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Medical Reviewer/Safety Reviewer III
100 Park Ave Florham Park, NJ 07932 US
Job Description
Target PR Range: 40-50/hr
*Depending one experience
Job Description:
The Medical Device Safety team is a highly diverse department that plays a critical role in conceptualizing, designing, and implementing high-priority analytical strategies, clinical oversight, and initiatives. The team is a high-profile high-impact team that works with PSEQ functions on a range of product initiatives. As a member of the team, you are at the forefront of working with leaders to identify critical priorities and drive high-value projects that make an impact on safety of our patients.
Experience & Skills:
Proficient in Microsoft Office tools, Data Analysis, Research, Data Automation, Case processing of Device SAE/AEs, device complaints and SADE potential cases
Knowledge of Research & Development and an understanding of regulatory guidelines / requirements related to R & D Medical Devices / Combination Products (e.g., ICH, GCP, CFR, EU-MDR, safety reporting)
Clinical Trial Experience
Clinical Trial Device Experience
Knowledge of electronic databases (e.g., TrackWise, Business Objects, Oracle, Veeva, Argus, EDC Rave, Veeva EDC other database tools)
Ability to effectively interact with and influence others without direct reporting relationships
Ability to multi-task and prioritize while maintaining attention to detail with high quality outputs
Core Essential Skills:
Ability to Meet Challenging Milestones with results orientation – Skilled
Strategic Decision Making and Negotiation – Skilled
Facilitating Change and managing conflicts – Skilled
Ability to Problem Solve Independently & with Others - Highly Skilled
Business Organization & Industry Awareness - Highly Skilled
Cross Functional Relationships and communication skills - Highly Skilled
Execution / Results / Process Improvement - Highly Skilled
Background / Required and Preferred Education Level:
Bachelor of Science in Nursing or Bachelor of Science with Major in Nursing
RN Required
*CO/NYC candidates might not be considered
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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