Pharmacovigilance Scientist

Artech Information System LLC; Bridgewater (MA); On-site; USD 75,000 - 100,000; Full time

Job summary

A leading IT staffing company is seeking a Pharmacovigilance Scientist to join their safety team. The role involves proactive pharmacovigilance activities, safety evaluations, and regulatory responses. Candidates should possess a Bachelor's degree in a scientific or healthcare field and have strong written and verbal communication skills. Experience in pharmacovigilance practices and knowledge of US and EU regulatory requirements is highly valued. This is an opportunity to contribute significantly to safety management within a dynamic team.

Qualifications

• Minimum Bachelor's degree in Science or Health Care fields.
• Advanced degrees (MD, PharmD, PhD, or equivalent) are preferred.
• Basic knowledge of common data processing software required.

Responsibilities

• Perform proactive pharmacovigilance activities on assigned products.
• Conduct signal detection and safety management committee activities.
• Author safety evaluations and assist with regulatory responses.
• Coordinate outsourced pharmacovigilance activities.

Skills

Knowledge of pharmacovigilance practices

Knowledge of US and EU pharmacovigilance regulatory requirements

Excellent written and verbal communication skills

Ability to evaluate and synthesize scientific data

Team player

Self-motivated and independent

Fluent in English

Good organizational skills

Education

Bachelor of Science or Health Care Professional degree

Advanced health care discipline degree

Tools

Excel

PowerPoint

Word

Job description

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

Job Description

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).

• 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

Education and Experience

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.

Required Experience:

• Basic knowledge of common data processing software (i.e., Excel, PowerPoint, Word) and database systems