Pharmacovigilance Associate

TerSera Therapeutics LLC • Deerfield, IL

3d

About The Position

The Pharmacovigilance Associate supports the execution of pharmacovigilance activities across TerSera products under the direction and oversight of pharmacovigilance leadership. This entry level role contributes to safety surveillance, vendor oversight support, documentation, and inspection readiness activities within a highly regulated pharmaceutical environment.
The Pharmacovigilance Associate performs assigned activities in accordance with approved procedures and does not serve as a medical or regulatory decision authority. All work products are reviewed and approved by qualified pharmacovigilance leadership.

Requirements

• Foundational understanding of pharmacovigilance and patient safety concepts (or ability to acquire through training)
• Ability to interpret and summarize scientific and medical information
• Strong attention to detail and documentation practices
• Effective written and verbal communication skills
• Ability to work in a regulated environment with clear adherence to procedures
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint)
• Bachelor’s/Master’s degree in Pharmacy, Life Sciences, Nursing, or related scientific discipline
• Entry level; prior pharmacovigilance experience not required

Nice To Haves

• PharmD (preferred)
• Internship, academic coursework, or exposure to clinical research, medical affairs, regulatory affairs, or drug safety is a plus

Responsibilities

• Support internal oversight of pharmacovigilance vendors performing case processing, literature surveillance, and safety database activities
• Perform quality control (QC) reviews of vendor deliverables (e.g., case narratives, coding consistency, screening logs) under supervision
• Track vendor and/or license partner performance metrics, timelines, and reconciliation status
• Maintain pharmacovigilance oversight documentation and trackers
• Assist in the preparation of safety data summaries (e.g., line listings, trend summaries) for internal review
• Support signal detection activities by compiling and organizing safety data for review by senior PV staff
• Assist with reference verification, data checks, and formatting support for aggregate safety reports (e.g., PADERs, DSURs), under supervision
• Participate as an observer in safety governance and vendor oversight meetings
• Maintain PV training records, logs, and documentation in accordance with company procedures
• Support SOP lifecycle activities, including formatting, document control coordination, and training assignment tracking
• Assist with preparation of inspection materials and internal PV evidence binders
• Support documentation and tracking of deviations, CAPAs, and action items related to PV activities
• Collaborate with PV, Quality Assurance, Regulatory Affairs, Medical Affairs, and Clinical Operations colleagues as directed
• Participate in structured pharmacovigilance training and mentorship program
• Progressively expand responsibilities based on demonstrated competency and documented training completion.
• Strives to maintain a safe working environment through the prevention of accidents, the preservation of equipment, and the achievement of safe working practices
• Maintains a positive and professional demeanor toward all customers and coworkers
• Adheres to all policies and procedures of TerSera Therapeutics
• Performs other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 101-250 employees