Pharmacovigilance Scientist

Job Description:

The PV Scientist assists and supports the medical and scientific functions within safety evaluations for assigned products. Such tasks include preparation and coordination of reviews of individual case safety reports as well as aggregate safety data. The PV scientist will also support Risk Management Plans by serving as a coordinator for the acquisition and preparation of data for review from multiple sources. Collect, and/or organize the data collected as part of Pharmacovigilance plan, RMP, product recalls and surveillance activities. Manage outsourced data collection, organization preparation with vendors as required. Support surveillance activities re vendors, consultants, and databases- assist with contracts, proposals and data sharing. Collation of draft reports, progress reports required for updating Health Agencies of RMP activities.
Support Physicians, such as case series review, data review, draft reports. Assist in organizing or running searches of safety or regulatory databases. Provide support to related PV activities such as preparation of reports for surveillance supports and collating reports for review of product quality data, support of health hazard evaluations, scientific presentations etc.
Participate in preparation, analysis and writing of ad-hoc and aggregate regulatory reports and, labeling support documents. The Pharmacovigilance Scientist has an advanced academic degree biological or natural science or health-care discipline (e.g. MS, MPH, etc).
Previous experience within the pharmaceutical industry and post-marketing safety data analysis preferred but not required. Familiarity with industry principles of drug safety, drug development, pharmacology, biostatistics, and pharmacoepidemiology. Basic knowledge of common data processing software. Excellent verbal and written communication skills. Ability to interpret, analyze and clearly present scientific and technical data in verbal and written format. Functional knowledge of EXCEL, PowerPoint, Microsoft Word. Team player, ability to work under tight timelines with poise. Ability to thrive in a global, matrix environment. Ability to manage high workload and critical issues
Candidates must have Drug Safety Aggregate Reports experience.
Responsibilities and skills include:
o Perform aggregate safety analysis and case level review
o Author, contribute, and coordinate the preparation of core safety deliverables (Aggregate Reports, Adhoc reports).
o Work closely with management to proactively support TA-related business
o Provide SMT support to enable proactive safety management
o Be responsible for product accountability by maintaining product intelligence (i.e., creating agendas and documenting decisions, milestones, action items in minutes)
o Deliver innovative solutions for aggregate safety strategy and analyses
o Excellent English verbal and written communication skills

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