- Lead the development, governance, and improvement of pharmacovigilance (PV) systems, including enhancing CRO relationships, managing outsourced activities, and ensuring the delivery of PV-related deliverables.
- Establish and oversee Drug Safety Standard Operating Procedures, contributing to the development, configuration, and validation of a safety database.
- Conduct comprehensive analyses of adverse events, literature, and other safety-relevant data for signal detection and safety data management.
- Provide expert medical writing and review support for drug safety sections of critical documents such as protocols, Informed Consent Forms (ICFs), Investigator Brochures (IBs), Clinical Study Reports (CSRs), safety management plans, and aggregate safety reports (e.g., DSURs, Annual Reports).
- Assist in the formation of a safety governance structure, leading safety surveillance, risk management planning, and the oversight of safety risk mitigation strategies.
- Collaborate with cross-functional teams including Clinical Development, Regulatory Affairs, and Quality to ensure appropriate reporting of PV and drug safety information and support risk mitigation measures.
- Monitor industry best practices and regulatory changes globally to inform strategic direction and maintain compliance.
- Coordinate responses to safety inquiries from regulatory authorities, manage resolutions of issues from audits and inspections, and lead corrective action plans.
- Provide dynamic leadership in patient safety and pharmacovigilance risk management activities, ensuring a proactive and ongoing assessment of data to inform safety strategies and maintain a positive benefit-risk profile.
- Lead multidisciplinary Safety Review Committees (SRC) responsible for safety surveillance, risk management planning, and communication plan recommendations.
- Design, evaluate, implement, and oversee Risk Evaluation and Mitigation Strategies (REMS), Risk Management Plans, and Post-Approval Safety Surveillance initiatives in partnership with cross-functional teams.
- Contribute to the development and review of a wide range of clinical, regulatory, and scientific documents, ensuring safety content is harmonized and meets regulatory standards.
- Candidates for the Director level typically hold a master's or RN degree combined with approximately 8+ years of experience in Pharmacovigilance (PV) / drug safety. For the Senior Director level, candidates should have an advanced degree (MD, DO, Ph.
- Demonstrated proficiency in strategizing, planning, and monitoring with exceptional problem-solving capabilities.
- The flexibility to prioritize tasks effectively in a fast-paced environment, with a strong ability to adapt to setbacks and manage competing priorities.
- Team-oriented with proven ability to work collaboratively with both internal colleagues and external vendors.
- Experience as a safety lead for an asset or approved drug product, including responsibility for PV documents (e.g., DSUR/PBRER, IB and ICF safety sections, risk management strategies, and plans).
- Working knowledge of industry-standard safety databases (e.g., ARGUS, ARISg) and proficiency with other electronic data capture systems.
- Comprehensive understanding of the drug development process, including clinical trial methodology, medical terminology, and the principles of clinical assessment of adverse events (AEs).
- Proven experience in reviewing cumulative safety data, with the ability to interpret, synthesize, and communicate complex clinical/pharmaceutical information and safety data, alongside developing risk management/mitigation strategies.
- Experienced in supporting PV audits and/or health authority inspections.
- Demonstrated leadership skills with a track record of effective collaboration in a team environment across multiple functions (e.g., Clinical Development, Biometrics, Clinical Operations, Regulatory Affairs, Medical Affairs) and with external vendors and stakeholders.
- Exceptional organizational skills, capable of multitasking in an extremely fast-paced environment with shifting priorities.
- Excellent communication skills, with the ability to influence across multiple functions.
- Willingness to travel internationally/domestically as required.
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Director / Sr. Director Pharmacovigilance - South San Francisco, United States - Kezar Life Sciences
Description
Kezar is a clinical-stage biotechnology company developing breakthrough treatments for immune-mediated and oncologic disorders.Kezar's lead product candidate, zetomipzomib, is being evaluated in clinical trials for the treatment of lupus nephritis (LN) and autoimmune hepatitis (AIH).
Kezar is also conducting an oncology clinical trial of KZR-261, the first candidate from its novel platform targeting the protein secretion pathway.
We are searching for a Director or Sr. Director, Pharmacovigilance to oversee and manage the PV / drug safety function.
Remote candidates may be considered; however, the preference is for local candidates who can be onsite at our South San Francisco, CA office at least three days per week.
Key Responsibilities include:
Not sure if you are qualified for this position? We know that skills and experience can show up in different ways and we welcome resumes from a broad range of applicants.
Preferred Qualifications Include:
This role can be based at our South San Francisco, CA corporate office (preferred) or remote-based. The salary range for this Director position (non-MD) in South San Francisco, CA is $240,000 - $255,000. The salary range for this position at the Senior Director (non-MD) level is $305, ,000.
For remote-based candidates, the salary range will be based on the local market, which varies state to state and is typically 15% lower than the San Francisco Bay Area.
Additional factors such as academic credentials, especially candidates with an MD, and relevant experience will influence the actual salary offered.
In addition to a competitive market-based salary, Kezar Life Sciences offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package including 401K.
Additional information about our total rewards program can be found here:Join Our Team - Kezar Life Sciences Inc.
About Kezar Life Sciences
We are developing first-in-class, small molecule therapies designed to inhibit multiple disease-driving cellular pathways by targeting key intracellular proteins.
Since inception, our mission has been to deliver novel treatments that can better the lives of patients fighting difficult-to-treat chronic diseases.
Here at Kezar, our employees are our greatest asset and are the drivers of the Company's success.Every day, our team of passionate professionals are converting scientific ideas to first-in-class assets that have the potential for significant clinical impact in the most difficult-to-treat diseases.
Together, we are focused on the common mission of helping patients overcome their chronic conditions and live a better life.
We believe in fostering a culture of trust and respect for all team members at all levels. Our employees are encouraged to question, exchange views and discover new ways to address issues and solve problems. We welcome differences in ideas, styles and practices to accomplish our goals.Hard working, innovative and compassionate are qualities every Kezar employee should possess and we're always looking for equally dynamic and motivated individuals to join our team.
Information for Recruitment Agencies
Kezar Life Sciences does not accept from recruiters/agencies any unsolicited resumes, or any candidate information including blinded resumes and will not be responsible for any fees related to resumes or candidate information that is unsolicited.
Please do not contact hiring managers or Kezar Life Sciences employees directly with any information related to a resume or a candidate.
We handle all recruiting through our internal Human Resources team, and we will reach out to you directly should we wish to engage in a search.
Your willingness to comply with this will significantly impact any decision we may make about doing business with you.
Director / Sr. Director Pharmacovigilance professionals in South San Francisco
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