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Field Medical Director
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Medical Director, Patient Safety
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Arcus Biosciences Hayward, United StatesThe Medical Director, Patient Safety and Pharmacovigilance will provide medical expertise across the growing Arcus clinical portfolio by supporting a variety of core medical safety activities including the management of safety signal, risk management, benefit-risk strategies, and ...
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Director, Medical Staff
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Oncology Medical Director
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Director Medical Equipment
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Medical Director of Psychosomatics
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Veterinary Medical Director
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Sr. Medical Affairs Medical Director
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Exelixis, Inc. Alameda, CA, United StatesSr. Medical Affairs Medical Director page is loaded · Sr. Medical Affairs Medical Director · Apply locations Alameda, CA King of Prussia, PA time type Full time posted on Posted 3 Days Ago job requisition id JR5534 SUMMARY/JOB PURPOSE: · Support the early-stage pipeline by wo ...
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Sr. Medical Affairs Medical Director
1 week ago
Exelixis Alameda, CA, United StatesSUMMARY/JOB PURPOSE: · Support the early-stage pipeline by working across the Medical Affairs sub-functions, including the Medical Communications, Medical Information, Medical Science Liaison, and Operations teams. This position also work with several cross functional stakeholde ...
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Sr. Medical Affairs Medical Director
1 week ago
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Medical Director, Experience of Care
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Director, Medical Writing Consultant
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EVERSANA San Francisco, United States**Company Description** · At EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We're fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commerc ...
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Medical Clinic Director- MD or DO
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Exelixis, Inc. Alameda, CA, United StatesPharmacovigilance Risk Management Medical Director (PVRM) page is loaded Pharmacovigilance Risk Management Medical Director (PVRM) · Apply locations Alameda, CA King of Prussia, PA time type Full time posted on Posted 3 Days Ago job requisition id JR5530 SUMMARY/JOB PURPOSE: · T ...
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Exelixis, Inc. Alameda, CA, United StatesPharmacovigilance Risk Management Medical Director (PVRM) page is loaded · Pharmacovigilance Risk Management Medical Director (PVRM) · Apply locations Alameda, CA King of Prussia, PA time type Full time posted on Posted 3 Days Ago job requisition id JR5530 SUMMARY/JOB PURPOSE: ...
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Exelixis Inc. Alameda, CA, United StatesSUMMARY/JOB PURPOSE: · The PVRM Medical Director is responsible for the medical review of Individual Case Safety Reports (ICSRs) for Exelixis products and is involved with other safety deliverables (eg safety surveillance) for assigned project(s). The role collaborates closely w ...
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Exelixis Alameda, CA, United StatesSUMMARY/JOB PURPOSE: · The PVRM Medical Director is responsible for the medical review of Individual Case Safety Reports (ICSRs) for Exelixis products and is involved with other safety deliverables (eg safety surveillance) for assigned project(s). The role collaborates closely w ...
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Exelixis Alameda, United States Full timeSUMMARY/JOB PURPOSE: · The PVRM Medical Director is responsible for the medical review of Individual Case Safety Reports (ICSRs) for Exelixis products and is involved with other safety deliverables (eg safety surveillance) for assigned project(s). The role collaborates closely w ...
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Gilead Sciences Foster City, United StatesFor Current Gilead Employees and Contractors: · Please log onto your · Internal Career Site · At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to dev ...
Pharmacovigilance Risk Management Medical Director - Alameda, CA, United States - Exelixis
Description
The PVRM Medical Director is responsible for the medical review of Individual Case Safety Reports (ICSRs) for Exelixis products and is involved with other safety deliverables (eg safety surveillance) for assigned project(s).
The role collaborates closely with Drug Safety Operations staff (on medical aspects of ICSRs) and Clinical Development (medical ICSR discussion and follow-up, as well as safety surveillance).
The role supports regulatory compliance with pharmacovigilance regulations, safety signal detection/management, and contributes to the overall benefit-risk management of Exelixis products.
This role operates in a matrix environment within the drug safety function and cross-functionally with other departments. Perform medical review of ICSRs for assigned product(s) in clinical development or for marketed productsEnsure that ICSRs contain accurate medical content through appropriate querying and obtained source data verification.
Collaborate closely with Drug Safety staff providing medical expertise and guidance for proper gathering, evaluation, medical assessment, and follow-up of ICSRs.
Review and/or Author an Analysis of Similar Events (ASE) for expedited cases.Identify clinically important cases and lead the discussion on such cases by liaising with the medical monitor of the respective clinical study to discuss next steps.
Contribute to aggregate safety data reviews, signal evaluation, interpretation and documentation for assigned project(s) or product(s)Provide medical input in the development and maintenance of RMPs for assigned product(s)
Provide medical input for the Reference Safety Information (RSI) for assigned product(s)
Contribute/lead, participate and support Benefit-Risk Team meetings for assigned project(s) and product(s)
Provide safety input in study protocols, study reports or high-level summary documents for regulatory filings for assigned project(s) or product(s)
Prepare and present safety data for Data Monitoring Committees for specified project(s) or product(s)
Completion of an accredited medical or surgical residency program is required. High level of medical competence with an ability to balance this with industry standards.
A minimum of 5+ years of experience in a medical review role in the pharmaceutical industry with a strong understanding of relevant regulatory requirements.
Prior experience in Oncology is preferred.Significant clinical experience (~ 5 years) may compensate for shorter experience in pharmaceutical/biotech company
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
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.
Designs and implements solutions to address project level challenges, taking into consideration the broader impact
We require that all recruiters and staffing agencies have a signed contract on file and be assigned a specific search by our human resources department.
Any resumes submitted through the website or directly by recruiters or staffing agencies that do not meet the above-mentioned criteria will be considered unsolicited and the company will not be responsible for any related fees.
#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.
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.
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