Senior Specialist I, Postmarketing Patient Safety and Pharmacovigilance Operations

The role supports drug safety and pharmacovigilance activities in post-marketing setting focusing on supporting case management activities, particularly focused on the oversight of quality and compliance of vendor/service provider activities.

Responsibilities: 

• Support the oversight of drug safety/pharmacovigilance service providers to ensure the collection, processing, reporting and reconciliation of adverse events reports in compliance with global regulatory requirements
• Perform in line and/or end of line quality review of adverse event reports
• Assists in the creation/revision of department standard operating procedures and work instructions
• Development and delivery of training for safety related topics
• Support process improvement initiatives and safety systems activities
• Support and participate in audits and inspections, including preparation activities
• Assist with safety operations and/or safety science activities and projects, as necessary

Required Skills, Qualifications and Technical Proficiencies:

• Ability to work in a dynamic environment to meet patient and corporate needs
• Knowledge of Argus (or similar safety applications) and MedDRA and WHO Drug coding dictionaries
• Excellent communication and collaboration skills
• Ability to manage multiple projects in a fast-paced environment

Education and Experience:

• Bachelor's degree in healthcare or life sciences- degree such as RN or BSN, PharmD is preferred
• Minimum of 3 years Patient Safety & Pharmacovigilance experience in a global environment
• Experience in post marketing safety operations preferred
• Working knowledge of FDA, EU and ICH guidelines for safety reporting and processing for clinical trials and post marketing

The pay range that the Company reasonably expects to pay for this position is $103,600 – $137,100; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

 Applicants must be currently authorized to work in the United States on a full-time basis.