Contact: Neisha Camacho/Terra Parsons – teamnt@penfieldsearch.com
Summary of Responsibilities:

• Provide strategic pharmacovigilance oversight of key performance indicators, pharmacovigilance regulatory reporting timelines
• Participate in audits and inspections as the Clinical Safety and Pharmacovigilance Subject Matter Expert.
• Oversee compliance and management of safety vendors supporting clinical studies, monitoring the quality and compliance of vendor deliverables
• Support Pharmacovigilance Functional Service Provider Governance, working closely with Strategic Sourcing for new programs as business needs and capacity evolve.
• Monitor compliance of regulatory submission documents, DSUR, 6 monthly SAHPRA reports and other required aggregate study reports to support regulatory compliance in the study regions.
• Negotiate and review Safety Data Exchange Agreements
• Collaborate with vendor and global partnerships (academic, nonprofit, large pharma and biotech companies), ensuring compliance with safety data exchange agreements for safety and regulatory reporting across programs
• Author and review Standard Operating Procedures as required for support of Pharmacovigilance Processes and clinical study management.

Qualifications: The successful candidate will be an innovative and collaborative individual who thrives in a “get it done” type of environment with diverse clinical operations experience and the following mix of personal and professional characteristics:

• Minimum B.A./B.S. degree in science/healthcare field, pharmacy or a nursing. Advanced degree preferred
• 10+ years’ experience in Drug Safety & Pharmacovigilance experience at biotechnology or pharmaceutical company or CRO
• Must have proven experience in CRO oversight, vendor selection & contract negotiation
• Pre-clinical to Ph III experience with a particular focus on Phase III (large scale global clinical trials)
• Global experience working with developing countries and target populations – Africa, South East Asia, a plus
• Experience working with Infectious Diseases or Vaccines experience a plus
• Detailed knowledge of GCP, ICH Guidelines and current US FDA regulations
• Experience working in highly matrixed organization
• Clear and effective communication & diplomacy skills
• Excellent leadership and interpersonal skills; ability to collaborate across disciplines
• Attention to detail and ability to multitask
• Demonstrated passion for the company’s values with a commitment to deliver results against our mission.