Senior Clinical Research Recruiter / Talent Acquisition - Beacon Hill Pharma
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
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Research, Analyst, and Consulting
Industries
Research Services and Biotechnology Research
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