Clinical Safety Associate, Genentech
Job Title: Clinical Safety Associate
Company: Genentech
Status: Full Time
Years of Experience:
Location: South San Francisco, CA
Description:
For over 30 years, Genentech has been at the forefront of the biotechnology industry, using human genetic information to discover, develop, commercialize and manufacture biotherapeutics that address significant unmet medical needs.
The Clinical Safety Associate I (CSA I) is a member of the Drug Safety Department and working within a project team structure. The CSA I is primarily responsible for reviewing routine serious adverse event (SAE) reports from clinical trials (CT) and post marketing spontaneous reports for an assigned project. The CSA I is responsible for completeness and clarity, defining and initiating follow-up through the appropriate channels, participating in the triage of these reports for regulatory reporting purposes and facilitating communication with the Medical Affairs Clinical Team review of individual clinical trial and postmarking SAE reports. Demonstrates basic knowledge of safety concepts, focused on standards set out in ICH and FDA guidelines for drug safety reporting requirements. Demonstrates proficiency in case triage for a project molecule and serves as a back up for additional projects with the appropriate experience per SOPs and project coding guidelines. Appropriately identifies proper case regulatory reporting requirement with assistance from a senior CSA or Scientist. Identifies and utilizes resources and support available for adverse event triage and management. Applies Good Clinical Practices (GCP) documentation of phone, electronic, and/or fax correspondence regarding case follow-up information. Competently initiates and codes cases in the safety database based on SOPs. Identifies pertinent clinical information in adverse event reports and incorporate information in narrative field per standard narrative template. Identifies and enters relevant follow-up information in appropriate data and narrative fields per SOPs. Performs basic searches for data queries within the safety database. Assists in the preparation of expedited reports to regulatory agencies and partner companies including 15-day Alert reports, IND Safety Reports, and Serious, Labeled Expedited Reports. Assists in the preparation of U.S. Periodic Reports and International Periodic Safety Update Reports. Participates in discussions with requesting clinicians/consumers regarding drug safety information with the guidance/support of senior staff. Demonstrates general understanding of purpose of meetings for department, division, and appropriate molecule related projects, and attends as appropriate.
Requirements:
RN, BSN, NP, PA, MSN, RPh, Pharm D, or other applicable Health professional degree preferred. Clinical experience in a Health Care-related field. Previous experience in Clinical Safety or Drug Safety preferred. Computer proficiency in word processing, e-mail, spreadsheet applications, and applications of relational databases preferred. Attentive to detail. Excellent communication and interpersonal skills.
Genentech offers one of the most comprehensive benefits packages in the industry. Our culture emphasizes working hard, collaborating and sharing rewards. Our employees enjoy an environment that supports a work-life balance through benefits and programs that include sabbaticals, near-site childcare and concierge services. You can apply by forwarding your resume to the provided e-mail address. You can also apply by visiting our website at www.gene.com/careers; reference Requisition #1000013261. This will allow you to create an account and store a resume for application to Genentech positions. We are an equal opportunity employer.
Contact Email: genentechinternet@gene.com
Contact Phone: 650-225-1000
Company: Genentech
Status: Full Time
Years of Experience:
Location: South San Francisco, CA
Description:
For over 30 years, Genentech has been at the forefront of the biotechnology industry, using human genetic information to discover, develop, commercialize and manufacture biotherapeutics that address significant unmet medical needs.
The Clinical Safety Associate I (CSA I) is a member of the Drug Safety Department and working within a project team structure. The CSA I is primarily responsible for reviewing routine serious adverse event (SAE) reports from clinical trials (CT) and post marketing spontaneous reports for an assigned project. The CSA I is responsible for completeness and clarity, defining and initiating follow-up through the appropriate channels, participating in the triage of these reports for regulatory reporting purposes and facilitating communication with the Medical Affairs Clinical Team review of individual clinical trial and postmarking SAE reports. Demonstrates basic knowledge of safety concepts, focused on standards set out in ICH and FDA guidelines for drug safety reporting requirements. Demonstrates proficiency in case triage for a project molecule and serves as a back up for additional projects with the appropriate experience per SOPs and project coding guidelines. Appropriately identifies proper case regulatory reporting requirement with assistance from a senior CSA or Scientist. Identifies and utilizes resources and support available for adverse event triage and management. Applies Good Clinical Practices (GCP) documentation of phone, electronic, and/or fax correspondence regarding case follow-up information. Competently initiates and codes cases in the safety database based on SOPs. Identifies pertinent clinical information in adverse event reports and incorporate information in narrative field per standard narrative template. Identifies and enters relevant follow-up information in appropriate data and narrative fields per SOPs. Performs basic searches for data queries within the safety database. Assists in the preparation of expedited reports to regulatory agencies and partner companies including 15-day Alert reports, IND Safety Reports, and Serious, Labeled Expedited Reports. Assists in the preparation of U.S. Periodic Reports and International Periodic Safety Update Reports. Participates in discussions with requesting clinicians/consumers regarding drug safety information with the guidance/support of senior staff. Demonstrates general understanding of purpose of meetings for department, division, and appropriate molecule related projects, and attends as appropriate.
Requirements:
RN, BSN, NP, PA, MSN, RPh, Pharm D, or other applicable Health professional degree preferred. Clinical experience in a Health Care-related field. Previous experience in Clinical Safety or Drug Safety preferred. Computer proficiency in word processing, e-mail, spreadsheet applications, and applications of relational databases preferred. Attentive to detail. Excellent communication and interpersonal skills.
Genentech offers one of the most comprehensive benefits packages in the industry. Our culture emphasizes working hard, collaborating and sharing rewards. Our employees enjoy an environment that supports a work-life balance through benefits and programs that include sabbaticals, near-site childcare and concierge services. You can apply by forwarding your resume to the provided e-mail address. You can also apply by visiting our website at www.gene.com/careers; reference Requisition #1000013261. This will allow you to create an account and store a resume for application to Genentech positions. We are an equal opportunity employer.
Contact Email: genentechinternet@gene.com
Contact Phone: 650-225-1000
posted by Alex at
5:46 PM
