Patient Safety Associate I (Drug Safety Associate I)
New
J
JobgetherPharmacovigilance
Based in United StatesFull-TimeEntry
Salary not disclosed
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Job Details
- Experience
- 3+ years of drug safety experience is preferred; at least 2 years of post-marketing safety experience.
- Required Skills
- Microsoft Office
Requirements
- Bachelor’s degree in Life Sciences, Health Sciences, Biomedical Sciences, Pharmacy, Microbiology, Biochemistry, Biotechnology, or a related discipline.
- Foundational knowledge of pharmacovigilance processes and drug safety regulations.
- At least 2 years of post-marketing safety experience.
- Experience working across multiple therapeutic areas, such as cardiology, neurology, oncology, or rare diseases.
- Experience with pharmacovigilance systems, safety databases, and established workflows.
- Proficiency in Microsoft Office applications.
- Strong attention to detail, organization, analytical thinking, and problem-solving skills.
- Ability to manage data and documentation accurately while meeting deadlines.
- Clear written and verbal communication skills.
- Patient-focused mindset with a strong commitment to quality and compliance.
- 3+ years of drug safety experience is preferred.
- Veeva Safety experience is preferred.
Responsibilities
- Monitor incoming safety reports from multiple sources and support the timely processing of pharmacovigilance data.
- Perform case creation, data entry, case processing, quality checks, medical coding, follow-up activities, and case narrative preparation.
- Support regulatory compliance by accurately processing, documenting, reconciling, and tracking safety cases and submissions.
- Prepare and support the submission of Individual Case Safety Reports, periodic reports, and related documentation.
- Conduct literature searches and reviews to identify potential safety information.
- Support affiliate services, including safety information exchange, literature screening coordination, and data reconciliation.
- Maintain accurate project documentation, records, and files across relevant systems.
- Support regulatory operations through database maintenance, submission tracking, and registration activities.
- Collaborate with global colleagues and cross-functional stakeholders.
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