Pharmacovigilance Scientist

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Job description

Job Summary:

The Pharmacovigilance Scientist (PVS) will serve as a core member of the safety team and is responsible for performing proactive pharmacovigilance activities on a product, or group of products in a therapeutic area or franchise, in partnership with the Global Safety Officer (GSO) to evaluate safety data and signals for both marketed products and products in clinical development. This includes performing signal detection and safety management committee activities, authoring safety evaluations, contributing and reviewing of aggregate safety reports, assisting with ad hoc regulatory responses, facilitating signal management process for assigned products (i.e., signal tracking, data analysis, leading review meetings, presenting, etc.) in collaboration with the GSO and Pharmacoepidemiology.

Additionally, the PVS will support the GSO with other safety related activities associated with new drug applications / regulatory filings, benefit risk assessment and safety risk management and support activities related to risk minimization including dRMP/RMP and REMS. The PVS will provide coordination and oversight to outsourced activities (i.e., signal detection reports, clinical overviews).

Requirements:

Education:

* Minimum Bachelors of Science or Health Care Professional (RN, BSN, Nurse Practitioner or Physician Assistant, RPh); or preferred advanced health care discipline degree (MDPharmD, PhD, Masters of Science, etc.) or equivalent qualification.

Experience:

* Preferred 2 years with relevant experience (including industry experience) with a working knowledge of drug safety and risk management, and understanding of drug development, basic knowledge of regulatory guidelines and medical coding (i.e. MedDRA).
* Basic knowledge of common data processing software (i.e., Excel, PowerPoint, Word) and database systems
* Good knowledge of pharmacovigilance practices
* Good knowledge of US and EU pharmacovigilance regulatory requirements
* Excellent written and verbal communication skills
* Ability to present and critically discuss safety data in both internal and external discussions
* Ability to evaluate, interpret and synthesize scientific data (analytical thinking)
* Team player with ability to function in a cross-functional environment
* Self-motivated, able to prioritize and plan effectively, and independently, with minimal supervision
* Fluent in English (verbal and written)
* Good moderator skills
* Ability to navigate in databases and pull information correctly
* Good organizational skills and attention to detail
* Good knowledge of pharmacovigilance practices
* Good knowledge of US and EU pharmacovigilance regulatory requirements
* Excellent written and verbal communication skills
* Ability to present and critically discuss safety data in both internal and external discussions
* Ability to evaluate, interpret and synthesize scientific data (analytical thinking)
* Team player with ability to function in a cross-functional environment
* Self-motivated, able to prioritize and plan effectively, and independently, with minimal supervision
* Fluent in English (verbal and written)
* Good moderator skills
* Ability to navigate in databases and pull information correctly
* Good organizational skills and attention to detail