Pharmacovigilance Scientist

Contact: Allie Spink – aspink@penfieldsearch.com

THE POSITION: Reporting to the Pharmacovigilance Operational Leader, the Pharmacovigilance Scientist Lead will be responsible for providing strategic and scientific support to Clinical Development to ensure the successful operational execution of clinical trials within assigned portfolios at the company. The successful candidate will be an experienced hands-on leader that will serve as a functional lead and a subject matter pharmacovigilance expert.

The Pharmacovigilance Scientist Lead will be responsible to ensure safety oversight for clinical studies in all phases is conducted in accordance with the protocol, in compliance with ethical and regulatory requirements, within timelines and budget and in accordance with company SOPs, GCP, and ICH guidelines.

In addition, the Pharmacovigilance Scientist Lead will work collaboratively with other leaders within the organization to improve the effectiveness and efficiency of processes and procedures supporting clinical trials.

SUMMARY OF RESPONSIBILITIES

• Provide strategic and scientific pharmacovigilance oversight of Therapeutic (or Vaccine) clinical development portfolio.
• Lead signal management processes for assigned studies in collaboration with the PV physician, CDL and vendors
• Support clinical studies, providing medical and quality review of individual serious adverse events, adverse events of special interest, pregnancy reports to ensure accuracy, integrity, and completeness.
• Contribute to study protocols, investigator brochures, safety management and expedited reporting plans, clinical study reports with associated tables, listings and figures, and other study related documents from a clinical safety perspective.
• Collaborate with cross functional team on regulatory submission of safety documents such as DSURs and other required aggregate study reports to support regulatory compliance in the study regions.
• Support Safety review governance and benefit-risk management by contributing to scheduled and ad hoc meetings for clinical safety data for the study with team or committee members.
• Author and review Standard Operating Procedures as required for support of Pharmacovigilance processes and clinical study management.
• Provide writing support for abstracts, articles, posters, or papers.

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 of 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 values with a commitment to deliver results against our mission.
• Local and international Travel ~20%