Director, Pharmacovigilance

Rigel Pharmaceutical, Inc.; South San Francisco (CA); On-site; USD 265,000 - 310,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Bonus program eligible

Equity incentive awards

401k plan

Paid time off

Paid company holidays

Other benefits

Job summary

Rigel Pharmaceuticals, Inc. is seeking a Director of Pharmacovigilance to lead the Drug Safety and Pharmacovigilance function, shaping safety strategy, governance, and regulatory compliance across development and marketed products; reports to the EVP, Chief Medical Officer.

This role oversees safety data analysis, signal detection, medical review of safety reports, and preparation of regulatory submissions; collaborates with Clinical Development, Regulatory Affairs, Medical Affairs, Quality,

Qualifications

• MD required; active US medical license preferred.
• Minimum 10 years of progressive drug safety and pharmacovigilance experience.
• Minimum 4 years in leadership roles with drug safety team management.
• Demonstrated expertise in oncology drug development and precision medicine approaches.
• Experience with novel therapeutic modalities including targeted therapies and biomarker driven development.

Responsibilities

• Lead safety governance, including escalation and resolution of significant safety issues.
• Oversee medical review of safety reports and regulatory safety submissions.
• Provide strategic direction for pharmacovigilance operations and safety systems.
• Collaborate with Clinical Development, Regulatory Affairs, Medical Affairs, and QA to align safety activities with company objectives.
• Lead inspection readiness and engagement with regulatory authorities.

Skills

Leadership

Oncology expertise

Regulatory knowledge

Cross-functional collaboration

Biomarker data in safety monitoring

Education

MD

Job description

POSITION SUMMARY

The Director Pharmacovigilance provides strategic and operational leadership for Rigels Drug Safety and Pharmacovigilance function The role is accountable for the safety strategy governance medical oversight regulatory compliance and continuous improvement of safety activities across Rigels development and marketed product portfolio Reporting to the EVP Chief Medical Officer this leader sets and executes pharmacovigilance strategy; establishes scalable safety processes and governance; and directs the assessment communication and management of product risk including safety surveillance and signal detection The Director partners closely with Clinical Development Regulatory Affairs Medical Affairs Quality Biostatistics Alliance Management and external stakeholders to ensure that safety decisions are scientifically sound compliant timely and aligned with Rigels corporate and patient care objectives Regular onsite presence is required to support cross functional collaboration team engagement and business operations Employees designated as onsite or hybrid who reside within the local commuting area are expected to work onsite at Rigels South San Francisco headquarters during normal business hours each Wednesday and Thursday Employees designated as remote are expected to work onsite during normal business hours for a minimum of two WednesdayThursday business day periods per month as scheduled with management and more frequently as business needs require

ESSENTIAL DUTIES AND RESPONSIBILITIES

Pharmacovigilance Leadership Own the Pharmacovigilance operating model including strategic planning policies procedures systems quality metrics and continuous process improvement Establish and lead safety governance including escalation and resolution of significant safety issues benefit risk positions and risk management recommendations Provide medical and scientific oversight of safety assessments including individual and aggregate safety data emerging signals and product risk profiles Lead and develop Pharmacovigilance staff and provide functional direction coaching and oversight to external service providers and CRO partners Own vendor governance including service delivery performance management compliance and issue escalation Lead inspection and audit readiness for Pharmacovigilance activities including investigation remediation and CAPA oversight Oversee business partner relationships including attendance at Joint Steering Committee meetings and construction of Pharmacovigilance Agreements Oversee medical review of aggregate safety data in standardized regulatory reports including Investigator Brochures Development Safety Update Reports Periodic Benefit Risk Evaluation Reports and Periodic Safety Update Reports to ensure a balanced medically sound presentation and timely identification of potential product risks Annual review of Risks section of all Rigel product Informed Consents Oversee medical review of Individual Case Safety Reports (ICSRs) including causality seriousness expectedness coding quality narratives and case series evaluations ensuring appropriate medical judgment and regulatory compliance Oversee preparation review and timely submission of expedited and periodic safety reports aggregate reports and safety content for protocols clinical study reports and regulatory submissions Direct the set up of new safety projects including study specific Safety Management Plans and safety systems and processes as needed Expert Safety Data Analysis & Signal Management Lead evaluation of complex drug safety data to identify safety signals and evaluate signals for evidence of causal association with precision oncology products applying advanced analytical techniques and clinical judgment Conduct sophisticated signal detection activities using advanced tools and methodologies integrating preclinical clinical and literature data sources Advanced Safety Document Authoring & Review Lead preparation of complex summary drug safety evaluations including IND Annual Reports PADERs DSURs PSURs and integrated safety summaries for precision oncology programs Author and review safety sections of clinical study reports protocols and regulatory submissions with advanced understanding of oncology safety considerations Strategic Department Operations & Policy Development Lead departmental operations including procedural strategies training programs service provider management inspection readiness and audit support Establish and maintain departmental policies business strategies and procedural compliance with corporate requirements and global pharmacovigilance regulations Cross Functional Leadership & Stakeholder Management Serve as the primary Pharmacovigilance liaison with therapeutic leads Drug Safety physicians biostatisticians and other key stakeholders on critical programs and safety matters Represent Pharmacovigilance in cross functional and senior leadership forums providing strategic guidance on complex safety benefit risk and regulatory matters Complex Problem Solving & Innovation Apply extensive knowledge of drug safety disease specific clinical knowledge and business objectives to solve significant problems in creative and effective ways Lead innovative approaches to safety monitoring for novel therapeutic modalities including ADCs and precision medicine programs

KNOWLEDGE AND SKILL REQUIREMENTS

MD required; active US medical license preferred Minimum 10 years of progressive drug safety and pharmacovigilance experience in the biopharmaceutical industry Minimum 4 years in leadership roles with drug safety team management andor functional leadership responsibility Demonstrated expertise in oncology drug development and precision medicine approaches Experience with novel therapeutic modalities including targeted therapies and biomarker driven development Deep knowledge of global pharmacovigilance regulations ICH FDA EMA GVP and precision medicine guidance Extensive experience with regulatory submissions for complex oncology products Advanced expertise in safety signal detection methodologies and benefit risk assessment frameworks Experience integrating biomarker data into safety monitoring and risk management strategies Proven ability to influence and collaborate with cross functional stakeholders Excellent written and verbal communication skills with ability to present complex safety concepts Demonstrated experience interfacing with regulatory authorities on safety matters and leading inspection or audit readiness activities Previous biotechpharmaceutical industry experience with marketed products as well as demonstrated ability to lead and develop staff and external safety partners

COMPENSATION AND BENEFITS

The anticipated salary range for this position is 265000 to 310000 The actual salary offered will depend on several factors including experience qualifications geographic location internal equity and business needs This position is eligible to participate in Rigels annual bonus program and is eligible for equity incentive awards subject to the terms of the applicable plans This position is not commission based Rigel offers eligible employees a comprehensive benefits package including medical dental and vision coverage; life and disability insurance; flexible spending accounts; a 401k plan; paid time off; paid company holidays; and other benefits

• medical dental and vision coverage
• life and disability insurance
• flexible spending accounts
• a 401k plan
• paid time off
• paid company holidays
• other benefits

WORKING CONDITIONS PHYSICAL DEMANDS

While performing the duties of this job the employee is required to stand walk; sit; talk and hear Specific vision abilities required by this job include close vision distance vision peripheral vision depth perception and the ability to adjust focus

WORK ENVIRONMENT

The noise level in the work environment is usually moderate Some travel may be required Rigel Pharmaceuticals Inc is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity genetic information national origin protected veteran status disability status or any other characteristic protected by the law