Job Opening
Date: June 19, 2008
Title: Senior Director, Drug Safety
Reports to: Chief Medical Officer
Department: Medical
Summary of Job:
Develops approaches for proactively assessing safety databases and detecting potential safety signals. Provides input, supervises and executes medical safety strategy for compounds in development or commercialization. Applies medical expertise and provides guidance to develop strategy and execute pharmacovigilance activities, including critical evaluation and follow up of potential safety signals, evaluation, processing and reporting of cases. Responsible for medical supervision of staff who performs assessment or serve as primary reviewer for adverse event reports, generation/review of aggregate reports, signal evaluation, pharmacovigilance, risk management, and risk communication for assigned development and commercial products.
Essential Duties and Responsibilities:
- Has primary responsibility for evaluation of safety data and concerns arising in clinical development and from any marketed products.
- Develops strategies to proactively locate potential safety concerns with investigational or marketed compounds, develops risk management strategies around potential drug safety issues.
- Provides safety input to clinical team and safety training to internal and external audiences.
- Evaluates or reviews single case reports, adverse events of special interest narratives and practices for collecting safety data.
- Represents the Drug Safety function at meetings with regulatory authorities and third parties such as licensing or co-development partners, consultants, opinion leaders. Collaborates with internal and external business partners to ensure adequate safety monitoring practice implementation during clinical trial conduct.
- Researches best practices in the industry involving drug safety and evaluates and oversees their implementation in the organization.
- Provides medical input in regulatory documents: INDs, NDAs, PSURs; Annual Safety Reports, Core Data Sheets, Investigator's Brochures, Clinical Study Reports, Clinical Summaries and Clinical Overviews (benefit-risk evaluation).
- Leads the development of Risk Management Plans, query responses (including Health authorities, internal requests, health care providers) and responses to safety related inquiries from regulatory authorities and internal and external partners.
- Provide strategic guidance to clinical and senior management teams in the area of product safety.
- Develop strategies to proactively locate potential safety concerns and develop risk management strategies.
- Responsible for assuring compliance with applicable regulations and standard operating procedures related to drug safety.
Job Requirements:
- Education: MD, PhD or Pharm.D degree
- Experience: At least 3 years’ experience in Pharmaceutical Industry Drug Safety Function, at least 5 years’ overall industry experience.
Other Required Skills and Abilities:
- An understanding of standard industry practices pertaining to drug safety and pharmacovigilance, particularly in relation to signal detection and evaluation. Knowledge of US and EU drug safety and pharmacovigilance monitoring requirements.
- Demonstrated knowledge of and ability to interpret and apply local drug safety regulations.
- Demonstrated competence in obtaining, analyzing, disseminating, and reporting safety information in compliance with regulations
- Experience in data analysis and medical evaluation of safety data
- Hands on experience on regulatory submissions involving safety data
- Proficiency with standard desktop and pharmacovigilance computing programs including signal detection and data mining software, and databases (FDA, AERS, GPPRD)
- Excellent written and verbal communication skills
- Team player with ability to function in a multi-disciplinary environment
- Self-motivated, able to prioritize and plan effectively
- Attention to detail
- Expertise in internal medicine, endocrine or obesity therapeutics within the pharmaceutical industry.