Associate Director, Drug Safety - South San Francisco, CA | Biospace
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Associate Director, Drug Safety

Rigel Pharmaceuticals, Inc.

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Location:
South San Francisco, CA
Posted Date:
5/18/2017
Position Type:
Full time
Job Code:
R17-006-08-04
Salary:
DOE
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Drug Safety, Pharmacovigilance, QC, Quality Control,

Job Description

ABOUT RIGEL:
Rigel is a clinical-stage biotechnology company dedicated to the discovery and development of novel, targeted drugs in the therapeutic areas of immunology, oncology and immuno-oncology.  Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms.

Our business strategy is to transition to a commercial-stage company with our Phase 3 results from fostamatinib in immune thrombocytopenic purpura (ITP).  We continue to build an extensive portfolio of products in immunology and oncology, monetizing select assets through attractive partnerships.  This year, Rigel plans to submit an NDA for Fostamatinib.  The Head of Clinical Science & Drug Safety will work closely with the CMO and the head of regulatory to ensure optimal review of the NDA, including active participation in an advisory committee meeting preparation, with another drug candidate in development in Q1 2018.


POSITION SUMMARY:
The Associate Director, Drug Safety is accountable for the day-to-day functioning and performance of safety activities of the Pharmacovigilance  (PV) and Drug Safety (DS) department at Rigel.  This position is integral for the safety assessment of the drug safety processes in conjunction with company overall objectives.  The Associate Director of Drug Safety 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 Head of Clinical Science and Drug Safety in managing the safety assessment of products, including review of individual and aggregate AEs and the scientific literature, 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:  
•   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.
•   Perform Quality Control review of all cases to ensure accuracy, integrity and completeness of information entered in the CRO 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 vendor safety reporting activities (both DS and PV) including 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 reconciliation of safety database with clinical database for a given study.
•   Provide expert guidance on regulations and their impact on Safety management processes and procedures.
•   Manage the Safety Review Committee with input from CMO, 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 activities/listings for DMC meetings are completed in a timely manner and meeting outcomes are documented as needed for requests from IRBs/ECs and/or regulatory authorities.
•   Develop, manage and implement departmental policies and SOPs.
•   Performs other duties in Clinical Operations as requested by VP, Development Operations.

Requirements

QUALIFICATIONS AND REQUIREMENTS:  
•   Bachelor’s level degree in life sciences, nursing or RN. Master’s Degree or PharmD preferred
•   Previous Pharmacovigilance / Drug safety experience of at least 7 years in the biopharmaceutical industry in a global environment is a plus
•   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.
•   Ability to manage multiple projects in a fast-paced environment.
•   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.  
•   Familiarity with common Safety databases (e.g., Aris, AERS, Argus, etc.) preferred.