Pharmacovigilance Scientist

Role Summary

The Pharmacovigilance Scientist (PVS) is a safety expert responsible for performing core pharmacovigilance activities on a product, in partnership with the Global Safety Officer, to identify safety signals, evaluate and analyze safety data for both marketed products and products in clinical development. The role involves safety surveillance across the product lifecycle and collaboration with safety and development teams. Location: Morristown, NJ; Cambridge, MA.

Responsibilities

• Manages proactive signal detection and safety management committee activities
• Coordinates and authors safety evaluations and responses to safety inquiries from internal or external stakeholders (i.e., Health Authorities) in collaboration with the safety team
• Drives end-to-end signal management process for assigned products in collaboration with the GSO and Pharmacoepidemiology
• Serves as a core member (coordinator) of the Safety Management Team, drives the agenda, produces the necessary data/outputs, prepares slide presentations, facilitates discussions and documents conclusions, and presents complete safety analysis
• Partners with the Safety Team to manage 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 development of Risk Management Plans
• Coordinates and oversees outsourced activities (i.e., signal detection reports, safety evaluation reports)

Education

• Bachelor of Science or Health Care Professional or preferred advanced health care discipline degree including Registered Nurse, Bachelor of Science in Nursing, Nurse Practitioner, Doctor of Pharmacy, PhD, Master of Health Science, Physician Assistant, Registered Pharmacist, Doctor of Medicine / Doctors of osteopathy, etc.

Qualifications

• 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)
• Strong knowledge of pharmacovigilance practices including US and EU pharmacovigilance regulatory requirements
• Evaluation, interpretation, and synthetization of scientific data
• Expertise in the collection of drug safety information from a variety of sources throughout the product life cycle to proactively detect, validate, and assess potential signals
• Team player that performs effectively in a cross-functional collaborative environment
• Self-motivated, able to prioritize, plan effectively and independently
• Strategic, business oriented, and problem-solving mindset while keeping patients and customers at the forefront
• Ability to present and critically discuss safety data in both internal and external discussion
• Project management skills with demonstrated attention to detail, keeping in mind the broader picture
• Working knowledge of common data processing software (i.e., Excel, PowerPoint, Word) and database systems
• English proficiency in communication skills with scientific subject matter

Skills

• Cross-functional collaboration
• Data analysis and interpretation
• Effective communication of safety data
• Safety data management and signal detection
• Regulatory knowledge (US/EU pharmacovigilance)