Safety & PV Technology Project Manager

Why This Role Matters
The Safety & PV Technology Project Manager plays a crucial role in transforming pharmacovigilance operations by integrating advanced technologies such as AI and automation. This position directly contributes to improving drug safety processes, ensuring faster and more accurate safety reporting, and enhancing compliance with global regulatory requirements. By driving innovation in safety systems, the role supports better decision-making and ultimately helps protect patient health on a global scale.

Job Description
The role involves leading and managing pharmacovigilance technology projects that aim to optimize safety operations. The candidate will oversee project planning, execution, and delivery while coordinating with cross-functional teams including IT, safety operations, and external vendors. The position requires strong expertise in both pharmacovigilance and project management to ensure seamless implementation of technology-driven initiatives in drug safety.

Key Features of the Role:
• End-to-end ownership of PV technology projects from initiation to completion
• Exposure to AI, automation, and digital transformation in pharmacovigilance
• Cross-functional collaboration with global teams and stakeholders
• Opportunity to work on advanced safety systems like Argus and automation platforms
• High-impact role influencing operational efficiency and patient safety

Responsibilities
• Lead and manage pharmacovigilance technology projects across lifecycle phases
• Develop detailed project plans, timelines, and resource allocation strategies
• Coordinate with IT, PV teams, and external vendors for smooth execution
• Monitor project progress, track deliverables, and mitigate risks proactively
• Ensure compliance with regulatory requirements and internal SOPs
• Support implementation of AI and automation solutions in PV processes
• Drive change management and user adoption for new systems
• Communicate project updates and performance metrics to stakeholders
• Participate in governance meetings and represent the technology team

Required Qualifications
• Strong understanding of pharmacovigilance processes and drug safety systems
• Proven experience in project management within a cross-functional environment
• Ability to manage multiple stakeholders and complex project timelines
• Familiarity with safety databases such as Argus
• Excellent communication, leadership, 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 in managing timelines, resources, and stakeholder communication
• Knowledge of regulatory guidelines and compliance requirements
• Exposure to automation or AI-based projects is an added advantage
• Certification such as PMP or PRINCE2 is preferred but not mandatory

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

Company Overview
Syneos Health is a leading global clinical research and life sciences organization that supports drug development and commercialization. The company collaborates with pharmaceutical and biotech innovators to accelerate the delivery of therapies to patients. With a strong global presence and expertise in clinical, regulatory, and safety domains, Syneos Health offers a dynamic and growth-oriented work environment.

FAQs

• What is the main focus of this role?
The role focuses on managing pharmacovigilance technology projects and implementing automation in drug safety processes.

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

• Are certifications like PMP required?
Not mandatory, but preferred for project management roles.

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

• What tools are commonly used in this role?
Safety databases like Argus and various project management tools are commonly used.

Application Tips

• Highlight both pharmacovigilance and project management experience in your resume
• Showcase experience with safety databases and regulatory compliance
• Emphasize any exposure to automation, AI, or digital transformation projects
• Prepare examples demonstrating stakeholder management and problem-solving skills
• Tailor your CV to reflect achievements in managing complex projects and delivering results