Pharmacovigilance ICSR Scientist

The Opportunity

This role can be fully remote.

The Pharmacovigilance (PV) ICSR Scientist is responsible for tactical and operational PV activities, including but not limited to the collection, clinical review, evaluation, and processing of adverse event (AE) information received by US Patient Safety (US PS). The PV ICSR Scientist manages clinical review of USPS cases (processed in-house or externally by vendor) and supports the US PS PV Clinical management in all activities. All responsibilities are performed under the direction of the PV Clinical ICSR Manager.

Demonstrates high-level proficiency and expertise of drug safety concepts to include monitoring, tracking, and completion in a timely, thorough and accurate manner in accordance with pharmacovigilance (PV) related standards, regulations and Genentech/Roche Standard Operating Procedures (SOPs).

Key Responsibilities

• Work alongside a diverse team of healthcare professionals (e.g., RN, PharmD, MD), provide guidance as needed, and act as the single point of contact with key stakeholders for safety-related activities.

• Demonstrate proficiency in regulatory guidelines for managing ICSRs (FDA, EMA, ICH - GVP), and participate in health authority inspections and license partner audits as required.

• Handle changing priorities professionally, meet deadlines under pressure, and ensure ICSR quality aligns with company standards. Make independent decisions on operational activities and escalate issues appropriately.

• Contribute to the creation and implementation of organizational strategies and business plans for PV Clinical. Participate in interactions with Global Drug Safety and other affiliates, addressing safety queries and discussing new regulations.

• Oversee ICSR activities and safety commitments, assist in vendor oversight, and ensure successful completion of all role-specific training. Coordinate with USMA Compliance for regulatory inspections and act as a Subject Matter Expert (SME) for safety activities per Genentech/Roche SOPs.

Who you are

Required Qualifications & Experience

• Health Care Professional (HCP) or individuals with Master's degree with relevant pharmaceutical industry experience in Pharmacovigilance

• Minimum of 1 year recent experience in the pharmaceutical industry including strong ICSR process experience

• Knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations.

• Understanding of and/or previous experience with Phase I - III and/or Phase IV drug development

• Some experience in the principles and techniques of data analysis, interpretation and clinical relevance, medical writing

Preferred Experience

• Knowledge of EMEA regulations

• Proven record in developing strong relationships with external constituents (therapeutic area experts, external organizations, etc.)

The expected salary range for this position based on the primary location of South San Francisco, 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 provided below.

Benefits

Relocation benefits are not available for this job posting.

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.

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.