Drug Safety Associate II, Pharmacovigilance – Remote (US)
Are you an experienced health vigilance professional looking for a challenging and rewarding opportunity? Join our team as a Drug Safety Associate II, working remotely within the United States. In this role, you will play a key part in ensuring drug safety by monitoring, analyzing, and reporting adverse events, ultimately contributing to patient safety and regulatory compliance.
The Role of Drug Safety Associate
As a Drug Safety Associate II, you will be responsible for case processing, safety data analysis, and compliance reporting. Your work will ensure that pharmaceutical and biotech companies remain in full compliance with FDA, EMA, and global pharmacovigilance regulations. This role requires strong analytical skills, regulatory knowledge, and attention to detail to handle safety reports efficiently.
Key Responsibilities of Drug Safety Associate
- Adverse Event Case Processing: Collect, assess, and document adverse drug reactions (ADRs) from clinical trials, healthcare professionals, and patient reports.
- Data Entry & Coding: Accurately enter case details into safety databases such as Argus, ArisG, or Veeva Vault, ensuring consistency with MedDRA and WHO Drug Dictionary.
- Regulatory Reporting: Ensure timely and accurate submission of Individual Case Safety Reports (ICSRs) and Periodic Safety Reports (PADERs, PSURs, DSURs) to regulatory authorities.
- Signal Detection & Risk Management: assist in the identification of safety trends, potential safety signals, and risk assessments related to drug products.
- Collaboration: Work closely with Regulatory Affairs, Quality Assurance, Medical Affairs, and Clinical Research teams to ensure accurate and efficient pharmacovigilance processes.
- Process Improvement: Contribute to enhancing pharmacovigilance workflows, ensuring compliance with evolving global safety regulations and best practices.
- Audits & Inspections: Support internal audits and regulatory inspections, maintaining high standards of documentation and compliance.
- Literature Review: Conduct scientific literature searches to identify potential safety issues associated with drugs and report findings accordingly.
Qualifications & Skills of Drug Safety Associate
To succeed in this role, you should have:
- A bachelor’s degree in pharmacy, nursing, life sciences, biomedical sciences, or a related field (advanced degrees preferred).
- 2+ years of experience in pharmacovigilance, drug safety, or clinical research within a pharmaceutical or biotech company, CRO, or regulatory agency.
- Strong understanding of FDA, EMA, ICH, and MHRA regulations for drug safety and reporting.
- Hands-on experience with pharmacovigilance databases such as Argus, ArisG, or Veeva Vault.
- Proficiency in MedDRA coding and WHO Drug Dictionary.
- Strong analytical skills, attention to detail, and the ability to manage multiple priorities in a fast-paced environment.
- Excellent written and verbal communication skills, especially for regulatory documentation and stakeholder collaboration.
- Ability to work independently in a remote environment while maintaining high levels of accuracy and compliance.
Why Drug Safety Associate Join Us?
Working as a Drug Safety Associate II offers an opportunity to be part of a mission-driven team focused on ensuring drug safety and improving public health. Here’s why you should consider this role:
✔ 100% Remote Work: Work from anywhere within the United States with flexible work arrangements.
✔ Career Growth: Gain experience in a rapidly growing field with potential for career advancement in pharmacovigilance and regulatory affairs.
✔ Collaborative Team: Work alongside experienced drug safety professionals, medical experts, and regulatory specialists.
✔ Impactful Work: Contribute to the safety of pharmaceuticals and help prevent adverse drug reactions that could affect patient health.
✔ Competitive Compensation: Receive a competitive salary, benefits package, and professional development opportunities.
About the Drug Safety Associate Us
Drug Safety Associates is a leading pharmaceutical and biotech services company specializing in pharmacovigilance, regulatory compliance, and clinical research. The Drug Safety Associate team is dedicated to ensuring the safety and efficacy of medical products, working closely with healthcare professionals, regulatory agencies, and industry leaders.
How to Apply as a Drug Safety Associate
If you are passionate about pharmacovigilance, drug safety, and regulatory compliance, we invite you to apply for this exciting opportunity. Submit your resume today and take the next step in your drug safety career!