Senior Drug Safety Specialist (Clinical Trial) - REMOTE - US Hours
We are hiring for a Pharmacovigilance in Clinical Trial case processing. This is a remote job, which you'll be supporting the US client in life sciences.
Remote job / Direct hire / Full-time employment / Equipment provided
Qualifications:
- BS Degree in Nursing OR Pharmacy.
- Hold Pharmacovigilance experience in data entry and peer review-Clinical Trial Case processing experience mandatory for 3 years and above
- Clinical Trial case processing experience (MUST-HAVE)
- Experience in handling clinical trial protocols, Study specific sheets
- Experience in clinical safety database like Argus, Aris G, Medidata Rave, Veeva Vault Safety
- High expertise with the use of Arisg and Argus database for pharmacovigilance data management.
- Post Marketing experience - reports
- • Manage linking of cases, duplicate reports, nullification and invalid reports.
- • Highly trained for data entry and quality review of medical report.
- • Expertise in MedDRA and WHODD coding activities.
- • Knowledgeable in understanding of medical terminology, clinical research, drug development, regulatory
- guidelines, pharmacovigilance processes.
- • Knowledge of medical terms, disease classifications, and physiological processes.
- • Perform primary review by assessing validity and seriousness of the case.
- • Determine causality, listedness and expectedness between the events and suspect product.
- • Develop and maintain expertise and knowledge of all products within the company’s portfolio.
- • Review guidelines, standard operating procedure and narrative writing conventions.
- • Attention to detail, critical thinking, problem-solving, and teamwork.
- • Knowledgeable in regulatory requirements and timelines for reporting adverse events.
- • Knowledge of clinical trial phases, adverse event reporting, causality assessment, and expectedness.
- • Understanding of international and local regulations related to clinical trial safety (e.g., ICH, FDA).
- • Process spontaneous reports, non-interventional study, compassionate use, SUSARs, legal, and literature
- reports
- • Collaborate with team to ensure standard operating procedures, work instructions and product reference
- guides are being followed to ensure accurate medical reporting.
- • Collaborate and work closely with other departments such as Medical Reviewers Drug Safety Unit to
- ensure no discrepancies are found in the medical report.
- • Able to train and mentor new team members and colleagues, fostering
