Drug Safety Scientist

Pyramid Consulting, Inc; Chicago (IL); Remote; Full time

Job summary

A leading company in the Electrical Logistics Industry is seeking a Drug Safety Scientist for a 12-month contract with remote flexibility. The role involves authoring aggregate safety reports, conducting pharmacovigilance activities, and ensuring compliance with health authority regulations. Ideal candidates will have extensive experience in pharmacovigilance and a solid educational background in science. This position offers competitive pay and comprehensive employee benefits.

Benefits

Health insurance (medical, dental, vision)

401(k) plan

Paid sick leave

Qualifications

• 5+ years of experience in pharmacovigilance including clinical and post-marketing.
• Ability to manage multiple projects while maintaining high quality.
• Strong knowledge of FDA, EU, ICH guidelines.

Responsibilities

• Author aggregate safety reports and produce high quality evaluation documents.
• Conduct routine signal detection and evaluate safety data.
• Support drug safety physicians in related issues.

Skills

Pharmacovigilance

Clinical Trial Experience

Post-Marketing Experience

Excellent oral and written communication skills

Attention to detail

Education

Bachelor’s or Master’s degree in science (Pharmacy, Biotechnology, or Chemistry)

Tools

Microsoft Word

PowerPoint

Excel

Job description

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.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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