Latest job information from Exelixis for the position of Drug Safety Associate III. If the Drug Safety Associate III vacancy in Alameda matches your qualifications, please submit your latest application or CV directly through the updated Jobkos job portal.
Please note that applying for a job may not always be easy, as new candidates must meet certain qualifications and requirements set by the company. We hope the career opportunity at Exelixis for the position of Drug Safety Associate III below matches your qualifications.
SUMMARY/JOB PURPOSE: This role is responsible for providing Drug Safety expertise and ensuring the quality documentation of safety data, particularly serious adverse events (SAEs). This role provides support for all major tasks and oversight of outsourced vendors, related to the management and best utilization of case processing activities in the Argus Safety Database, ensuring compliance with global clinical safety and pharmacovigilance regulations and Global Patient Safety department procedures in all aspects of drug safety case processing and reporting. This role provides support and oversight of all aspects of drug safety study operational activities from study start up to close out. ESSENTIAL DUTIES AND RESPONSIBILITIES: Technical duties include but are not limited to: * Processing and assessing SAEs from receipt at Exelixis to case closure in the Argus database, including query generation, narrative, and ASE writing. * MedDRA coding of SAEs and AEs as reported in source documents of SAE reports and development/revision of Exelixis MedDRA Coding Conventions to ensure consistent data categorization. * Defining and applying a high standard of case quality review to ensure sound medical safety data documentation with the support of the Drug Safety Physician. * Scheduling submissions of expedited safety reports in ARGUS as needed. * Training of new safety staff on Argus and case processing. * Collaborating with other Exelixis departments (Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, Project Management) to ensure appropriate collection and handling of safety data. * Performing Safety Study Lead activities including: * Review of, Investigator Brochures, study protocols and participation on IND Annual Reports in support of the Drug Safety Physician. * Development of study specific safety management plan from Exelixis Drug Safety template * Development, review and update of drug safety forms and templates, and harmonization with relevant clinical operation forms and templates (i.e., SAE data collection form and CRF) * Perform SAE reconciliation, as required by safety management plan. * Additional duties and responsibilities as required. SUPERVISORY RESPONSIBILITIES: * None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: * BS/BA degree in Nursing, Pharmacy, other clinical, or related discipline and a minimum of 7 years of related experience; or, * MS/MA degree in Nursing, Pharmacy, other clinical, or related discipline and a minimum of 5 years of related experience; or, * PhD in Nursing, Pharmacy, other clinical, or related discipline and 0 or more years of related experience; or, * Equivalent combination of education and experience. * May require certification in assigned area. Experience/The Ideal for Successful Entry into Job: * Experience in Biotech/Pharmaceutical industry and/or in oncology preferred. * Experience using Argus safety database preferred. * Clinical trial and spontaneous adverse event processing experience. Knowledge/Skills: * Knowledge of biotechnology/pharmaceutical sector. * Knowledge of regulatory framework governing patient safety. * Adopts an analytical approach to solve problems relevant to the role. * Demonstrates an understanding of organizational and planning capabilities by managing own time and resources to complete assigned work. * Leads self by managing and executing own work to deliver results that contribute to accomplishing common departmental goals. * Provides verbal and written communications that are clear and easy to understand. Keeps management informed of potential issues in a timely manner. * Works collaboratively with team members. * Good interpersonal skills, understanding of differing views and participation in developing agreed upon resolution. * Trains on procedures, tasks and tools for role, supported by ongoing coaching and/or mentoring by departmental peers. Develops and maintains knowledge of cross-functional products, tools and data sources. May mentor junior team members. JOB COMPLEXITY: * Capable of following predefined procedures for specific tasks. * Capable of identifying task-related challenges and prioritizing activity accordingly. * Identifies and escalates issues that may have a broader impact. * Implements solutions to address any task-related challenges. WORKING CONDITIONS: * Environment: primarily working indoors, performing clerical work #LI-MB1 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 $124,500 - $177,000 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.
Job Info:
Company: Exelixis
Position: Drug Safety Associate III
Work Location: Alameda
Country: US
How to Submit an Application:
After reading and understanding the criteria and minimum qualification requirements explained in the job information Drug Safety Associate III at the office Alameda above, immediately complete the job application files such as a job application letter, CV, photocopy of diploma, transcript, and other supplements as explained above. Submit via the Next Page link below.
THIS JOB POSTING HAS EXPIRED (Over 30 days ago).
Please search for the latest job opportunities on our
Homepage.
Desc: SUMMARY/JOB PURPOSE: The Compliance QA Manager, QA Core, is responsible for coordinating and maintaining inspection readiness activities and provides support for assessing proposed corrective and prev...
Desc: THE COMPANY Saildrone is a maritime defense company and the global leader in autonomous unmanned surface vehicles (USVs). With more ocean miles and real‑world operational experience than any USV manuf...
Desc: A pioneering energy technology firm in Alameda, CA is seeking a Senior Mechanical Engineer to lead mechanical design and deployment for high-temperature fluid systems. Candidates should have over 7 ye...
Desc: A leading manufacturing solutions provider is seeking a Manufacturing Analyst/Manufacturing Engineer in Alameda, CA. The ideal candidate will have over 8 years of experience in manufacturing data anal...
Desc: SUMMARY/JOB PURPOSE (Basic purpose of the job): The Clinical Pharmacology Associate II supports the clinical pharmacology and DMPK functions in pharmacokinetics (PK) data assembly, calculation, analys...