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Drug Safety Specialist
Job Description
Pay range: 61-64/hr
*depending on experience
DRUG SAFETY SPECIALIST
POSITION SUMMARY:
The Drug Safety Specialist is primarily responsible for case processing of serious adverse events, serious and non-serious adverse drug reactions and other medically related project information such as adverse events of special interest and product complaints.
This position is fully remote.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
· Reviews, processes, and assesses adverse event reports (AERs) from clinical trials and post-marketing sources
· Enters and maintains safety data in the global safety database
· Prepares and submits safety reports to regulatory authorities in accordance with global safety reporting requirements
· Performs QC of cases to ensure quality levels are maintained per DOB’s expectations
· Manages the safety intake mailbox including the triage of incoming reports for completeness, legibility, and validity
· Query management
· Maintains electronic documentation for case files within the safety database
· Assists with reconciliation of the safety and clinical trial databases
· Collaborates with cross-functional teams to ensure timely and accurate reporting of adverse events to regulatory agencies
· Adheres to all relevant pharmacovigilance regulations and company policies
· Assists in development of project-specific safety procedures, workflows, and templates.
· Assists in project-specific safety database setup, management of data entry guidelines, and user acceptance testing.
· MedDRA and WHODrug coding in the safety database
· Preparation for, participation in, and follow-up on audits and inspections
· Provides training and guidance to colleagues on drug safety processes and procedures.
· Stays updated on industry developments and changes in drug safety regulations.
· Maintains confidentiality and adheres to ethical standards in handling sensitive and confidential information.
· Performs other duties and responsibilities as assigned by management.
QUALIFICATIONS
· Degree in Pharmacy, Nursing, Life Science, or other fields, or equivalent qualification/work experience
· The ideal candidate will have 2+ years of recent case processing experience and must include experience processing post-marketing cases
· MedDRA and WHODrug coding experience
· Must be fluent in English with excellent written and verbal communication skills
· Detail orientated and capable of working effectively within a team environment.
· Excellent organizational and prioritization skills
· Analytical and problem-solving skills
· Able to perform database/literature searches
· Experience working in RxLogix’s Pharmacovigilance Case Management system a plus
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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