The PV Scientist (PVS) will assist and support the medical and scientific functions within Risk Management Pharmacovigilance with safety evaluations for assigned investigational and/or marketed products. S/He will support Risk Management Plans by serving as a coordinator for the acquisition and preparation of data for review from multiple sources. The PVS will also support the Safety Physician, Risk Management Pharmacovigilance in monitoring the safety profile and evaluate the safety signals of assigned products, and participate in Safety Management Team (SMT) meeting and support related activities.
Coordinate, plan, and prepare aggregate reports including PBRER, DSUR, RMP and other safety related regulatory documents
Lead monthly signal detection and signal management activities (e.g., signal tracking)
Support PV related activities such as ad hoc review, health hazard evaluations, responses to regulatory inquiries, etc.
Attend SMT meetings and support SMT related activities
Support PV Physicians in the day-to-day support of assigned products
Assist in organizing or running searches of safety or regulatory databases
Assist and ensure corrective and preventative action plans are in place in response to audit or inspection findings
Liaise effectively with other PV staffs, PV partners and vendors on PV and risk management activities
Advanced academic degree in biological or natural science or health-care discipline (e.g. MS, MPH, PharmD. etc) with 2+ years of Drug Safety & Pharmacovigilance experience preferred.
Minimum of Bachelor's degree with 5 years or more of drug safety & Pharmacovigilance experience is required.
Oncology experience preferred
Hands-on experience in writing aggregate reports and risk management plan
Knowledge and experience of signal detection and data mining; signal detection using EudraVigilance is a plus
Ability to interpret, analyze and clearly present scientific and technical data in verbal and written format
Knowledge of MedDRA terminology and its application
Excellent verbal and written communication skills; communicate changes and progress
Functional knowledge of EXCEL, PowerPoint, Microsoft Word
Manage competing demands and change approach or method to best fit the situation
Ability to identify and resolve problems in a timely manner
Contribute to building a positive team spirit and share expertise with others
Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.