Pharmacovigilance Scientist

Streffco Consultants, Inc., is an international technical staffing and systems integration organization. We provide technology and business operations resources on a project, contract, contract-to-hire or direct hire basis.

PV Scientist as a Subject Matter Expert supports Pharmacovigilance activities within SABR medical function. PV Scientists is responsible for overseeing and leading the process of safety signal management process, authoring / contributing to aggregate safety reports (PSURs, DSURs, etc.), responding to safety questions from internal and external stakeholders, reviewing medical and scientific literature for safety information, and conducting/overseeing Clinical Trial PV medical activities.

* Evaluate safety data and signals as part of ongoing pharmacovigilance activities, including synthesis of data from multiple sources and authoring signal evaluation reports. * Manage literature review for safety information. * Author responses to safety questions from regulatory authorities. * Author and/or contribute to aggregate safety reports, as needed. * Interpersonal skills * Demonstrated leadership and team building skills as well as the ability to perform effectively in a dynamic matrix environment.

* Minimum 7 years Pharmacovigilance experience and strong drug development foundation, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations, as well as knowledge of case processing, expedited reporting rules, and safety database concepts. * Minimum 5 years PV experience, including experience in aggregate safety reports and Safety signal management. * Demonstrated strategic and critical thinking, ability to apply clinical judgment to interpret case information. * Ability to understand, interpret, analyze, and clearly present scientific and medical data in verbal and written format including intermediate understanding and application of medical concepts and terminology. * Strong organizational skills, including the ability to prioritize independently with minimal supervision. **Educational Requirements:** * Advanced Degree in biologic or natural science; or health case discipline