Global Safety Dir - Global Pharmacovigilance Lead

Cambridge, MA, US
Sep 20, 2019
Required Education
Bachelors Degree
Position Type
Full time
Amgen is seeking a Global Pharmacovigilance (PV) Scientist Lead to join our team and work from Amgen's beautiful campus in Cambridge, Ma. To learn more about this position:

The Global Safety Therapeutic Areas serve as the safety experts for all Amgen products globally and are accountable for the safety strategy and major safety deliverables for each Amgen product. Leaders in the therapeutic area safety teams are accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations.

The Global PV Scientist Lead works with the Therapeutic Safety Heads to set direction and strategy for safety assessment activities for the medical/scientific operations with responsibility for providing process insight globally for all products.
This person is accountable for the staff management of the PV Scientists in the therapeutic area and resource planning. Additionally, the incumbent also serves to support the GSO as a safety expert to work on the safety deliverables.
The PV Scientist Lead works closely with the Therapeutic Area Heads (TAH) as well as functional heads to implement new and revised processes and pharmacovigilance standards across GPS. This person will also provide scientific and compliance expertise as needed to GPS.

Provides oversight and is an expert advisor to junior PV Scientists to ensure the following activities are performed according to Amgen SOPs across all therapeutic teams.
Applicable tasks may vary by product(s) assigned. The PV Scientist Lead is responsible for overseeing more junior scientists in the following activities and /or may be responsible for the following tasks them self:
Directs the planning, preparation, writing and review of aggregate reports
Organizes and directs liaison activities with affiliates and other internal Amgen partner regarding products as needed.
Supports and provides oversight to staff with regards to safety in clinical trials including:
ore view of SAEs/AEs as needed
Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents
Review standard design of tables, figures, and listings for safety data from clinical studies
Participate in development of safety-related data collection forms for clinical studies
Participate and contribute to study team meetings as requested or needed
Signal detection, evaluation, and management:
Perform data analysis to evaluate safety observations and write up analysis results
Author of Safety Assessment Reports and other safety documents and regulatory responses
Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
Prepare and deliver presentation of the Global Safety Team's recommendations on safety issues to the cross-functional Executive Safety Committee decision-making body
Assist GSO in the development of risk management strategy and activities including:
Provides contents for risk management plans
Develop or update strategy and content for regional risk management plans
Assist GSOs to oversee risk minimization activities including tracking of activities as needed
Evaluate risk minimization activity
Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO
Activities related to new drug applications and other regulatory filings:
Assist GSO in developing a strategy for safety-related regulatory activities
Provide safety contents for filings

Perform other activities that are delegated by the GSO
Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor
Inspection Readiness
Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
The PV Scientist Lead provides strategy and leadership to the Safety Therapeutic Team:
Contribute to the development, improvement, and standardization of pharmacovigilance processes and methods
Lead the implementation of new processes and methods within and across the Therapeutic Areas

Management Responsibilities
Ensure staff are compliant with Amgen corporate and departmental training and SOP review
Provide training, coaching, mentoring, and development of staff
Assist in the recruitment of talented GPS and AMGEN staff
Assist the leadership team to build an organization and processes that will support future department, company, and industry changes
Responsible for Safety budget and headcount within their area of responsibility
Accountable for disseminating and representing corporate and departmental information to staff and ensuring understanding and adherence to changes
Development plans for staff created annually and reviewed quarterly
Responsible for staff and organizational development including effective talent management, succession planning and performance management and onboarding
Responsible for organizational management through ERP tools, expense report reviews, invoice approvals, timecard review and approval, overtime approval, vacation requests, etc.
Distribute work as appropriate and assign staff to teams

Processes and regulations for pharmacovigilance and risk management
Drug development and lifecycle management
Safety data capture in clinical development and post-market settings
Safety database structure and conventions
MedDRA and other dictionaries used in pharmacovigilance
Methods of qualitative and quantitative safety data analysis
Product and disease state knowledge
General medicine, epidemiology, physiology, and pharmacology
Risk management and risk minimization
Inter-relationship across various pharmacovigilance processes and documents, including reference safety information and product labeling
Advanced understanding of interfaces across various pharmacovigilance and risk management processes
Internal organizational and governance structure
Pharmacovigilance skills-Advanced Skills
Signal detection, evaluation and management
Aggregate data analysis
Sound clinical and scientific judgment
Application of medical concepts and terminology
Advance skills writing Risk Management plans
Data interpretation and synthesis• Ability to convey complex, scientific data in an understandable way
Ability to analyze and interpret complex safety data
Advanced skills in application of statistical and epidemiological methods to pharmacovigilance
Biomedical Literature-Advance skills
Literature Surveillance: Advance source document review knowledge and skills
Literature search, evaluation and assessment skills-ability to search literature databases to identify safety literature for signal evaluation and assessment, interpretation and synthesis skills
Other skills-Advance skills in the following
Advance organization, prioritization, planning skills
Collaboration with cross-functional team settings
Meeting management and time management skills
Process and project management
Critical scientific assessment and problem solving
Written and verbal communications skills, including medical/scientific writing
Computer skills (e.g., MS Office Suite and safety systems)
Strategic thinking
Influencing and negotiation in a cross-functional, matrix environment
Presentation skills for conveying complex technical contents to non-expert audiences
Team leadership and mentoring in a cross-functional, matrix environment

Applies advanced PV subject matter expert within defined subject area
Applies expert knowledge and broad understanding of multiple disciplines
Understands impact of emerging scientific/technical trends and their implications for Amgen

Analyzes and forecasts scientific/technical trends
Develops complex solutions to problems through in-depth analysis, coordination and negotiation with key decision makers
Performs complex work-flow analysis on processes impacting multiple areas across the organization
Adapts and integrates own experience with Amgen-wide strategy
Develops innovative solutions to problems without precedent
Proposes and supports implementation of new processes to achieve strategic business objectives
Works in partnership with management to develop business plans that support the direction of the business

Guided by business plans and strategy:
Executes strategy, goals and changes within area of responsibility
Contributes to strategic decisions affecting the discipline
Directs management of program execution and services
Guides ideas through development into a final product

Contributes to business results through quality of results, advice and decisions related to the operations of the discipline
Designs and develops global processes, systems and/or applications
Contributes to organizational through leadership
May accomplish business results through leveraging a team of professionals and/or managers
Develops mutually beneficial strategic alliances with internal and external contacts
Serves as a role model and mentor

Basic Qualifications:

Doctorate degree and 4 years of directly related experience
Master's degree and 8 years of directly related experience
Bachelor's degree and 10 years of directly related experience
6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

MS in life sciences and 8 years of directly related experience
Bachelor's degree and 10 years of directly related experience
4 years of managerial experience directly managing people and/or leadership experience leading teams, projects programs or directing the allocation of resources.
Clinical/medical research experience
6 plus years of product safety experience in a biotech/pharmaceutical setting
Previous management and/or mentoring experience

Amgen provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow.

Amgen focuses on areas of high unmet medical needs and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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.