Safety Officer II - Pharmacovigilance

Safety Officer II

QPS is a global, full-service CRO supporting pharmaceutical, biotechnology, and medical device companies throughout the drug development process. We are seeking an experienced Safety Officer II to join our growing Pharmacovigilance (PV) team. This is an exciting opportunity for a pharmacovigilance professional who enjoys working in a collaborative, client-facing environment while contributing to the safe development of innovative therapies.

In this role, you will be responsible for the evaluation, processing, and documentation of adverse event (AE) and serious adverse event (SAE) reports, ensuring timely and compliant safety reporting in accordance with global regulatory requirements, client expectations, and company procedures. You will serve as a key contributor to PV operations, supporting high-quality case processing activities and partnering with clients to deliver exceptional service.

If you are detail-oriented, analytical, and passionate about advancing patient safety, we encourage you to apply. Please note that this role does not meet eligibility requirements for visa support, such as H1B, L1, OPT, etc.; all applicants will need to be authorized to work in the U.S. on a permanent or unrestricted basis.

What You'll Do

• Perform intake, evaluation, processing, quality review, and documentation of AE and SAE reports within the Argus Safety Database, including case book-in, triage, data entry, coding, reconciliation, and follow-up activities, in accordance with regulatory requirements, client agreements, and company SOPs.
• Assess adverse event reports for seriousness, causality, expectedness, and regulatory reportability, ensuring the accuracy, completeness, timeliness, and integrity of safety case processing and pharmacovigilance records.
• Contribute to safety surveillance and aggregate safety reporting activities through the review and evaluation of safety data, identification of potential safety concerns, and collaboration with medical, clinical, and regulatory teams.
• Participate in client meetings and project discussions, providing project updates, responding to safety-related inquiries, and supporting cross-functional communication and issue resolution.
• Support inspection and audit readiness activities, including regulatory inspections, client audits, and compliance-related initiatives.
• Maintain current knowledge of evolving pharmacovigilance regulations, industry trends, and safety reporting requirements, and contribute to process improvements that support quality, compliance, and operational excellence.

Qualifications & Competencies

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related scientific discipline.
• Minimum of five (5) years of pharmacovigilance (PV), drug safety, or related experience.
• Strong knowledge of global pharmacovigilance regulations and industry standards.
• Experience evaluating safety information, including seriousness, expectedness, causality, and reportability assessments preferred.
• Experience working with safety databases, preferably Argus Safety.
• Experience performing SAE case intake, book-in, triage, data entry, and MedDRA coding.
• Strong attention to detail and commitment to quality.
• Excellent analytical and critical thinking skills with the ability to interpret complex safety information.
• Strong written and verbal communication skills.
• Ability to manage multiple priorities while working independently in a fast-paced environment.
• Experience within a CRO, pharmaceutical, biotechnology, clinical research, or healthcare environment preferred.
• Experience in client-facing pharmacovigilance roles preferred.
• Experience supporting regulatory inspections and audits preferred.

Work Environment

This position routinely uses standard office equipment and software, including computers, telephones, Microsoft Office applications, and the Argus Safety Database.

This role will be remote / 100% home-office based.

Why Join QPS?

At QPS, you'll be part of a collaborative and scientifically driven organization dedicated to accelerating drug development and improving patient outcomes worldwide. We value innovation, quality, integrity, and teamwork, and we invest in the professional growth of our employees.

Join a team where your expertise in pharmacovigilance and PV operations helps make a meaningful impact on patient safety and public health.

QPS is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law.