Executive Director - Pharmacovigilance and Drug Safety - Lexicon Pharmaceuticals - New York

Job description
We are currently recruiting for an Executive Director, Pharmacovigilance and Drug Safety in Princeton, New Jersey or The Woodlands, Texas.
The Executive Director has full responsibility for the safety and pharmacovigilance risk management activities of investigational compounds and in the future marketed products. The successful incumbent will proactively help shape the safety strategic direction for investigational and marketed products by bringing medical and safety expertise to the company. This includes delivery of the medical evaluation of single cases; signal detection and evaluation activities; all periodic safety reports, risk management plans and regulatory documents; ensuring definition, implementation and evaluation of risk mitigation actions, and safety input to clinical trial activities as appropriate.
All activities will be performed in close collaboration with Clinical Operations and Regulatory Affairs and using best quality and pharmacovigilance practices.

Responsibilities include, but are not limited to:
Develops and coordinates safety surveillance procedures for Lexicon products, to ensure corporate compliance with national and international adverse event reporting requirements.
Assures compliance with applicable regulations and standard operating procedures for the reporting of adverse events to regulatory agencies.
Coordinates the development of guidelines and insures the uniform and timely processing of adverse event reports.
Provides safety surveillance for all clinical trial products for development of product safety profiles and informed consents, investigator brochures, protocols and clinical study reports.
Interfaces with internal and external collaborators to develop programs and processes to meet regulatory reporting requirements.
Oversees the development and preparation of reports for company management as well as external regulatory agencies.
Oversees the preparation of NDA Safety Updates, IND (Investigational New Drug) safety reports, investigator communications, Product Labeling/Package Inserts, Risk Management Plans and other reports as necessary.
Participates as the drug safety resource on internal teams.
Leads and develops a small drug safety/pharmacovigilance team.

Desired Skills and Experience
Required: US MD/DO degree
Preferred: Active or inactive US license to practice medicine, or international equivalent
Strongly Preferred: At least 1-2 years of clinical experience, beyond residency
Profound experience (~5+ years) in Drug Safety and Pharmacovigilance, including safety in clinical development and post-marketing safety
Leadership skills with proven ability to lead cross functional teams
Ability to communicate with individuals at all levels (administrative to key thought leaders)
Excellent oral and written communication skills
Excellent interpersonal, negotiating and team building skills
Ability to effectively lead, develop, mentor and manage others
Ability to work independently, analyze and work with attention to detail, process and prioritize complex information, and problem solve
Ability to exercise creativity and judgment
Expert knowledge of the regulations governing pharmacovigilance
Working knowledge of industry standard pharmacovigilance databases

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