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Drug Safety Senior Director

Company: Rigel Pharmaceuticals, Inc.
Location: South San Francisco
Posted on: June 7, 2021

Job Description:

POSITION SUMMARY:

The Senior Director in Drug Safety is responsible for the functioning and performance of safety activities, both tactical and strategic, of the Pharmacovigilance (PV) and Drug Safety (DS) department at Rigel. This position is integral for development and assessment of drug safety processes including implications for company overall objectives. The Senior Director will be responsible for maintaining standards and processes with an emphasis on compliance. This individual must effectively interface cross-functionally at all levels in the organization as well as externally with investigators, vendors and regulatory authorities. He or she will report to the VP of Clinical Sciences and Drug Safety in developing PV strategy for senior management, in managing the safety assessment of products, including review of individual and aggregate AEs and the scientific literature, and in preparing safety reports and communicating changes in the product risk profile to internal and external stakeholders. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential.

ESSENTIAL JOB FUNCTIONS:

  • Oversee management of all safety vendors
  • Ensure that all safety reports received from any source (clinical or commercial) are processed and reported according to ICH-GCP guidelines, regulatory requirements and Rigel SOPs and procedures
  • Oversee Quality Control review of all cases to ensure accuracy, integrity and completeness of information entered in the safety database
  • Ensure appropriateness of MedDRA and WHO-DD coding performed by CRO drug safety staff with input from Medical Monitor
  • Coordinate the submissions of expedited and non-expedited safety reports to regulatory authorities, partner companies and other organizations as needed
  • Oversee the set-up of new safety projects, including development of study-specific Safety Management Plan and set-up of study specific safety systems and processes (as needed)
  • Manage the selection, performance, and auditing of DS and PV vendors, including case processing activities and quality assurance
  • Participate in the planning and preparation of the adverse event section of protocols for Rigel studies and review of CRFs (as necessary)
  • Support the Clinical Operation teams with respect to safety related issues as required
  • Participate in Clinical Team meetings and similar meetings representing Safety Department
  • Ensure that external investigators (e.g., ISTs, NCI) meet agreed upon safety reporting requirements to Rigel
  • Oversee preparation of the clinical sections of annual reports, and periodic safety reports
  • Oversee reconciliations of safety database, e.g. with clinical database for a given study and with post marketing product complaints
  • Provide expert guidance on regulations and their impact on Safety management processes and procedures
  • Lead the Safety Surveillance Committee with input from the Head of Clinical Sciences and Drug Safety, ensuring that agendas and materials and minutes are generated for quarterly meetings
  • Participate in the development and management of Data Monitoring Committees, including development of DMC charters (as needed) and ensuring that Drug Safety activities/listings for DMC meetings are completed in a timely manner
  • Develop, manage and implement departmental policies and SOPs

QUALIFICATIONS AND REQUIREMENTS:

  • Bachelor's degree in life sciences with 15 years' experience in biopharmaceutical industry in a global environment, of which 10 years are in Pharmacovigilance / Drug safety; or equivalent combination of advanced degree and experience
  • Bachelor's degree in Nursing or RN preferred; Master's Degree or PharmD preferred
  • Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both safety reporting and processing for clinical trial environments
  • Working knowledge of MedDRA dictionary with relevance to SAE analysis and SAE coding
  • Strong organizational, management, teamwork, interpersonal skills and professionalism required
  • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way
  • Outstanding communication skills (verbal and written)
  • Focus on detail with enthusiasm to constantly seek ways to improve processes and practices
  • Collaborate effectively with the study team, cross-functional team members, and external partners
  • Proficient with Windows: MS Office; and ability to learn new programs as needed
  • Proficient with common Safety databases (e.g., Aris, AERS, Argus, etc.) preferred

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.

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.

Keywords: Rigel Pharmaceuticals, Inc., South San Francisco , Drug Safety Senior Director, Other , South San Francisco, California

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