Director, Drug Safety & Pharmacovigilance
Impax Laboratories - Hayward, CA

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Primary Responsibilities:
Provides oversight for safety monitoring (Drug Safety, Risk Management and Pharmacovigilance) for Generics, Brand, Post-Marketing and licensing partners, as applicable

Participates with Senior Management to establish strategic safety plans and objectives for the company

Maintains current knowledge of safety related regulations in all markets and ensures compliance with global regulatory requirements (regulations and guidelines) for safety reporting/risk management

Anticipates regulatory implications of emerging safety issues and develops strategies for handling/managing such issues

Participates, as needed, in interactions with and presentations to global regulatory authorities for safety and risk management

Provides oversight of safety vendor(s) for all outsourced safety functions

Ensures the development of Risk Management Plans, Safety Management Plans and Signal Detection activities for all applicable products

Provides/oversees safety related activities with respect to IND, NDA and safety updates for submission to regulatory authorities

Mentors, trains, develops and supervises direct reports

Ensures appropriate Standard Operating Procedures and guidelines are in place for comprehensive safety monitoring and reporting

Leads Pharmacovigilance audits

Qualifications:
MD, PhD, PharmD,or equivalent in a scientific discipline

Minimum of 10 years relevant experience in a pharmaceutical/biotech industry

Knowledge of global safety regulations as well as knowledge of the documents and data bases required to support risks management and pharmacovigilance activities

Excellent leadership skills/ability to interact effectively with sponsor and regulatory authorities on safety related issues

Experience managing and developing staff

Excellent written, and oral communication skills

IMPAX Laboratories - 23 months ago - save job
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