Operations & Innovations Associate

Who We Are

Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. 

The Opportunity

The Operations & Innovations Associate provides operational support to the US Patient Safety Clinical and Vendor Oversight teams to ensure proper performance of baseline PV compliance based responsibilities. This is done through implementation and regulation of global processes, local legislation, case investigation, and study management.

Key Responsibilities:

• ICSR Management: Oversee Individual Case Safety Reports (ICSR) activities, including outbound submission, compliance monitoring, workflow coordination, vendor onboarding, and global collaboration.

• Risk Mitigation: Support investigation and risk mitigation for late ICSRs through root cause analysis, corrective actions, compliance updates, trend reviews, and stakeholder collaboration.

• Study Management Support: Manage study activities including document review tracking, Case Transmission Verification (CTV), USMA study assessments, stakeholder engagement, compliance risk escalation, and metrics tracking.

• MAP Operational Activities: Ensure data integrity for Market Research Patient (MAP) support programs via reconciliations, Source Data QC (SDQC), operational metrics reports, and vendor management.

• PV and PRC Oversight: Oversee outsourced PV activities and the receipt/processing of pharmacovigilance activity classification (PVAC) requests, as well as review Promotional Review Committee (PRC) marketing materials for compliance and accuracy.

Additionally the Operations and Innovations Associate will be accountable for the following;

• Identify business gaps and assist in developing and implementing process solutions; continuously evaluate operational remit for process improvements and opportunities to consolidate or outsource PV activities.

• Participate in educating internal and external stakeholders on safety-related activities by creating and assigning required training; act as a subject matter expert and point of contact for audit/inspection activities.

• Manage special projects as assigned by US PS Leadership, including developing and managing detailed project schedules and scope of work.

Required Qualifications/Experience:

• Bachelor’s degree or 5-10 years PV experience

• Business Expertise: Possesses strong knowledge and expertise in the pharmacovigilance (PV) environment.

• Effective Collaboration: Works independently and collaboratively with effective interaction in multifunctional, multidisciplinary teams. Outstanding written and verbal communication skills, strong interpersonal skills, and extreme resourcefulness.

• Organizational Skills: Demonstrates strong organizational skills, attention to detail, and adaptability in a fast-paced, changing environment.

• Initiative and Accountability: Shows ownership, initiative, accountability, and the ability to prioritize and execute complex tasks in a timely manner to ensure compliance.

• Leadership and Communication: Exhibits leadership skills, effective knowledge exchange, and the ability to actively share ideas.

• Analytical and Decision Making Skills: Excellent analytical skills and sound decision-making abilities, including systematic information gathering, assessing issue complexity, and prioritizing tasks within the scope of responsibility in order to solve problems creatively and translate complex data trends into actionable steps. 

Preferred Qualifications/Experience:

• Degree in Life Science or related field

• Familiarity with project management software tools, methodologies, and best practices.

• Flexibility and Mobility: Ability to travel as required.

This position is based from our office in South San Francisco and offers a hybrid schedule working in-office 3 days per week. Relocation benefits are not available for this job posting. 

The expected salary range for this position based on the primary location of CA is $97,900 - $181,700. Actual pay 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: Benefits

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.