate degree, PharmD or MD
10 years or more years of experience in global Pharmacovigilance for a biotechnology or pharmaceutical company in the clinical trial and post marketing environments.
6 years or more years of functional management experience overseeing PV staff
Thorough understanding of the global PV regulatory environment with working knowledge of EU and US regulations, ICH guidelines, and GCP, a working understanding of drug safety databases, effective project management skills, a demonstrated ability to provide critical and timely insight, and analytical problem-solving skills with a broad perspective
Knowledge and Skills:
Ability to lead, plan and manage change
Ability to set priorities and lead safety operational initiatives including staffing
Ability to make sound decisions relating to the advancement of the company mission and goals
Extensive knowledge of Pharmacovigilance processes and local and global regulatory rules and regulations;
Excellent analytical, problem solving, communication and interpersonal skills
Previous experience managing and developing staff.
Ability to lead and participate in teams in a cross-functional team environment.
Expert understanding of safety database; can use full range of database capability and has basic understanding of database structure
Understanding regarding principles of Serious Adverse Event (SAE)/Adverse Event (AE) and Device Vigilance reporting;
Deep understanding of pharmacovigilance processes and requirements; ability to define, establish, and manage global PV processes
Working knowledge of drug development processes and activities
Working knowledge of medical concepts, terms, conditions, and associated pathology
Ability to work in an environment of rapidly changing priorities and workload; ability to manage multi-departmental functions and oversee operations.
Strong initiative, strong organizational and time management skills
Comprehensive knowledge of GCP/ICH guidelines
Well-developed analytical thinking combined with high sense of responsibility and accountability
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, or disability status.
Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.