Syneos Health, a global leader in biopharmaceutical solutions, is hiring a Safety & PV Ops Specialist II (Technology Support) for its remote Pune-based team. This position offers an exciting opportunity for professionals skilled in ARGUS Console or Veeva Vault Safety to play a vital role in pharmacovigilance (PV) and safety operations technology management.
At Syneos Health, your work directly contributes to accelerating the delivery of life-saving therapies. The organization thrives on innovation, teamwork, and global collaboration—values that make it one of the most desirable employers in the clinical research and pharmacovigilance sectors.
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Key Responsibilities
- Manage and maintain the safety database (user setup, MedDRA updates, PQ scripts, performance checks).
- Support database configurations, data migrations, and report generation.
- Ensure regulatory compliance with FDA, EU, and ICH guidelines for PV reporting.
- Develop and maintain Job Aids, SOPs, and process documentation.
- Provide technology support for safety and PV systems like SharePoint and ARGUS Console.
- Collaborate with teams to deliver accurate datasets for analysis and ensure seamless safety reporting workflows.
- Contribute to system improvement initiatives and participate in project meetings.
Qualifications & Experience
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Computer Science, or related field.
- Hands-on experience with ARGUS Console or Veeva Vault Safety.
- Strong knowledge of ICH-GCP, FDA, and EU PV regulations.
- Proficiency in Microsoft Office Suite (Word, Excel, Visio, PowerPoint).
- Excellent communication, analytical, and documentation skills.
- Ability to manage multiple priorities and work independently.
- Detail-oriented with a strong sense of compliance and accuracy.
Why Join Syneos Health
- Work remotely while contributing to global drug safety.
- Competitive compensation and performance-based rewards.
- Continuous career development and skill advancement opportunities.
- Inclusive “Total Self” culture that values authenticity and diversity.
- Be part of a company trusted by 94% of all novel FDA-approved drugs and 95% of EMA-authorized products.
How to Apply
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