Drug Safety Specialist

Planet Pharma; South San Francisco (CA); Remote; Full time

Job summary

Join a leading company as a Drug Safety Specialist where you will be responsible for case processing of serious adverse events and product-related information. The role requires strong analytical skills, a relevant degree, and at least 2 years of relevant experience, providing a unique opportunity within the pharmacovigilance sector. This fully remote position is ideal for detail-oriented professionals seeking to make an impact in drug safety.

Qualifications

• 2+ years of recent case processing experience, including post-marketing cases.
• Fluency in English with excellent written and verbal communication skills.
• Capability to perform database/literature searches.

Responsibilities

• Reviews, processes, and assesses adverse event reports from clinical trials.
• Prepares and submits safety reports to regulatory authorities.
• Collaborates with cross-functional teams for accurate reporting of adverse events.

Skills

Analytical skills

Problem-solving skills

Detail oriented

Communication skills

Teamwork

Education

Degree in Pharmacy, Nursing, Life Science, or equivalent

Tools

MedDRA and WHODrug coding

RxLogix’s Pharmacovigilance Case Management system

Job description

Join to apply for the Drug Safety Specialist role at Planet Pharma

Join to apply for the Drug Safety Specialist role at Planet Pharma

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.

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
  

The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Management and Manufacturing

• Industries

  Staffing and Recruiting

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