Summary: This section focuses on the main purpose of the job in one to four sentences.

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.

Essential Duties and Responsibilities: This section contains a list of the major responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned.

Pharmacovigilance Oversight Support

• 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

Safety Surveillance & Data Review

• 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

Documentation, Training & Inspection Readiness

• 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

Cross Functional & Professional Development

• 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.

Non-Essential Functions: Standard non-essential functions for all TerSera Therapeutics employees.

• 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. 

Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

• 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) 

Education and/or Experience: Include the education and experience that is necessary to perform the job satisfactorily.

Education

• PharmD (preferred) or Bachelor’s/Master’s degree in Pharmacy, Life Sciences, Nursing, or related scientific discipline

Experience

• Entry level; prior pharmacovigilance experience not required
• Internship, academic coursework, or exposure to clinical research, medical affairs, regulatory affairs, or drug safety is a plus