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Genentech, Inc. seeks a Senior PV Clinical Scientist - ICSR in its South San Francisco, California location.
Perform drug safety monitoring and tracking in accordance with pharmacovigilance (PV) and related standards, regulations and company's Standard Operating (SOPs). Act as a single-point-of-contact for individual case safety report (ICSR) PV compliance activities including providing drug safety presentations. Conduct clinical reviews for PV case processing initiatives to ensure quality standards are met for Individual Case Safety Reports (ICSR) within the PV Clinical Team. Monitor and provide recommendations on case processing activities, and perform trend analysis using data analysis tools. Assess disease seriousness, validity, and causality, and conduct quality review for all cases. Conduct follow-up communication with Healthcare Providers (HCPs) for all reported cases. 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 for drug molecule investigation and clinical trial development. Apply knowledge of FDA regulations to review Suspected Unexpected Serious Adverse Reactions (SUSAR) and investigational new drug safety reports (INDSR); review and coordinate related health authority submissions. Manage inquiries from health authorities, and provide audit/inspection support. Review, create, and implement processes to meet pharmacovigilance agreements (PVA) with business partners during new product launch inspections/audit. Review, create, and implement processes to meet new health authority regulations as set forth by regulatory authorities. Facilitate safety-related communication among governing bodies. May manage up to 4 PV Clinical Associates (contractors or junior scientists). Telecommuting is permitted up to 2 days per week.
Education and experience required: Master's degree in Pharmacy, Pharmacology, Pharmaceutical Science, Medicine/Medical Science, or a related healthcare field, or foreign equivalent, and 3 years of experience in the job offered or as Drug Safety Specialist, Pharmacovigilance Associate/Scientist, Pharmacist, or related position.
Special Requirements: Must have 3 years experience with:
The expected salary range for this position based on the primary location for this position of California is $180,630 to $269,900 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)
Worksite: 1 DNA Way, South San Francisco, California, 94080, United States
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 Senior PV Clinical Scientist - ICSR in its South San Francisco, California location.
Perform drug safety monitoring and tracking in accordance with pharmacovigilance (PV) and related standards, regulations and company's Standard Operating (SOPs). Act as a single-point-of-contact for individual case safety report (ICSR) PV compliance activities including providing drug safety presentations. Conduct clinical reviews for PV case processing initiatives to ensure quality standards are met for Individual Case Safety Reports (ICSR) within the PV Clinical Team. Monitor and provide recommendations on case processing activities, and perform trend analysis using data analysis tools. Assess disease seriousness, validity, and causality, and conduct quality review for all cases. Conduct follow-up communication with Healthcare Providers (HCPs) for all reported cases. 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 for drug molecule investigation and clinical trial development. Apply knowledge of FDA regulations to review Suspected Unexpected Serious Adverse Reactions (SUSAR) and investigational new drug safety reports (INDSR); review and coordinate related health authority submissions. Manage inquiries from health authorities, and provide audit/inspection support. Review, create, and implement processes to meet pharmacovigilance agreements (PVA) with business partners during new product launch inspections/audit. Review, create, and implement processes to meet new health authority regulations as set forth by regulatory authorities. Facilitate safety-related communication among governing bodies. May manage up to 4 PV Clinical Associates (contractors or junior scientists). Telecommuting is permitted up to 2 days per week.
Education and experience required: Master's degree in Pharmacy, Pharmacology, Pharmaceutical Science, Medicine/Medical Science, or a related healthcare field, or foreign equivalent, and 3 years of experience in the job offered or as Drug Safety Specialist, Pharmacovigilance Associate/Scientist, Pharmacist, or related position.
Special Requirements: Must have 3 years experience with:
- Study Management
- ICSR Case Management and Trend Analysis
- Health authority submissions, including SUSAR review
- Clinical and safety databases
- Phase I - III and/or Phase IV drug development
The expected salary range for this position based on the primary location for this position of California is $180,630 to $269,900 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)
Worksite: 1 DNA Way, South San Francisco, California, 94080, United States
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.
