Are you a Pharmacovigilance auditor with an interest in performing risk assessments and developing quality strategies for assigned areas? Or are you a Pharmacovigilance expert who wants to gain auditing experience? If so, then this is the role for you!

The Opportunity

In Pharma Development Quality (PDQ) we strive for confidence in the integrity of our data and our processes, agility, and unrivaled transparency with health authorities, patients and society. Our work provides leadership, know-how and partnering on quality across Molecules, Products (Drug and/or Medical Devices), Pharma affiliates and global regulated processes.

We are looking for a Quality Lead (Pharmacovigilance Auditor) who brings a diversity of thinking and technical experience in pharmacovigilance / drug safety. The Quality Lead (Pharmacovigilance Auditor) will support the Roche/Genentech Organization through the design and delivery of pharmacovigilance related quality strategies. Quality strategies will have defined quality measures (critical to quality [CtQ] factors) and objectives based on business surveillance and the use of data analytics. The Quality Lead(Pharmacovigilance Auditor) will generate evidence and actionable data through the conduct of audits to assess the quality status and to be able to demonstrate effective implementation of quality assurance to stakeholders and Health Authorities. 

Key Responsibilities

• Define process/affiliate level approach with appropriate measures (CtQ factors) to enable oversight and management of quality 

• Design and implement quality strategies for the assigned PV related area (affiliates/PV process)

• Assess specific pharmacovigilance related risk areas on an ongoing basis, communicate to PDQ senior leadership and propose modifications to the quality strategy where necessary

• Actively lead or contribute in activities to assess quality status, including preparation, conduct, presentation and timely reporting of outcomes of audits, ensuring appropriate action plans are developed 

• Establish strong partnerships/relationships with business stakeholders

• Prepare and present contextualized quality evidence, including conclusions, observations and associated compliance risks to business stakeholders and Pharma representatives 

• Lead or support inspection preparation activities and management of Health Authority inspections 

Who you are

Your Profile

• You are a highly motivated and committed professional with strong experience and technical knowledge in pharmacovigilance.

• You have proven critical thinking and problem solving skills (curiosity, creativity and adaptability), with solid relationship management and influence. You ask the challenging questions and are comfortable in difficult conversations.

• You have an in-depth understanding of the drug development process.

Required

• Masters, Bachelor’s degree or equivalent in scientific or quality-related field or equivalent combination of education, training and experience

• Minimum 5 years in the pharmaceutical industry and/or pharmacovigilance experience

• Demonstrated applied knowledge of pharmacovigilance / drug safety and regulatory requirements

• Demonstrated excellent analytical, strategic thinking, and problem-solving skills with a proven ability to understand business impact

• Excellent verbal and written communication and stakeholder management skills

• Project management experience with proven leadership, mentoring and coaching

Desired

• Proficiency in the conduct of GxP audits

• Experience supporting Health Authority inspections

• Proficiency in utilizing data and visualisation tools to generate insights

Your Application:

Please kindly provide a cover letter alongside your CV.

The interview process will consist of a screening video interview, followed by a case study presentation as part of the interview process.

Relocation benefits are not available for this job posting.

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