Associate Director – Safety & Pharmacovigilance | Hyderabad, India
Location: Hyderabad, India
Job Type: Full-Time
Job ID: 25103581
About Syneos Health
Syneos Health® is a global, fully integrated biopharmaceutical solutions organization that accelerates drug development by delivering clinical, medical affairs, and commercial solutions. With 29,000 employees across 110 countries, we bring patients and customers to the center of everything we do, driving efficiency, compliance, and innovation in clinical development.
Our culture emphasizes career development, mentorship, inclusion, and diversity, creating an environment where professionals can grow while contributing to life-changing therapies.
Role Overview
We are seeking an Associate Director – Safety & Pharmacovigilance to lead our Safety and PV function, providing strategic oversight, operational management, and regulatory compliance across global clinical programs. This senior leadership role ensures high-quality safety reporting, manages cross-functional teams, and drives improvements in pharmacovigilance processes.
The role is ideal for candidates with CRO experience, strong leadership skills, and expertise in clinical safety, regulatory requirements, and project management.
Key Responsibilities
Leadership & Team Management
Lead Safety and PV associates and managers, overseeing motivation, training, professional development, and performance appraisals.
Approve staffing, hiring, terminations, and mentoring plans to optimize team performance.
Monitor work quality, efficiency, and adherence to Safety Management Plans, providing corrective guidance as needed.
Operational Oversight & Project Management
Provide operational direction for Safety and PV projects, ensuring compliance with SOPs, Work Instructions (WIs), and global regulations.
Review project budgets, expenses, and resourcing needs; collaborate with Finance for invoicing and cost management.
Ensure timely submission of safety reports and documents, and act as escalation point for internal and sponsor-related issues.
Regulatory & Compliance Responsibilities
Maintain up-to-date knowledge of GCP, ICH, GVP, HIPAA, and global regulatory guidelines.
Participate in audits and inspections; ensure inspection readiness and implement corrective actions.
Review clinical safety sections of protocols, CRFs, and Serious Adverse Event forms for consistency.
Client Engagement & Business Development
Represent Safety & PV at project and client meetings; provide consultation and training on safety-related matters.
Support proposal development, bid defenses, and capability presentations to clients.
Collaborate with internal and external stakeholders to identify process improvements and enhance efficiency.
Required Qualifications & Experience
Education:
BA/BS in Biological Sciences, Nursing, Life Sciences, or equivalent combination of education and experience.
Experience:
Progressive leadership experience in Safety and Pharmacovigilance within a CRO or pharmaceutical setting.
Proven experience managing clinical safety teams and projects in accordance with regulatory standards.
Strong understanding of financial budgets, project costing, and resource management is preferred.
Skills & Competencies:
Excellent oral, written, and interpersonal communication skills.
Ability to manage multiple priorities, make effective decisions, and lead teams in a dynamic, matrix environment.
Proficiency in Microsoft Office Suite, Visio, TeamShare, and internet-based workflow tools.
Strong client relationship management and negotiation skills.
Why Join Syneos Health
Lead a high-impact Safety & PV function supporting global clinical programs.
Collaborate with cross-functional teams, sponsors, and global clients.
Access career development, mentorship, and leadership growth opportunities.
Work in a culture that values diversity, inclusion, and continuous improvement.
About Syneos Health
Over the past 5 years, Syneos Health has contributed to 94% of all novel FDA-approved drugs, 95% of EMA-authorized products, and managed 200+ clinical studies across 73,000 sites involving 675,000+ patients. We empower leaders to drive innovation, ensure compliance, and deliver life-changing therapies globally.
Apply Now
Advance your career as Associate Director – Safety & Pharmacovigilance and join a global leader in pharmacovigilance, clinical safety, and regulatory compliance.
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