Global Pharmacovigilance (PV) Scientist
Few careers offer the chance to create a difference in peoples lives. Take advantage of the opportunity at Amgen, the worlds largest biotechnology company. With global manufacturing operations and clinical development sites on three continents, Amgen is focused and committed to making our products available to improve patients lives through innovative science.
Amgen is seeking a Global Pharmacovigilance (PV) Scientist to join our team.
The Global PV Scientist will join a team of Global PV Scientists working in collaboration with Global Safety Officers (GSO) to provide the safety strategy and major safety deliverables for Amgen product. The Immuno-oncology team has an exciting portfolio of products ranging from Early Development through the Post marketing settings. We need collaborative and innovative world-class talent to ensure these molecules and medicines reach their full potential while helping patients.
The Global PV Scientist is response for the following:
- Conduct signal detection, evaluation, and management
- Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection.
- Perform data analysis to evaluate safety signals and write up analysis results in collaboration with the GSO.
- Prepare presentation of the Global Safety Teams recommendations on safety issues to the cross-functional decision-making bodies.
- Prepare safety assessment reports and other safety documents and regulatory responses.
- Participates in Safety Governance per Amgen processes.
- Contributes to the planning, preparation, writing and review of periodic aggregate safety reports.
- Works with affiliates and other internal Amgen partners regarding deliverables.
- Review of adverse events and serious adverse events from clinical trials.
- 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.
- Attend study team meetings as requested.
- Assist GSOs and other Senior PV Scientists in the development of risk management strategy and activities.
- Provides contents for risk management plans.
- Update strategy and content for regional risk management plans.
- Assist GSOs to oversee risk minimization activities including tracking of activities.
- Evaluate risk minimization activities.
- Support activities related to new drug applications and other regulatory filings.
- Assist GSOs and other Senior PV Scientists in developing a strategy for safety-related regulatory activities.
- Provide safety contents for filings.
- Performs other duties related to the position as defined in Standard Operating Procedures or as requested by his/her supervisor.
- Undertake activities delegated by the Qualified Person For PV (QPPV) as detailed in the PV System Master File and maintains a state of inspection readiness.
- Be the representative and point of contact for Health Authority Inspections and Internal Process Audits within the remit of role and responsibility.
- Contribute to the development, improvement, and standardization of PV processes and methods.
- Participates on teams for the implementation of new processes and methods within the Therapeutic Area.
- Doctorate degree OR
- Masters degree and 3 years of R&D or Scientific or Clinical and/or biotech/pharmaceutical experience OR
- Bachelors degree and 5 years of R&D or Scientific or Clinical and/or biotech/pharmaceutical experience OR
- Associates degree and 10 years of R&D or Scientific or Clinical and/or biotech/pharmaceutical experience OR
- High school diploma / GED and 12 years of R&D or Scientific or Clinical and/or biotech/pharmaceutical experience
- Health care professional background
- 1 year of drug safety/PV experience
- Experience in signal detection, evaluation and management
- Experience as a contributor to periodic aggregate safety reports
- Experience with literature surveillance: source document review, knowledge, and skills
- Experience with the Argus Safety database
- Good clinical and scientific judgment
- Clinical and/or medical research experience
- Strong written and verbal communication skills
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and demonstrates its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen provides a collaborative and creative culture in a company with a consistent 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.Join Us
If you're seeking a career where you can truly make a difference in the lives of others, as well as work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen!
Amgen provides a comprehensive Total Rewards Program designed to enhance the long term financial, physical, and overall well-being of our staff and their families. We offer competitive compensation, long term incentive opportunities, generous paid time off, 401k, medical, dental and vision just to name a few.
As an organization dedicated to improving the quality of life for people around the world, Amgen champions 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.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Join UsIf 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.