POSITION SUMMARY:

The Associate Director will support the Rigel Drug Safety Pharmacovigilance Department (the department) in the development of medicinal products for use in clinical research and in the commercial setting.

Salary Range: National $160,000 - $190,000 / Premium $175,000 - $205,000

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Assist with processing individual case safety data in accordance with established practices
Assist with the evaluation of drug safety data to identify safety signals and evaluate such signals for evidence of causal association with a drug product
Assist to prepare summary drug safety evaluations such as IND Annual Reports, PADER, DSUR & PSUR reports, safety sections of clinical study reports, integrated summary of safety
Support department operations, procedural strategies, training programs, service provider oversight and management, and procedural audits.
Support the department in establishing policies, business strategies, and procedural compliance with corporate and regulatory requirements and other contractual obligations.
Act as liaison with therapeutic leads, safety physicians, and biostatisticians, and other important stakeholders on designed projects
Collaborate with department staff to author and update pharmacovigilance (PV) standard operating procedures and processes
Support activities related to quality assurance, including authoring and editing deviation reports as well as authoring, editing and implementing corrective and preventative action measures
Provide/review and confirming the reported event(s) seriousness, expectedness (using the applicable reference safety information), relatedness
Provide/review determination of ICSR reportability for expedited or periodic submission
Provide/review medical assessments of individual case safety reports (ICSRs)
Provide/review ICSR narratives for accuracy and completeness based on source data
Provide/review MedDRA coding
Provide/review medically relevant queries
Provide/review a company medical comment
Provide/review the Analysis of Similar Events for ICSRs requiring expedited submission
Provide/review safety sections of clinical study protocols
Develop/review drug safety documents, such as Safety Plans for client clinical studies and Clinical Study Reporting Forms
Maintain regulatory and department compliance by ensuring timely completion and submission of ICSRs to regulatory agencies, study investigators, licensing partners, and CROs
Represent the Drug Safety Department in client cross-functional clinical team meeting
Maintain a high level of understanding of federal and international regulations to guide departmental policies and procedures
Successfully complete assigned projects
Draw on knowledge of Drug Safety, disease specific clinical knowledge and understanding of business objectives to solve complex problems in creative and effective ways, as well as to anticipate routine problems and mitigate them without supervisory intervention

KNOWLEDGE AND SKILL REQUIREMENTS:

Demonstrated ability to organize assigned projects for efficient task processing
Demonstrated ability to work across teams and departments to meet project goals
Demonstrated ability to accurately and efficiently analyze data in the context of an understanding of medical and pharmacological concepts Typically requires a RN, PA, RPh, or equivalent plus of 3 to 5 years of PV experience
Deep knowledge of domestic and international PV regulations, industry practices and standards
Highly organized
Strong motivation to succeed and successfully complete assigned projects
Strong problem-solving skills
Strong attention to detail
Excellent in functioning as a team member and team leader
Resourcefulness and personal organization skills
Excellent working knowledge of MedDRA and WHODRUG coding dictionaries.
Solid technical writing skills
Excellent skills with Microsoft Word, Excel, PowerPoint
Excellent experience in using a safety database, including Argus
Knowledge of MedDRA and WHO DRUG coding dictionaries
Experience with pharmacovigilance audit processes
Positive Attitude and Energy – Exhibits an upbeat attitude, a genuine interest in others and a sense of humor. Energizes others and heightens morale through her/his attitude
Excellent written and oral communication skills
Develops and articulates ideas and information that generate understanding and creates a climate that motivates and encourages others to participate.

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.

Rigel Pharmaceuticals, Inc.

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Associate Director, Drug Safety