Safety & PV Operations Specialist II – Technology Support (ARGUS Console / Veeva Safety)
Updated: Yesterday
Location: Pune, Maharashtra, India
Job ID: 25101877-OTHLOC-5580-2DR
Employment Type: Full-Time
About Syneos Health
Syneos Health® is a global, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. By combining clinical development, medical affairs, and commercial expertise, Syneos Health helps sponsors navigate complex regulatory environments while keeping patients at the center of innovation.
With a workforce of more than 29,000 professionals across 110+ countries, Syneos Health has supported the majority of recent FDA and EMA approvals and continues to play a critical role in global pharmacovigilance and patient safety operations.
Role Overview
The Safety & PV Operations Specialist II – Technology Support plays a critical role in supporting pharmacovigilance systems and safety databases, with a strong focus on ARGUS Console or Veeva Vault Safety platforms. This position supports system configuration, maintenance, validation, and reporting activities to ensure compliance with global safety regulations and operational excellence across Safety and PV programs.
Key Responsibilities
General Responsibilities
Develop, maintain, and update job aids, work instructions, and process documentation, including supporting reference materials.
Ensure strict compliance with Standard Operating Procedures (SOPs), policies, and Safety Management Plans (SMPs).
Maintain working knowledge of FDA, EU, and ICH pharmacovigilance regulations and guidelines.
Support operational teams and project leadership to ensure accurate and timely business unit reporting and revenue recognition.
Prepare and deliver operational metrics and status reports at agreed intervals.
Perform additional duties as assigned in support of Safety and PV Operations initiatives.
Technology and Systems Support
Support the administration and maintenance of the safety database, including:
User access setup and maintenance
Project-level system configurations
Routine system patches and upgrades
MedDRA and WHO Drug Dictionary updates
Execution of Performance Qualification (PQ) scripts for system changes
Ongoing system compliance with regulatory reporting requirements
Assist with the maintenance and support of additional Safety and PV applications, including SharePoint and related tools.
Provide project-level support for safety database issues, system outputs, and data reconciliation activities.
Support safety data migration activities, including execution and validation.
Generate listings, queries, and reports from safety systems for internal review, client delivery, and regulatory submissions.
Participate in internal and project-specific meetings as required.
Maintain up-to-date expertise in Safety and PV systems through internal training, professional workshops, and industry seminars.
Support additional Safety, PV, and Technology initiatives as business needs evolve.
Required Qualifications
Education
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Computer Science, or a technology-related field, or
An equivalent combination of education and relevant experience.
Experience
3–6 years of experience in pharmacovigilance operations or safety systems support within a CRO, pharmaceutical, or biotech environment.
Hands-on experience with ARGUS Console and/or Veeva Vault Safety is strongly preferred.
Working knowledge of safety database systems and medical terminology.
Key Skills and Competencies
Strong understanding of ICH guidelines and global pharmacovigilance regulations.
Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Visio, Outlook).
Strong documentation, organizational, and analytical skills.
High attention to detail with the ability to meet tight deadlines.
Ability to manage multiple priorities in a fast-paced environment.
Excellent written and verbal communication skills in English.
Ability to work independently as well as collaboratively in cross-functional teams.
Sound decision-making and problem-solving capabilities.
Why Join Syneos Health
Contribute to safety systems supporting 94% of novel FDA-approved drugs and 95% of EMA-authorized products in recent years.
Be part of a globally diverse organization committed to professional growth, inclusion, and innovation.
Access continuous training, career development opportunities, and a competitive total rewards program.
Equal Opportunity Statement
Syneos Health is an equal opportunity employer and complies with all applicable employment laws and regulations, including providing reasonable accommodations for qualified individuals with disabilities.
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