Job Description

Our client is a transformative, clinical-stage biopharmaceutical company dedicated to developing innovative therapeutic options for the treatment of cardiovascular metabolic diseases.

Our client seeks someone who can provide strategic and operational leadership for all clinical safety and post-market pharmacovigilance activities to ensure the safety of products throughout their lifecycle, in compliance with global regulatory requirements and organizational objectives.

Key Responsibilities

• Lead the Drug Safety function/team and provide guidance and support to team members
• Provide the strategic Safety leadership both within the Drug Safety team and cross-functionally with other stakeholders (e.g. Clinical, Regulatory, Medical Affairs, etc)
• Oversee the collection, analysis, and reporting of adverse events and safety data
• Ensure timely submission of safety reports to regulatory authorities for individual events and aggregate reports.
• Collaborate with cross-functional teams to ensure the safety of products throughout their lifecycle.
• Stay up-to-date with the latest pharmacovigilance regulations and guidelines.
• Work with Contract Research Organizations (CROs) to ensure safety reporting, tracking, report generation and writing are consistent with our needs for compliance with internal and external SOPs and global HA requirements
• Drives production and submission of periodic regulatory documents (DSURs, PSRs) according to agreed process and timelines
• Chairs our clients safety management team and supports the Chair and Executive Safety Committee in achieving their objectives.
• Reviews and provides technical approval for investigator brochures, protocols, Informed consents, final study reports and external data monitoring committee charters
• Leads or supports the safety component of global regulatory submissions for new products, formulations or indications, with liaison with other functional experts
• Leads or supports the development of standard operating procedures (SOPs) and processes related to Drug Safety

Key Requirements

• At least 15 years of experience in PV and drug safety, with at least 5 years in a leadership role
• Strong knowledge of global clinical trial and PV regulations and guidelines.
• Understanding of all components of PV throughout a products lifecycle, both strategic and operational.
• Thorough knowledge of the clinical development process and Good Clinical Practices required, previous experience within a clinical development function preferred.
• Ability to work collaboratively in a cross-functional team environment.
• Experience in managing a team of high performing professionals.
• Demonstrated ability to prioritize multiple tasks and deliver to deadlines with a high standard of quality.
• Expert evaluation skills and analytical thinking.
• Excellent communication and interpersonal skills.

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