Contractor, Safety Systems

Job#: 3043177

Job Description:
Contractor, Safety Systems (Pharmacovigilance)

Our biotech client is seeking an experienced Contractor, Safety Systems to support the administration, maintenance, and optimization of global pharmacovigilance (PV) safety systems. This individual will serve as a subject matter expert for safety databases and reporting tools, ensuring compliance, system integrity, and operational efficiency across global safety operations.
Key Responsibilities

• Administer and maintain global safety systems, including configurations, code lists, reporting rules, user access, and data validation controls.
• Configure new studies, products, and licenses within safety databases.
• Manage onboarding/offboarding activities and system access for internal teams and external vendors.
• Support system upgrades, enhancements, data migrations, and process improvement initiatives.
• Troubleshoot system issues and coordinate with vendors to drive timely resolution.
• Develop and maintain safety reports, queries, and data extracts for aggregate reporting, signal detection, and ad hoc business needs.
• Maintain SOPs, work instructions, and system documentation.
• Perform routine maintenance activities, including dictionary updates, user access reviews, and reporting rule reviews.
• Support regulatory inspections, audits, and training activities.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Public Health, or a related healthcare discipline; advanced degree preferred.
• 8+ years of pharmacovigilance and/or drug safety systems experience.
• Deep expertise with Oracle Argus and experience with safety platforms such as ArisGlobal, Veeva, and PV reporting tools.
• Strong understanding of pharmacovigilance regulations, Good Pharmacovigilance Practices (GVP), and drug safety processes.
• Experience with safety system configuration, validation, upgrades, reporting, and maintenance within a regulated environment.
• Strong analytical, organizational, problem-solving, and communication skills.
• Experience with SQL, data mining, reporting tools, Argus upgrades, dictionary updates, and data migrations is highly preferred.

Preferred Experience

• Oversight of safety system vendors and external partners.
• Experience supporting clinical development programs and regulatory submissions.
• Ability to manage multiple priorities in a fast-paced environment while maintaining exceptional attention to detail.

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

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