Manager, Safety & Pharmacovigilance (ICSR) – Hyderabad, India
Location: Hyderabad, India
Job Type: Full-Time
Job ID: 25103579
Updated: December 29, 2025
About Syneos Health
Syneos Health is a leading global biopharmaceutical solutions organization, committed to accelerating customer success by translating clinical, medical affairs, and commercial insights into actionable outcomes. Our integrated approach enables faster development and delivery of therapies that improve patient lives.
With over 29,000 employees across 110 countries, Syneos Health fosters a collaborative, inclusive, and high-performance culture where every role contributes to shortening the distance from lab to life®.
Position Overview
We are seeking a Manager, Safety & Pharmacovigilance (ICSR) to lead a high-performing pharmacovigilance team, ensuring timely and compliant management of individual case safety reports (ICSRs) across clinical trials and post-marketing programs. This role combines people management, project oversight, regulatory compliance, and strategic leadership.
The Manager is responsible for maintaining quality, driving process improvements, and ensuring the team delivers on safety and pharmacovigilance commitments to internal and external stakeholders.
Key Responsibilities
Team Leadership & Management:
Manage direct reports including hiring, training, professional development, performance appraisals, time sheet approvals, and employee counseling.
Assign projects, review workloads, and provide guidance aligned with organizational goals.
Mentor team members and provide necessary training in Safety & PV practices.
Project & Safety Management:
Oversee projects where Safety and PV are primary services, including clinical trial safety reporting.
Review study budgets, invoices, and resource allocation; ensure financial compliance and client billing accuracy.
Provide regular project updates and reports to sponsors and stakeholders.
Coordinate with internal departments to ensure timely submission and review of safety reports.
Review protocols, CRFs, and project proposals for accuracy and alignment with safety requirements.
Process Improvement & Compliance:
Develop, review, and implement departmental SOPs and Safety Management Plans.
Monitor team performance against Safety Management Plan and contracted scope of work.
Participate in audits, inspections, and quality investigations; ensure inspection readiness.
Recommend process improvements for efficiency and compliance with regulatory requirements (GCP, ICH, GVP).
Stakeholder Engagement & Business Development:
Represent Safety & PV in client and internal meetings.
Collaborate with Business Development to identify and support new business opportunities.
Maintain strong working relationships with clients and project teams.
Required Qualifications
Education & Experience:
Minimum 8+ years in Pharmacovigilance, with at least 5 years in people management.
Bachelor’s degree in Biological Sciences, Nursing, Pharmacy, or related discipline; equivalent combination of education and experience considered.
Clinical Research Organization (CRO) experience preferred.
Technical Skills:
Strong expertise in ICSR processing, safety reporting, and regulatory compliance.
Hands-on experience with ARGUS or ARISg Safety Databases preferred.
Knowledge of SQL and Power BI is a plus.
Advanced proficiency in Microsoft Office Suite (Excel, Word, PowerPoint), Visio, Outlook, TeamShare, and internet tools.
Leadership & Communication:
Demonstrated leadership skills with ability to manage multiple projects and priorities.
Excellent oral, written, and interpersonal communication skills; strong presentation abilities.
Ability to establish effective relationships with clients, cross-functional teams, and direct reports.
Flexible, adaptable, and capable of working independently and in matrix environments.
Why Join Syneos Health
Lead a dynamic Safety & Pharmacovigilance team in a global, high-growth environment.
Play a critical role in ensuring patient safety and regulatory compliance.
Gain exposure to clinical programs, ICSR management, and GxP-compliant processes.
Contribute to innovative solutions that accelerate drug development and patient impact.
Additional Information
Tasks and responsibilities may evolve based on business needs. Syneos Health provides equal employment opportunities and reasonable accommodations to support employee success.
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