Safety Officer II Pharmacovigilance

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.

• 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.

• Bachelors 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.

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.

At QPS youll 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.