Associate Director, Drug Safety

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

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