Job Title
Manager, Safety & Pharmacovigilance (ICSR)
Company
Syneos Health®
Location: Hyderabad, India (Hybrid Work Model)
Job ID: 25100465
Updated: August 14, 2025
About Syneos Health
Syneos Health is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success by delivering innovative clinical, medical affairs, and commercial solutions. With a workforce of 29,000 employees across 110 countries, Syneos Health fosters a culture of collaboration, agility, and inclusion.
Position Summary
The Manager, Safety & Pharmacovigilance (ICSR) is responsible for leading and managing the Safety & Pharmacovigilance team focused on Individual Case Safety Report (ICSR) processing. This role includes line management, project oversight, process improvement, compliance, budget management, and cross-functional coordination.
Key Responsibilities
People Management
Manage and lead Safety & Pharmacovigilance team members including hiring, transfers, performance appraisals, training, and counseling.
Approve time sheets and manage employee utilization.
Provide guidance on administrative policies, technical issues, and prioritization.
Mentor team members and support professional development.
Project & Quality Management
Assign and review project workloads and ensure adherence to Safety Management Plans.
Monitor quality and efficiency of team deliverables.
Manage Safety and Pharmacovigilance projects ensuring contractual and budget compliance.
Review study budgets, coordinate with Finance for invoicing, and approve project expenses and time cards.
Provide regular project updates to sponsors.
Coordinate cross-departmental safety reporting and issue resolution.
Departmental Leadership
Assist in developing, reviewing, and approving departmental SOPs.
Review and ensure execution of Safety Management and Reporting Plans.
Recommend and implement process improvements to enhance efficiency and effectiveness.
Collaborate with Business Development to support new business opportunities.
Represent Safety & Pharmacovigilance at project and client meetings.
Regulatory & Compliance
Review and approve safety sections in project proposals, protocols, and case report forms (CRFs).
Ensure compliance with SOPs, Work Instructions, GCP, ICH guidelines, GVP modules, and drug development processes.
Manage audit and inspection readiness and participate in investigations and CAPA implementation.
Training & Development
Identify training needs and deliver relevant safety training to team members and other departments.
Support mentoring and ongoing development of the Safety team.
Other
Manage resource needs and escalate issues to senior management as needed.
Perform other duties as assigned.
Minimal travel may be required.
Qualifications
Education
BA/BS in Biological Sciences, Natural Science, Healthcare field, Nursing, or equivalent combination of education and experience.
Experience
Minimum 8+ years in Pharmacovigilance.
At least 5 years of people management experience.
Technical Skills
Proficiency in MS Excel is essential.
Experience with ARGUS / ARISg Safety Databases preferred.
Knowledge of SQL and Power BI is a plus.
Experience in Clinical Research Organization (CRO) with therapeutic specialties preferred.
Understanding of financial budgets and analysis tools is beneficial.
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint), Visio, Outlook, TeamShare (or similar).
Soft Skills
Excellent oral, written, and interpersonal communication skills.
Strong graphic presentation skills.
Ability to build effective client and team relationships.
Flexibility and adaptability in a dynamic, matrixed work environment.
Strong decision-making and multitasking abilities.
Employment Details
Location: Hyderabad (Office-based, Hybrid work model)
Job Type: Full-time
Why Syneos Health?
Commitment to career development and progression.
Supportive management and inclusive culture promoting authenticity.
Collaborative, innovative, and global work environment.
Additional Information
Job duties may change at company discretion.
Equivalent experience and education may be considered.
The company complies with labor laws and promotes equal opportunity employment.
Reasonable accommodations are provided as per ADA guidelines.
Application
Interested candidates can apply directly or join the Syneos Health Talent Network for future opportunities.
Learn more: Syneos Health Website
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