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Form of workThe Position
Genentech, Inc. seeks a Pharmacovigilance Clinical Scientist-Product in its South San Francisco, California location.
Duties: Complete drug safety monitoring and tracking in a timely, thorough and accurate manner in accordance with pharmacovigilance (PV) and related standards, regulations and company Standard Operating Procedures (SOPs). Provide subject matter expertise and clinical review for case processing (in-house and by vendors) to ensure Individual Case Safety Report (ICSR) quality within Pharmacovigilance Clinical Team. Assess seriousness, validity, and causality and conduct quality review of cases as applicable, perform follow up communication to relevant Health Care Professionals for all reported cases and ensure appropriate data correction in the safety database for identified errors. Apply clinical knowledge and expertise with appropriate labeling documents for molecules and products to perform labelling assessment for Adverse Events (AE) received. Provide PV support to study molecule teams for investigational drug molecules including Protocol review, Post Authorization Safety Assessment (PASS) classification, Safety Management Plane (SMP) review, Safety Data Exchange Agreement (SDEA) review, and Serious Adverse Event (SAE) reconciliations. Perform review of Suspected Unexpected Serious Adverse Reactions (SUSAR) and coordinate safety aspects of health authority submissions applying thorough understanding of Food and Drug Administration (FDA) regulations. Review investigational new drug safety reports (INDSR) and submission to FDA as applicable. Implement internal manuals, global and local safety Standard Operating Procedures (SOP), work instructions applicable to United States Patient Safety organization, and external collaboration agreements, e.g., Pharmacovigilance Agreements (PVA) and Safety Data Exchange Agreement (SDEA). Actively participate as a member of the Study Management Team and perform PV activities including: providing drug safety presentations for various meetings, acting as a single point of contact for safety related concerns, and acting as a safety liaison between Clinical Safety, Study Review Team (SRT), Study Management Team (SMT), and any similar governing bodies. Review and monitor signal detection and validation for aggregate data received by United States Patient Safety, including Periodic Benefit-Risk Evaluation Report (PBRER) and Periodic Safety Update Reports (PSUR). Review and implement pharmacovigilance agreements (PVA) with business partners during launch of new medicinal product, review Safety Data Exchange Agreements (SDEA), review protocols for Clinical Study, etc. Responsible for health authority requests, and audit/inspection related activities including reconciliation of Case Transmission Verification (CTV). Collaborate with Pharmacovigilance Operations and Service Provider Pharmacovigilance Oversight (SPPV) teams to train internal or vendor staff on trend analysis. Provide insights on case processing activities, and perform trend analysis using data analysis tools.
Education and experience required: Doctor of Pharmacy (PharmD), Doctor of Medicine (MD), Doctor of Surgery (DS)/Dental Surgery (DDS), or related professional degree (or foreign equivalent), in Medicine, Surgery, Pharmacy, Pharmacology or related healthcare field, or foreign equivalent degree, and one (1) year of experience in the job offered or as Drug Safety Specialist, Safety Operations Advisor, Pharmacovigilance Associate/Scientist, Pharmacist, or related position.
Special Requirements: Must have 1 year of experience with:
May telecommute up to 2 days a week.
Worksite: 1 DNA Way South San Francisco, California, 94080.
The expected salary range for this position based on the primary location for this position of California is $154,128.00 to $208,500.00 per year. Actual pay within the range will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits (https://roche.ehr.com/default.ashx?CLASSNAME=splash )
Who we are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We're focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.
Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. For more information about equal employment opportunity, visit our Genentech Careers Homepage.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
Genentech, Inc. seeks a Pharmacovigilance Clinical Scientist-Product in its South San Francisco, California location.
Duties: Complete drug safety monitoring and tracking in a timely, thorough and accurate manner in accordance with pharmacovigilance (PV) and related standards, regulations and company Standard Operating Procedures (SOPs). Provide subject matter expertise and clinical review for case processing (in-house and by vendors) to ensure Individual Case Safety Report (ICSR) quality within Pharmacovigilance Clinical Team. Assess seriousness, validity, and causality and conduct quality review of cases as applicable, perform follow up communication to relevant Health Care Professionals for all reported cases and ensure appropriate data correction in the safety database for identified errors. Apply clinical knowledge and expertise with appropriate labeling documents for molecules and products to perform labelling assessment for Adverse Events (AE) received. Provide PV support to study molecule teams for investigational drug molecules including Protocol review, Post Authorization Safety Assessment (PASS) classification, Safety Management Plane (SMP) review, Safety Data Exchange Agreement (SDEA) review, and Serious Adverse Event (SAE) reconciliations. Perform review of Suspected Unexpected Serious Adverse Reactions (SUSAR) and coordinate safety aspects of health authority submissions applying thorough understanding of Food and Drug Administration (FDA) regulations. Review investigational new drug safety reports (INDSR) and submission to FDA as applicable. Implement internal manuals, global and local safety Standard Operating Procedures (SOP), work instructions applicable to United States Patient Safety organization, and external collaboration agreements, e.g., Pharmacovigilance Agreements (PVA) and Safety Data Exchange Agreement (SDEA). Actively participate as a member of the Study Management Team and perform PV activities including: providing drug safety presentations for various meetings, acting as a single point of contact for safety related concerns, and acting as a safety liaison between Clinical Safety, Study Review Team (SRT), Study Management Team (SMT), and any similar governing bodies. Review and monitor signal detection and validation for aggregate data received by United States Patient Safety, including Periodic Benefit-Risk Evaluation Report (PBRER) and Periodic Safety Update Reports (PSUR). Review and implement pharmacovigilance agreements (PVA) with business partners during launch of new medicinal product, review Safety Data Exchange Agreements (SDEA), review protocols for Clinical Study, etc. Responsible for health authority requests, and audit/inspection related activities including reconciliation of Case Transmission Verification (CTV). Collaborate with Pharmacovigilance Operations and Service Provider Pharmacovigilance Oversight (SPPV) teams to train internal or vendor staff on trend analysis. Provide insights on case processing activities, and perform trend analysis using data analysis tools.
Education and experience required: Doctor of Pharmacy (PharmD), Doctor of Medicine (MD), Doctor of Surgery (DS)/Dental Surgery (DDS), or related professional degree (or foreign equivalent), in Medicine, Surgery, Pharmacy, Pharmacology or related healthcare field, or foreign equivalent degree, and one (1) year of experience in the job offered or as Drug Safety Specialist, Safety Operations Advisor, Pharmacovigilance Associate/Scientist, Pharmacist, or related position.
Special Requirements: Must have 1 year of experience with:
- Clinical safety review of patient profiles;
- ICSR Case Management and Trend Analysis;
- Safety Reporting Processes for adverse events;
- Review of aggregate reports;
- Health authority submissions, including SUSAR review
- Clinical and safety databases.
May telecommute up to 2 days a week.
Worksite: 1 DNA Way South San Francisco, California, 94080.
The expected salary range for this position based on the primary location for this position of California is $154,128.00 to $208,500.00 per year. Actual pay within the range will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits (https://roche.ehr.com/default.ashx?CLASSNAME=splash )
Who we are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We're focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.
Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. For more information about equal employment opportunity, visit our Genentech Careers Homepage.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
