Vice President, Clinical Safety and Pharmacovigilance

Contact: Kevin Mednick
Phone: (215) 658-1379

Position Overview

Our client is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health.

The position will be responsible for safety and pharmacovigilance services throughout the company.

Key Responsibilities

• The Vice President, Clinical Safety and Pharmacovigilance is a leadership role, sitting on theR&D leadership team, and responsible for development and maintenance of a high quality,compliant, efficient and value-adding safety function.
• The role is responsible for ensuring global Pharmacovigilance and risk management activities are consistent with internal policies and compliant with global regulations and quality standards for the company’s clinical development programs.
• As chair of the Safety and Risk Management Committee, this position oversees medical safety,risks and their appropriate and timely representation.
• This role provides strategic guidance regarding patient safety and compliance-related mattersin order to feed these aspects into the overall broader company portfolio and developmentstrategy.
• This role represents the benefit/risk assessment for the sponsors programs to external parties and contributes to the review and compilation of key external regulatory facing documents.
• This role develops, maintains internal governance processes, cross-functional activities related to safety and manages external contractual relationships (e.g. CRO’s) covering PV and medical risk management activities on the sponsors behalf

Key Requirements

• Medical Doctor with specific experience in pharmacovigilance, safety risk management in psychiatry drug development (consideration of broader neuroscience background).
• Significant experience in broader pharmacovigilance / safety risk management within the pharmaceutical /biotech environment (industry, CRO), with a number of those being in key leadership positions of responsibility.
• Broad experience of representing and articulating benefit risk assessments to Regulatory Agencies on behalf of sponsor companies
• Proven track record in leading and developing teams, global functions and working cross-functionally.
• Familiarity with relevant drug safety, quality and governance related systems and their timelyand complaint usage.
• Proven track record in innovative approaches to continuous improvement and changemanagement in clinical safety and pharmacovigilance systems, processes and standards.
• Excellent communication, collaboration and influencing skills.
• Proven effective leadership cross functionally and across organizations.

Location(s)

If interested, please send a MS Word version of your resume to [email protected]

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