Pharmacovigilance Associate

Role overview

This remote full-time position is for a Pharmacovigilance Associate supporting safety operations and case processing within a global drug safety function. The role requires 1 to 2 years of hands-on pharmacovigilance experience and strong capability with safety databases. The main objective is to ensure Individual Case Safety Reports (ICSRs) are received, processed, reported, and reconciled accurately, on time, and in line with global regulatory expectations and internal procedures.

Core responsibilities

• Handle adverse event and special situation cases end to end, including intake, triage, data entry, follow-up, narrative preparation, coding, and quality review in the safety database, following SOPs and applicable regulations.
• Apply medical coding using MedDRA and WHO Drug, or the company’s chosen dictionaries, and assist with dictionary updates and associated quality review activities.
• Support timely regulatory submissions and distribution steps, including determining seriousness, expectedness, and reportability according to procedure.
• Carry out case quality checks, address data queries, document decisions, and keep records ready for inspection.
• Assist with safety database operations such as case lifecycle handling, duplicate search and merge support, data cleansing, and workflow oversight.
• Reconcile safety information against clinical, medical information, product quality, and partner data sources, then investigate gaps and support scheduled reconciliation activities.
• Track operational performance metrics such as throughput, timeliness, and quality, identify root causes behind trends, and recommend process enhancements.
• Work closely with Clinical Operations, Medical Affairs, Quality, Regulatory, vendors, and partners to collect follow-up details, close queries, and maintain consistent safety data.
• Help prepare for inspections and audits by maintaining accurate documentation and supporting request responses under supervision.
• Contribute to ongoing improvements in pharmacovigilance procedures, templates, and work instructions.
• Assist with cross-functional safety review meetings by sharing materials and documenting meeting minutes.

Required background

• 1 to 2 years of experience in drug safety or pharmacovigilance, including direct ICSR case processing.
• Practical experience using safety databases for the full case workflow, from intake through submission or distribution, along with follow-up and data quality tasks.
• Working knowledge of global pharmacovigilance regulations and guidance, such as ICH E2A, E2B(R3), E2D, and FDA/EMA reporting concepts, plus PV SOPs.
• Familiarity with medical coding practices and safety data quality standards.
• Strong attention to detail, procedural discipline, and a firm commitment to data integrity and compliance.
• Clear written and verbal communication skills, including the ability to turn case details into concise narratives.
• Ability to balance multiple priorities and deliver within deadlines in a high-volume setting.
• Bachelor’s degree in life sciences, pharmacy, nursing, public health, or a related discipline, or equivalent experience.

Preferred experience

• Experience with safety data reconciliation between clinical and safety systems, partner data exchange, or case distribution workflows.
• Exposure to safety reporting gateways and E2B(R3) transmission concepts.
• Background supporting periodic safety reporting tasks such as DSUR, PSUR, or PBRER, or signal detection support work.
• Prior work with vendors or CROs and case processing metrics or KPIs.
• Experience in a GxP-regulated environment with exposure to audits or inspections.

Working schedule and environment

This is a full-time remote role. Standard working days are Monday through Friday, generally from about 8:30 AM to 5:00 PM, depending on the day’s schedule. Occasional work outside these hours may be needed, including evenings and weekends, based on business requirements. The role is performed in a professional virtual setting, typically from a home office, and may involve collaboration across time zones to meet global case processing timelines.

Travel and physical requirements

Travel is rare, but up to 5% may be required for meetings or conferences. The position involves extended computer-based work with sustained attention to detail while handling confidential safety information. From a home-office setting, the job may require prolonged sitting, typing, and use of standard office equipment, as well as occasional standing, walking, speaking, hearing, and lifting or moving items up to 25 pounds.

Compensation and benefits

The annual salary range for this position is $70,000 to $85,000. Candidates with stronger skills or more relevant experience may be considered for higher compensation. The total offer may also include a competitive base salary, an annual bonus target, and a robust benefits package. Final pay will depend on experience, qualifications, location, and other legally permitted job-related factors.

Additional information

This job description is intended as a general overview and does not list every task or responsibility that may be assigned. Duties may change at any time, with or without notice. The employer does not accept unsolicited resumes or candidates submitted by outside staffing agencies or recruiters. Equal employment opportunity is provided to all qualified applicants regardless of race, color, religion, sex, gender identity, sexual orientation, national origin, ethnicity, age, disability, marital status, protected veteran status, or any other legally protected characteristic.