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

Job Tags

Contract work, Work experience placement,

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