Penfield Search Partners
Contact: Neisha Camacho/Terra Parsons – email@example.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.