Pharmacovigilance Scientist

Pharmacovigilance Scientist

A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Location: Cambridge MA, Duration: 1 year+ (possible Extension)

Job Responsibilities

• 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

KNOWLEDGE, SKILLS & ABILITIES:

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.

• 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.

Education:

Advanced Degree in biologic or natural science; or health case discipline

• 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.