Senior Manager, Drug Safety

Role Summary

Senior Manager Drug Safety & Pharmacovigilance (DSPV) will serve as a subject matter expert for drug safety activities across Rigel’s portfolio. This role requires expertise in drug development as well as clinical trial and post marketing pharmacovigilance activities. The Senior Manager DSPV Operations will independently manage the operational activities internally and with a third-party pharmacovigilance contract vendor responsible for processing of adverse events from clinical trials and post marketing safety data sources. The Senior Manager DSPV Operations will ensure the pharmacovigilance activities are performed in compliance with DSPV SOPs and procedures, best industry standards, and applicable regulations.

Responsibilities

• Safety Data Management - Case Processing and Aggregate Reports
  • Participates in the review and execution of DSPV operations related to safety data collection and processing for Rigel clinical trial and post marketed programs.
  • Leads preparation of summary drug safety evaluations, including IND Annual Reports, PADERs, DSURs, PSURs, and integrated safety summaries.
  • Authors and reviews safety sections of clinical study reports, protocols, and regulatory submissions.
• Quality Management
  • Maintains knowledge of adverse event reporting processes and safety systems.
  • Contributes to the development, implementation, improvement, and standardization of new processes, methods, and databases.
  • Participates in the quality review of serious AEs and expedited submissions to regulatory authorities following data entry by vendor with specific focus on accuracy of narrative to reflect source documentation, MedDRA coding, and appropriateness of queries to seek follow-up from reporters.
  • Participates in authoring and quality checks of periodic safety reports (e.g., DSUR, PSUR, IND annual reports).
  • Authors governing documents, such as standard operating procedures, work instructions and safety management plans.
  • Participates in the quality management system ensuring department standards are met, including training requirements, monitoring performance, implementing continuous improvement actions and good documentation practices.
• Compliance & Inspection Readiness
  • Monitors compliance with regulations, pharmacovigilance agreements and internal standard operating procedures.
  • Works to maintain a state of high inspection readiness.
  • Participates in internal audits and global regulatory inspections including specific pharmacovigilance topics and processes.
  • Contributes to formal responses to inspection and audit findings related to DSPV department.
• Signal Detection & Risk Management
  • Provides safety operations support in signal detection and risk management activities.
  • Contributes to the evaluation of complex drug safety data to identify safety signals and evaluate signals for evidence of causal association using analytical methods and clinical judgment.
  • Conducts signal detection activities using tools and methodologies per direction of DSPV management.
• Vendor & Business Management
  • Independently manages the pharmacovigilance vendors outsourced clinical trial and post marketing surveillance activities.
  • Provides sponsor oversight of adverse events (AEs) processing by vendors, including the review and monitoring of compliance through monitoring reports and oversight activities.
  • Collaborates with contract service providers regarding adverse event reporting.
  • Ensures compliant exchange of safety data between Rigel and its business partners and vendors.
• Leadership and Team Contribution
  • Directly manages internal safety operations personnel as applicable.
  • Assists in performing additional ad hoc activities as assigned.
  • Serve as liaison with therapeutic leads and key stakeholders on projects requiring safety expertise.
  • Represent DSPV in cross-functional clinical team meetings, providing guidance on safety activities.
  • Collaborate with Rigel personnel from other functional areas on process, company initiatives, and programs as required.
  • Participates in the creation and dissemination of appropriate safety reporting language in key documents pertaining to clinical trial and post marketing management of safety data.
• Complex Problem Solving & Innovation
  • Applies knowledge of drug safety to creatively and effectively solve problems.
  • Lead innovative approaches to monitor the safety of Rigel medicinal products.

Qualifications

• Required: Bachelor's degree in nursing, pharmacy, or other health care related profession or life sciences preferred or equivalent qualification/work experience.
• Required: Minimum of 3-5 years of experience in Drug Safety/Pharmacovigilance in a pharmaceutical industry setting or the equivalent.
• Required: Minimum of 2 years of experience managing third-party Pharmacovigilance vendors, CROs, and business alliance relationship management.
• Required: Minimum of 2 years managing direct reports.
• Preferred: Global pharmacovigilance operations experience with medicinal products in development and commercial use.
• Preferred: Knowledge of relevant regulations, guidance, and industry standards governing adverse event processing and reporting from clinical trials and/or post marketing surveillance.
• Preferred: Experience working with safety databases and systems.
• Preferred: Experience with MedDRA coding and data entry.
• Preferred: Strong analytical and problem-solving skills with superb attention to detail.
• Preferred: Strong verbal, written technical communication and presentation skills.
• Preferred: Works effectively/collaboratively in a fast-paced team environment and with individuals at all levels within an organization.
• Preferred: Proven ability to work within a cross-functional, matrixed team with the ability to manage multiple tasks with competing timelines.
• Preferred: Deep knowledge of global pharmacovigilance regulations (ICH, FDA, EMA, GVP).
• Preferred: Extensive experience with regulatory submissions for drugs and biologics.
• Preferred: Expertise in safety signal detection methodologies and benefit-risk assessment frameworks.
• Preferred: Excellent written and verbal communication skills.
• Preferred: Proven ability to present complex safety concepts.
• Preferred: Proven ability to clearly present safety issues, identify solution strategies, and develop the specific resolution based on team consensus.
• Preferred: Experience interfacing with regulatory authorities on safety matters.

Education

• Bachelor's degree in nursing, pharmacy, or life sciences preferred or equivalent qualification/work experience.

Additional Requirements

• Some travel may be required.