Drug Safety Scientist

Immediate need for a talented Drug Safety Scientist. This is a 12+ months contract opportunity with long-term potential and is located in Chicago, IL (Remote). Please review the job description below and contact me ASAP if you are interested.

Job ID: 25-73230

Pay Range: $45 - $50/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• Author aggregate safety reports required by health authorities such as, Development Safety Update Reports (DSUR), Periodic Benefit-Risk Evaluation Reports (PBRER), US Periodic Adverse Drug Experience Report (PADER).
• Produce high quality, accurate and fit-for-purpose evaluation documents with clear conclusion, in response to internal or regulatory authority safety-related requests.
• Run accurate queries and provide standard outputs of the data from the safety database; create draft reports/data tables and to perform searches of the safety database for ad-hoc queries.
• Support preparation of RMP and post-marketing safety monitoring activities.
• Review publications from worldwide medical/scientific literature to identify signals and applicable information for inclusion in aggregate safety reports.
• Conduct routine and ad-hoc signal detection and evaluate safety data and signals as part of ongoing pharmacovigilance activities. This includes the ability to summarize data from multiple sources and authoring signal evaluation reports.
• Provide support to the compilation of information for reference safety information (including Company Core Safety Information).
• Participate and contribute to Safety Management Team meetings.
• Support Drug safety physicians in handling issues related to both clinical and post-marketing safety, as needed.
• Perform other duties related to the position as necessary and as defined in SOPs and/or at the request of supervisor.

Key Requirements and Technology Experience:

• Key skills; Should have Bachelors/master s degree in science (Pharmacy, Biotechnology or Chemistry).
• Experience in pharmacovigilance is a must (5+ years).
• Clinical Trial and Post-Marketing experience.
• Minimum of 3 years of pharmaceutical/biotechnology PV experience, including clinical trial and post-marketing experience
• Bachelor or Master of Science(required)
• Experience in authoring of aggregate safety reports.
• Strong knowledge in FDA, EU, ICH guidelines, initiatives and regulations governing pharmacovigilance. Experience with coding according to the Medical Dictionary for Regulatory Activities (MedDRA).
• Ability to function in an environment of rapidly changing priorities and to manage multiple projects simultaneously while maintaining a high level of quality, accuracy and attention to detail.
• Excellent oral and written communication skills.
• Excellent computer skills, including Microsoft Word, PowerPoint and Excel.

Our client is a leading Electrical Logistics Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

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