Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial.
As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we’re seeking to add talented, dedicated employees to power our mission.
Cancer is our cause. Make it yours, too.
The Pharmacovigilance and Risk Management (PVRM) Scientist will support and collaborate with other members of PVRM organization to execute on critical pharmacovigilance activities for Exelixis investigational and marketed products. This role will support safety governance activities, signal detection/management, risk management activities, and contribute to the overall benefit-risk management of assigned products.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Perform and contribute to safety analyses through review of case series, tabulated data and/or AE trend information for assigned product(s)
- Contribute to document authoring, describing the evaluated safety data and for assigned product(s)
- Perform and contribute with more senior scientists and safety physicians to signal detection activities for assigned product(s)and the signal management process
- Collaborate with more senior scientists and safety physicians on risk management activities for assigned product(s)
- Participate in the development and maintenance of Risk Management Plans (RMPs)/Risk Evaluation and Mitigation Strategies (REMS) for assigned product(s)
- Participate in the review of medical/scientific literature to identify literature relevant for signal detection activities and aggregate reporting for assigned product(s)
- Participate in the preparation of aggregate safety reports for assigned product(s)
- Contribute to the creation and maintenance of the Reference Safety Information (RSI) and company core labeling for assigned product(s)
- Contribute, participate and support Benefit-Risk Team meetings for assigned product(s), including materials preparation, meeting minutes, and action item tracking
- Contribute to health authority or other safety related query responses for assigned product(s)
- Participate in inspection /audit related readiness activities and provide support for internal and external PV audits
- Participate in continuous process improvement projects
- BS/BA degree in related discipline and eight years of related experience; or
- MS/MA degree in related discipline and six years of related experience; or
- PhD, MD, or PharmD in related discipline and three to five years of related experience, or
- Equivalent combination of education and experience.
- Experience in Drug Safety and Pharmacovigilance preferred
- Training or equivalent experience in epidemiology or public health beneficial but not required
- Teamwork/collaboration/strong interpersonal skills
- Familiarity with industry principles of drug safety, drug development, pharmacology, biostatistics, and pharmacoepidemiology is preferred.
- Problem solving skills
- Project management
- Excellent written, oral communication and presentation skills
- Ability to follow established processes and the flexibility to adopt new practices, as required
- Good working knowledge of Microsoft office
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.