Pharmacovigilance Director

Biotech Company: Pharmacovigilance Director

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Location:                    New York, local candidates only
Reports To:                 CMO
Compensation:           $175K base, + bonus and benefits
 
Are you ready to join a cutting edge, growing, global biotech that is making a difference in the biotechnology field?  We are seeking a high energy, dynamic leader who can hit the ground running and is ready for this exciting opportunity.  For immediate and confidential consideration, please send a Word version of your resume and note where you heard of this opportunity. 
 
TOP CANDIDATE WILL HAVE STRONG STATISTICS EXPERIENCE, AS WELL AS 3 YEARS OF CLINICAL EXPERIENCE POSTDOC WITHIN A BIOTECH OR PHARMA COMPANY.

Requirements for the role

• Medical Degree highly preferred; advanced degree required. 
• Additional training in epidemiology or statistics desired.
• At least 3 years in drug development, including 2 years in drug safety at an operational or medical position.
• Proven ability to analyze, interpret, discuss and represent safety information, both in writing and orally.
• Experience in preparing or contributing to preparation of clinical safety assessments and regulatory reports / submissions involving safety information.
• Experience with (safety or others) issue management.
• Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications.
• Excellent computer skills; knowledge of ARISg safety system a plus.
• Knowledge of domestic and international safety regulations, Good Clinical Practices, principles of drug development and safety assessment of marketed and investigational drugs.
• Excellent verbal and written communication skills, including formal presentation skills are required.
• Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way.

Job Responsibilities Include:

• Monitoring clinical safety of projects / products and responds appropriately.
• Performing medical assessment and related activities for single cases, including collecting additional follow-up information as necessary, medical evaluation of quality defects, review of line listings of single cases, and preparation of investigator notifications.
• Identifying safety signals based on the review of solicited or unsolicited single cases and confirm that they are not overlooked.
•  Performing signal detection, monitoring and evaluation based on single cases, aggregate data and signal detection tools.
•  Providing input into responses to inquiries from regulatory authorities or health care professionals on safety issues.
• Preparing safety data for health authority review boards.
• Providing input to responses for legal queries and CPO requests involving safety issues.
• Providing pharmacovigilance input to initial development of basic prescribing information and is responsible for pharmacovigilance input into updates of this information.
• Preparing medical input to aggregate clinical safety regulatory reports.
• Providing input to safety profiling and risk management plan.
• Providing guidance as appropriate to Clinical Safety Operations for the coding and expectedness assessment of adverse event reports.
• Providing expert evaluation on the clinical context of adverse event reports, assessment on the medical conditions, and the implications on Company drugs.
• Collaborating productively with colleagues from Clinical Research, Drug Regulatory Affairs, Medical Affairs and Information, Statistics, Safety Data Management, Epidemiology and other related departments.
• Participating in review of clinical study protocols / reports / other regulatory documents as needed.
• Providing support as needed for licensing activities, regulatory authority inspections and for project recall activities.