Exelixis

This role is responsible for overseeing all aspects of drug safety study operational activities from study start up to close out.. Oversight and review of drug safety operations practices.. Develop and/or update SOPs, processes and practices for SAE and other safety data collection in accordance with drug safety and pharmacovigilance regulations, ICH standards and guidelines as appropriate to ensure timely and compliance submissions to worldwide regulatory agencies. Ensure case reports are appropriately scheduled in Argus based on regulatory reporting matrix in conjunction with Drug Safety submissions.. Oversee Drug Safety Study Team Leads activities including review of study protocols, case report forms, Investigator Brochures and participation on IND Annual Reports in support of the Drug Safety Physician.

drug safety

SUMMARY/JOB PURPOSE:
This role is responsible for overseeing all aspects of drug safety study operational activities from study start up to close out. This individual oversees case workload distribution, responds to case questions, coordinates multiple drug safety projects and/or studies simultaneously, involving interaction with business partners, CRO's, and specialty pharmacies as well as different members of Exelixis' cross-functional departments.
Essential Duties And Responsibilities:
Oversight and review of drug safety operations practices. Activities include, but are not limited to:
Collaborate with other Exelixis stakeholders (including Clinical Development, Clinical Operations, Data Management, Medical Affairs and Regulatory Affairs) to ensure appropriate collection and handling of safety data. Liaise externally with Drug Safety vendor and business partners on case management issues, processes and timelines to meet global regulatory requirements for SAE reporting and other data exchange obligations. Develop and/or update SOPs, processes and practices for SAE and other safety data collection in accordance with drug safety and pharmacovigilance regulations, ICH standards and guidelines as appropriate to ensure timely and compliance submissions to worldwide regulatory agencies Oversee workload distribution in coordination with Drug Safety Workflow Manager. Ensure case reports are appropriately scheduled in Argus based on regulatory reporting matrix in conjunction with Drug Safety submissions. Ensure functional area is appropriately staffed with employees, consultants and/or temporary workers who are developed and trained to do the work necessary for the success of the functional area and team satisfaction. Oversee the generation, validation, and reinforcement of processes and workflows for safety data processing to match Exelixis' current structure and contracting agreements. Oversee Drug Safety Study Team Leads activities including review of study protocols, case report forms, Investigator Brochures and participation on IND Annual Reports in support of the Drug Safety Physician. Assist Drug Safety management with metrics, budget forecasting, and headcount needs. Additional duties and responsibilities as required. Supervisory Responsibilities:
Directly supervises employees. Indirectly supervises employee(s) through a dotted line structure or via other subordinate supervisors. EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
BS/BA degree in related discipline and a minimum of thirteen years of related experience; or, MS/MA degree in related discipline and a minimum of eleven years of related experience; or, PhD in related discipline and a minimum of eight years of related experience, or; Equivalent combination of education and experience. Experience/The Ideal for Successful Entry into Job:
Drug Safety and previous Operations experience required. Experience using Argus safety database preferred. Knowledge/Skills:
Extensive knowledge of biotechnology/pharmaceutical sector drivers and practices. Demonstrated and excellent knowledge of relevant international regulations, guidance and initiatives governing both clinical trial and post-marketing safety environments. Demonstrates advanced skill and keen insight in gathering, sorting and applying key information to solve problems. Demonstrates good organizational and planning skills by managing time, workload and resources of a team. Leads and manages a team to execute on team objectives that contribute to accomplishing common functional and departmental goals. Demonstrates clear and effective verbal and written communication. Provides timely and appropriate information updates. Speaks clearly and confidently in one-to-one situations and effectively presents information to cross-functional groups of team members and colleagues. Fosters collaboration among team members. Encourages teams to align on common goals. Engages internal and external stakeholders to build relationships. Good interpersonal skills and demonstrable ability to bring differing views to develop an agreed upon resolution. Develops procedures, tasks and tools. Trains staff on departmental products, tools and data sources. Develops and maintains knowledge of cross-functional products, tools and data sources. Mentors junior team members. JOB COMPLEXITY:
Capable of proactively assessing workload, trends, tasks and priorities for area of responsibility Plans and executes multiple activities Considers alternative methods and contingency plans to avoid potential issues Designs and implements solutions to address project level challenges, taking into consideration the broader impact Working Conditions:
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If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $210,000 - $297,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER
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. #J-18808-Ljbffr

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