A New Jersey-based biotech company is actively seeking a new Associate Director of Global Drug Safety & Pharmacovigilance Data Management to join its growing team.

About the Opportunity:
- Schedule: Full-time
- Hours: Standard business
- Setting: Hybrid (at least 2 days a week onsite)
Responsibilities:
- Triaging and reviewing Argus configuration requests
- Conducting strategic UAT, including test planning and execution
- Ensuring compliance with ICH E2B(R2) and (R3) conventions
- Managing communication with stakeholders and escalating issues
- Participating in safety application projects as a business SME
- Performing other duties, as needed
Qualifications:
- Experience in Oracle Argus Safety system configuration and administration
- Expertise in ICH E2B(R2) and ICH E2B(R3) conventions
- Experience with safety case processing and ICSR reporting
- Knowledge of PV regulations and guidance
- Ability to produce audit-ready UAT documentation
- Stakeholder management skills
- Strong communication skills
- Ability to translate business needs into system requirements
- Attention to detail
Desired Skills:
- Advanced Degree in a related field
- Additional experience in Argus Safety
- Applicable certifications
- Proficiency in Regulatory compliance
