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Senior PV Scientist :

Artech Information Systems
Cambridge, Massachusetts, United States
January 18, 2019


Job Description:

Job Title: Senior PV Scientist

Location: Cambridge, MA

Duration: 6 Months


Senior. PV Scientist serves as a product lead for Pharmacovigilance activities within the SABR Medical function.

The Senior PV Scientist team is responsible for overseeing and leading the process for safety signal management activities, aggregate reports responding to safety questions from internal and external stakeholders, reviewing medical and scientific literature for safety information, and supporting Clinical Trial PV medical activities.

The Senior PV Scientist also serves as a Subject Matter Expert for SABR and cross-functional teams on relevant global safety regulations and guidelines; data output and analyses; and product specific information.

Principal Accountabilities Note: It may be helpful to review a normal ‘day in the week/week in the month’ to accurately estimate time spent on these key activities

Accountability Descriptions

Leads the signal management process (i.e., signal tracking, leading review meetings, etc.) for assigned product(s) and evaluates safety data and signals as part of ongoing pharmacovigilance activities.

Includes synthesis of data from multiple sources and authoring signal evaluation reports.

Leads signaling review process and product Safety Signaling Team meetings.

Manages literature review for safety information.

Global Safety Officer SABR MDs Epidemiology 30% Collaborates with Global Safety Officers and other SABR MDs for assigned investigational programs including clinical trial activities (protocol review, ICF review, etc.) safety committee management, data analysis, signal detection, ad hoc requests and other product activities, as assigned. Global Safety Officer SABR MDs Clinical Development Global Clinical Operations Regulatory 30% Leads process for responding to safety questions from regulatory authorities.

Global Safety Officer SABR MDs Regulatory Epidemiology Biostats 20% Contributes to and leads initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management and responding to ad hoc safety questions.

Associate Director / Director PV SABR Compliance 10% Leads and collaborates with Aggregate Reports on strategy, review and finalization of aggregate safety reports for assigned products, such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and Risk Management Plans (RMPs).

Sr PV Scientist / PV Scientist (Aggregate Reports) Global Safety Officer SABR MDs SABR Compliance 10%

Minimum Education Requirements Minimum educational level necessary to perform the job (High School diploma, Associate’s Degree, Bachelor’s Degree, Masters, PhD) Bachelor’s Degree in biologic or natural science; or health case discipline Advanced degree (PhD, MPH, NP, PharmD, etc.) preferred

Minimum Experience Requirements Minimum 7 years Pharmacovigilance experience, including experience in aggregate safety reports and safety signal management. Strong background in clinical trial drug safety is required

• Understands, interprets, analyzes, and clearly presents scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology