Remote - Pharmacovigilance (PV) Scientist

A highly reputable biopharmaceutical corporation is currently hiring a qualified Pharmacovigilance (PV) Scientist to work remotely in the United States.

Job Description:

• Contribute as a member of the Drug Safety team to scenario planning, strategy analysis, portfolio prioritization, budget management and forecasting.
• Document Management and Authoring for aggregate safety reports (eg.PSUR, DSUR, Line listings) in close collaboration with the safety product lead and operational functions.
• Safety Risk Management Team slide preparation
• Works closely with the safety physician to analyze potential safety issues, including signal detection, signal evaluation and signal management.
• Collaborates proactively with study teams, cross-functional team members, external business partners and vendors to apply knowledge and analytical skills to problems in specific therapeutic areas.
• Contribute to signaling and data mining activities utilizing internal and external sources of data.
• Performs signaling data review from all sources including but not limited to: Empirica, Clinical and Safety outputs, Literature, and HA requests
• Assist in the evaluation of potential safety issues and quality risk assessment reports.

Education:

• Degree in a medical or healthcare related discipline ( MSN RN, PharmD, Physician Assistant) is required

Experience:

• A minimum of 5+ years in the pharmaceutical industry with experience in drug safety/pharmacovigilance.
• Document Management and use of VEEVA preferred.
• Specific experience in RNA therapeutic area at a global level is an advantage.

Strong skills and experience in:

• Supporting the development and application of business process improvement methodologies and/or developing ideas into practical business solutions.
• Ability to manage teams and to work in a matrix environment in accordance with the company leadership commitments and values. Preferably with experience of working across diverse geographic areas, business settings and cultures.
• Pharmacovigilance, safety or clinical science, and/or other relevant areas of clinical biopharmaceutical development or medical affairs.
• Knowledge of Argus Safety Databases
• Knowledge of Signaling tools (eg. Empirica)
• Advanced knowledge of Global (including US, EU, LATAM, APAC) Pharmacovigilance regulatory requirements
• Strong planning, organizational, written and verbal communication skills