Safety Officer II - Pharmacovigilance
About the position 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.
Responsibilities
- Perform intake, evaluation, processing, and documentation of AE and SAE reports in accordance with regulatory requirements, client agreements, and company SOPs.
- Conduct case book-in, triage, data entry, and quality review activities within the Argus Safety Database.
- Code adverse events, medical histories, indications, and medications using MedDRA and other applicable coding dictionaries.
- Ensure the accuracy, completeness, and timeliness of safety case processing and documentation.
- Maintain the integrity and quality of pharmacovigilance databases and supporting records.
- Participate in client meetings and project discussions, providing project updates and responding to safety-related inquiries.
- Support case reconciliation, follow-up activities, and query management.
- Assist with inspection and audit readiness activities, including support for regulatory inspections and client audits.
- Provide guidance and mentorship to junior team members on pharmacovigilance processes and best practices.
- Stay current with evolving pharmacovigilance regulations, industry trends, and safety reporting requirements.
Requirements
- 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 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.
Nice-to-haves
- 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.
Benefits
- 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.