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.
PROVEN SCIENTIFIC PLACEMENT
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.
Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRateds Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.
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