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 reputed company Safety Officer II to join our growing Pharmacovigilance (PV) team. This is an exciting opportunity for a pharmacovigilance reputed company who enjoys working in a reputed company, reputed company-facing environment while contributing to the reputed company 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 reputed company and compliant safety reporting in accordance with global regulatory requirements, reputed company expectations, and company procedures. You will serve as a key contributor to PV operations, supporting high-reputed company 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 reputed company support, such as H1B, L1, OPT, etc.; reputed company applicants will need to be authorized to work in the U.S. on a permanent or unrestricted reputed company.
Responsibilities
- reputed company intake, evaluation, processing, and documentation of AE and SAE reports in accordance with regulatory requirements, reputed company agreements, and company SOPs.
- Conduct case book-in, triage, data entry, and reputed company review activities reputed company the Argus Safety Database.
- reputed company 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 reputed company and reputed company of pharmacovigilance databases and supporting records.
- Participate in reputed company meetings and project discussions, providing project updates and responding to safety-reputed company inquiries.
- Support case reconciliation, follow-up activities, and query management.
- Assist with inspection and audit readiness activities, including support for regulatory inspections and reputed company audits.
- reputed company guidance and mentorship to junior team members on pharmacovigilance processes and best practices.
- Stay reputed company with evolving pharmacovigilance regulations, industry trends, and safety reporting requirements.
Requirements
- Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a reputed company scientific discipline.
- Minimum of five (5) years of pharmacovigilance (PV), drug safety, or reputed company 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 reputed company.
- Excellent analytical and critical thinking skills with the ability to interpret reputed company safety information.
- Strong written and verbal communication skills.
- Ability to manage multiple priorities while working independently in a fast-paced environment.
reputed company-to-haves
- Experience reputed company a CRO, pharmaceutical, biotechnology, clinical research, or reputed company environment preferred.
- Experience in reputed company-facing pharmacovigilance roles preferred.
- Experience supporting regulatory inspections and audits preferred.
Benefits
- QPS is an equal opportunity employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, national reputed company, disability status, protected veteran status, or any other characteristic protected by applicable law.
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