Job Title
Manager, Safety & Pharmacovigilance (ICSR)
Company
Syneos Health®
Location: Gurugram, India (Hybrid Work Model)
Job ID: 25100465
Updated: August 14, 2025
About Syneos Health
Syneos Health is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success by leveraging clinical, medical affairs, and commercial insights. With 29,000 employees in over 110 countries, Syneos Health promotes a culture that centers on customers and patients and fosters collaboration, innovation, and inclusion.
Position Overview
The Manager, Safety & Pharmacovigilance (ICSR) will lead a team responsible for Individual Case Safety Report (ICSR) processing and overall pharmacovigilance activities. This role involves people management, project oversight, process improvement, regulatory compliance, and cross-functional coordination within Safety and Pharmacovigilance services.
Key Responsibilities
People Management
Oversee line management activities including hiring, transfers, terminations, training, professional development, performance appraisals, timesheet approval, and employee counseling.
Provide guidance on administrative policies, technical problems, and work prioritization.
Assign project work and review workloads for team members.
Mentor and develop Safety team members.
Project & Operational Management
Manage Safety & Pharmacovigilance projects, ensuring compliance with study budgets, contractual obligations, and Safety Management Plans.
Collaborate with Finance for customer invoicing and approve project timecards and invoices.
Provide scheduled project updates and reports to sponsors.
Coordinate with internal departments to ensure timely review and submission of safety reports and resolution of issues.
Departmental & Process Management
Assist in developing, reviewing, and approving departmental Standard Operating Procedures (SOPs).
Ensure execution of Safety Management and Reporting Plans.
Recommend and implement process improvements to enhance efficiency and effectiveness.
Support business development efforts to solicit new business.
Represent Safety and Pharmacovigilance at project team and client meetings.
Compliance & Quality
Review and approve Safety portions of project proposals, study protocols, and Case Report Forms (CRFs) for consistency with Serious Adverse Event (SAE) forms.
Maintain compliance with SOPs, Work Instructions, global drug/biologic/device regulations, GCPs, ICH guidelines, GVP modules, and drug development processes.
Participate in audits, inspections, quality investigations, and corrective/preventive action implementation.
Ensure inspection readiness of the Safety team.
Training & Development
Identify training needs and deliver necessary Safety training to team members and other Syneos Health departments.
Additional Responsibilities
Manage resource needs and escalate issues to senior management as required.
Perform other duties as assigned.
Minimal travel may be required.
Qualifications
Education
Bachelor’s degree (BA/BS) in Biological Sciences, Natural Sciences, Healthcare field, Nursing, or equivalent combination of education and experience.
Experience
Minimum 8+ years of experience in pharmacovigilance.
At least 5 years of experience in people management.
Skills & Knowledge
Strong proficiency in MS Excel.
Experience with ARGUS / ARISg Safety Databases preferred.
Knowledge of SQL and Power BI is advantageous.
Experience in Clinical Research Organization (CRO) and therapeutic specialties preferred.
Familiarity with financial budgeting and analysis tools preferred.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Visio, Outlook, TeamShare or equivalent.
Excellent oral, written, interpersonal, and graphic presentation skills.
Ability to build effective relationships with clients and team members.
Flexibility and adaptability in a dynamic matrix work environment.
Strong decision-making skills and ability to manage multiple priorities while maintaining quality.
Why Work at Syneos Health?
Commitment to career development and progression.
Supportive, inclusive culture emphasizing authenticity and belonging.
Opportunities to work in a global, collaborative environment that drives innovation and change.
Total rewards program and peer recognition initiatives.
Additional Information
Job duties and responsibilities may be updated at the company’s discretion.
Equivalent education and experience will be considered.
The company complies with all applicable labor laws, including equal employment opportunity and the Americans with Disabilities Act (ADA).
Reasonable accommodations will be provided when appropriate.
Application Process
Interested candidates are encouraged to apply or join the Syneos Health Talent Network to stay connected for future opportunities.
Learn more at: Syneos Health
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