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Analyst, Product Surveillance
26531 Ynez Road Temecula, CA 92591 US
Job Description
Education: Four-year degree, preferably in the healthcare or science fields; or 2-year degree and relevant experience supporting complaint handling investigations, medical device reporting, or product analysis. Degreed applicants without medical, scientific, or complaint handling experience may be considered if they possess the strengths suitable for this position.
Duties: May perform multiple functions within the postmarket surveillance department. Major responsibilities would include determining classification, review, and disposition of adverse events and medically related complaints for on-market products, including decisions on seriousness, reportability, and potential causality. Complete FDA MDR and other outside competent authority regulatory reports.
• Med device – regulated by FDA, taking product complaints from Account Managers, sales managers, from cath lab, physicians, taking phone calls, data entry, analyzing complaints for reportability to competent authorities, reviewing reports, etc.
• 4-year BA Degree highly preferred - new graduates okay; Degree – open to type: biology, biotech, engineering good fits (Life sciences). Masters okay as long as they are interested in position long term as this is a 2 year contract.
• 2-year degree with 2+ years complaint handling experience okay
• PhD/MBA candidates considered overqualified
• Critical thinking skills required
• Previous compliant experience preferred
• Need to have good documentation skills
• Previous med device experience nice to have
• Previous quality experience nice to have
• Entering data into online management system; Salesforce platform will be used – custom to group
• Reference documents and apply to daily work
• Organized, self-motivated, team player
• Good written and verbal communication
• MS Office experience preferred
• Worker will be assigned to team that work in same product group – will work with trainer daily until they are certified, 4-6 months of training
• Interview Process: Initial video screen, 1 follow up interview with selected candidates from screening
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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