Safety & PV Technology Project Manager

Why This Role Matters
The Safety & PV Technology Project Manager role is critical in advancing pharmacovigilance operations through digital innovation. By integrating AI and automation into drug safety systems, this position enhances efficiency, accuracy, and compliance in safety reporting. It directly contributes to improving patient safety outcomes by enabling faster signal detection, streamlined workflows, and high-quality regulatory submissions across global markets.

Job Description
The Safety & PV Technology Project Manager at Syneos Health is responsible for leading and executing technology-driven pharmacovigilance projects. The role focuses on implementing advanced solutions such as automation and AI to optimize safety operations. The candidate will manage end-to-end project delivery, coordinate cross-functional teams, and ensure alignment with regulatory and organizational standards.

Key Features of the Role:
• Ownership of end-to-end PV technology transformation projects
• Exposure to AI, automation, and touchless case processing systems
• Collaboration with global cross-functional teams including IT and safety operations
• Opportunity to work on advanced pharmacovigilance platforms like Argus
• High-impact role influencing operational efficiency and compliance

Responsibilities
• Lead and manage pharmacovigilance technology projects from initiation to closure
• Develop and maintain project plans, timelines, and resource allocation strategies
• Coordinate with IT, safety teams, STS, and external vendors for project execution
• Monitor milestones, deliverables, and proactively mitigate risks
• Ensure compliance with regulatory requirements and internal SOPs
• Represent the Technology Oversight Team in governance and safety forums
• Support implementation of AI and automation solutions in PV processes
• Drive change management initiatives and ensure user adoption of new systems
• Communicate project updates and performance metrics to stakeholders

Required Qualifications
• Strong understanding of pharmacovigilance and drug safety processes
• Proven experience in project management within a cross-functional environment
• Ability to manage complex timelines, stakeholders, and deliverables
• Familiarity with safety databases such as Argus Safety
• Strong communication, organizational, and problem-solving skills

Educational Requirements:
• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Healthcare, or related field

Experience and Skills:
• Minimum 5+ years of total experience
• 2–3 years of experience in pharmacovigilance or drug safety
• 2–3 years of experience in project management roles
• Experience managing cross-functional teams and large-scale projects
• Knowledge of global regulatory requirements and compliance standards
• Exposure to AI or automation-based initiatives is an added advantage
• Certification such as PMP or PRINCE2 is preferred

Salary Insights
• Estimated salary range: ₹12 LPA – ₹25 LPA depending on experience and expertise

Company Overview
Syneos Health is a leading fully integrated life sciences organization that supports pharmaceutical and biotechnology companies across the entire drug development lifecycle. With strong expertise in clinical research, regulatory services, and commercialization, the company works with global innovators to accelerate the delivery of therapies to patients. It offers a collaborative work culture, global exposure, and strong career development opportunities.

FAQs

• What is the main objective of this role?
The role focuses on managing pharmacovigilance technology projects and implementing automation to improve safety operations.

• Is pharmacovigilance experience mandatory?
Yes, prior experience in pharmacovigilance or drug safety is required.

• Are project management certifications necessary?
Not mandatory, but certifications like PMP or PRINCE2 are preferred.

• Does this role involve global collaboration?
Yes, it involves working with cross-functional and international teams.

• What tools are commonly used?
Tools like Argus Safety and project management platforms are commonly used.

Application Tips

• Highlight both pharmacovigilance and project management experience clearly in your resume
• Showcase experience with safety databases and regulatory compliance
• Emphasize involvement in automation, AI, or digital transformation projects
• Demonstrate stakeholder management and leadership skills with examples
• Tailor your CV to reflect measurable achievements in project delivery and process improvement