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location: Northbrook, Illinois
job type: Contract
salary: $77.53 - 91.22 per hour
work hours: 9 to 5
- Participate in or lead safety management teams for clinical programs.
- Serve as the safety point of contact to other colleagues (RA, QA, Medical Affairs)
- Create regulatory reports and analytical papers, gathering and categorizing data, providing initial medical analysis and/or overall benefit/risk.
- Create, or assist in creating:
- PBRERs, DSURs, PADERs
- Signal detection activities
- Create and/or review safety portions of submission documents
- Ability to participate in bridging communications between business and safety to ensure appropriate safety context is conveyed.
- Physician with relevant, hands on safety experience.
- At least 3 years of hands on PV experience in clinical and/or post marketing
- Solid understanding of regulations impacting Pharma industry in the US and globally, especially drug safety/ PV
- Hands on experience writing/reviewing Aggregate Reports , e.g., PBRERs, DSURs, and PADERs
- Hands on experience with signal detection activities such as analyzing/categorizing/
- assessing data
- Strong leadership skills
- Excellent oral and written communication skills
- Excellent listening and comprehension skills
- Ability to work effectively in a matrix setting to resolve issues and achieve common goals
skills: Pharmacovigilance, Drug Safety, DSUR (Development Safety Update Report), Regulatory Affairs Operations, Submissions, PBRER (periodic Benefit Risk Evaluation Report)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.