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US_Drug Safety Consultant II

TalentBurst, Inc.

Chicago, IL(remote)

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JOB DETAILS
SKILLS
Analysis Skills, Biology, Clinical Information, Clinical Practices/Protocols, Clinical Support, Clinical Trial, Computer Skills, Consulting, Cross-Functional, Data Analysis, Documentation, Management Strategy, Medical Dictionary for Regulatory Activities (MedDRA), Multitasking, Natural Science, Operations Management, Pharmacovigilance, Problem Solving Skills, Process Safety Management, Product Reviews, Product Safety, Regulations, Risk, Risk Analysis, Risk Management, Safety Process
LOCATION
Chicago, IL
POSTED
30+ days ago

Title: US_Drug Safety Consultant II/PV Scientist
Location: Remote
Duration: 6 Months

Description:
PV Scientist serves as a product lead for Pharmacovigilance activities within Safety. The PV Scientist may be responsible for overseeing day to day safety operations of clinical trials for the assigned product(s), supporting and/or leading the process for safety signal management activities, aggregate reports (PSURs, DSURs, Line Listings) and RMPs, responding to safety questions from internal and external stakeholders, reviewing medical and scientific literature for safety information, and supporting Clinical Trial PV activities. The PV Scientist also serves as a Subject Matter Expert for Safety and cross-functional teams on relevant global safety regulations and guidelines; data output and analyses; and product specific information.

What You'll Do
Support and/or leads the signal management process (i.e., signal detection, signal tracking, signal documentation, facilitating decisions regarding signals and safety risk, etc.) for assigned product(s) and evaluates safety data and signals as part of ongoing pharmacovigilance activities. Includes synthesis of data from multiple sources and authoring signal evaluation reports. Support and/or leads signaling review process and product Safety Signaling Team meetings. Manages literature review for safety information.
Support and/or leads process for responding to safety questions from regulatory authorities while collaborating with cross-functional team as necessary.
Support and/or leads Aggregate Report management, including strategy, review and finalization of aggregate safety reports for assigned products, such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Plans (REMS), and Risk Management Plans (RMPs).
Collaborates with Global Safety Officers and other Safety MDs for assigned investigational programs including clinical trial activities (protocol review, ICF review, etc.), safety committee management, data analysis, signal detection, ad hoc requests and other product activities, as assigned to ensure alignment with safety strategy and risk communications.
Responsible for day-to-day safety operations and safety management plans for assigned clinical trials
Qualifications Required Skills
  • Minimum 7 years Pharmacovigilance experience, including experience in aggregate safety reports and safety signal management experience.
  • Bachelor's Degree in biologic or natural science; or health case discipline required. Advanced degree (PhD, MPH, NP, PharmD, etc.) preferred.
  • Knowledge of MedDRA terminology and its application
  • Must have excellent analytical and problem-solving ability
  • Strong computer skills and advanced application MS capability desirable, particularly Excel
  • Ability to work in fast-paced environment with multiple competing priorities.

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Why TalentBurst?
At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.

Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.

We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.

About the Company

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TalentBurst, Inc.

For over 20 years, TalentBurst Inc. has been an award-winning provider of cutting-edge Workforce Management Solutions. With a strong commitment to staying ahead in the tech landscape, we pioneer innovative approaches to talent acquisition. Our expertise spans Life Sciences, and Healthcare Staffing, Banking, Financial, IT, and Engineering, as well as Global Employer of Record (EOR), Agent of Record (AOR), State, Local Government and Education (SLED), and IC validation/compliance services. Additionally, our division, TalentProcure, leads the industry with offerings such as High Hazard Payroll, Managed Services, and Vendor on Premise (VOP) solutions.

Due to our prioritization of excellent standards, we are Joint Commission Certified and are a certified Minority Business Enterprise (MBE) in the USA and Canada. Supporting over 130 Fortune 500 companies globally, we excel in navigating the landscape of talent acquisition. In a world of constant change, we embrace developing people-centric solutions that address the unique demands of our clients. Stay connected by visiting our website and following us on social media!

 

COMPANY SIZE
5,000 to 9,999 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
2002
WEBSITE
http://www.talentburst.com/