Company: Planet Pharma
Location: North Chicago
Posted on: May 3, 2021
- Responsible for standard surveillance activities for a
product’s life cycle (one or more assigned compounds and products)
through review of safety data from clinical trials, safety
databases, and the literature.
- Collaborates with safety and clinical teams to develop
strategies and approaches for signal assessments and regulatory
requests by analyzing data from multiple sources.
- Analyzes data to support signal assessment and contributes to
ad hoc regulatory safety requests using data from multiple sources
- Utilizes medical judgment to determine the impact of identified
safety issues on the compound/ product’s benefit-risk profile.
- Communicates findings of surveillance activities and safety
assessments to product teams and leadership to inform on necessary
risk minimization activities, including label changes.
- Collaborative preparation and maintenance of safety sections of
Clinical Summary of Safety, Clinical Study Reports, Company Core
Data Sheets and Risk Management Plan.
- Support strategy development, authorship and review of global
aggregate safety reports in accordance with regulatory requirements
and standard operating procedures with supervision.
- Prepares summaries of key safety data for PST, SRB, senior
management, Advisory and other similar meetings with
- Proficient in pharmacovigilance regulations, guidelines, and
company standard operating procedures
- In depth understanding of compounds within assigned therapeutic
areas, including safety profile and where applicable, labeling,
literature, clinical and regulatory issues.
- Degree in a Health Sciences (e.g., Pharmacy, Epidemiology,
o Bachelors + 2 years clinical/pharma or safety work
o Masters or doctorate, 1-2 years clinical/pharma or safety work
experience (e.g. MPH, PharmD, PhD, or Masters in a Health
- Knowledge of the drug development process which includes
conducting clinical trials, scientific strategy and operations
management for the planning, execution and reporting of clinical
development programs, regulatory requirements for submission,
product launch and post marketing support.
- Understanding of tools, standards and approaches used to
efficiently evaluate drug safety is desirable, not required.
- Familiar with working in a multidisciplinary, matrix team
- Effective oral and written communication skills with the
ability to manage multiple projects simultaneously
- Microsoft WORD and EXCEL skills and Basic Project Management
- Able to work independently with guidance from manager
Keywords: Planet Pharma, Waukegan , Safety Reviewer, Other , North Chicago, Illinois
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