Associate Director – Safety & Pharmacovigilance
Location: India – Hyderabad
Job Type: Full-Time
Job ID: 25103581
Updated: December 22, 2025
About Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization that accelerates customer success by translating clinical, medical affairs, and commercial insights into measurable outcomes. With 29,000 employees across 110 countries, we drive innovation in clinical development while fostering an inclusive, collaborative work environment.
Position Overview
The Associate Director – Safety & Pharmacovigilance leads the operational and strategic oversight of safety teams, ensuring high-quality pharmacovigilance services. This role involves managing Safety and PV associates, overseeing clinical trials and post-marketing safety programs, ensuring compliance with GCP, GVP, and regulatory standards, and acting as a primary interface between sponsors, vendors, and internal departments.
Key Responsibilities
Leadership & Team Management:
Line management for Safety and PV associates and managers, including recruitment, training, performance evaluations, and professional development.
Provide operational oversight of functional teams and projects, monitoring quality and efficiency against Safety Management Plans.
Oversee departmental processes, SOPs, and Safety Reporting Plans to ensure compliance and continuous improvement.
Project & Client Management:
Serve as primary safety point-of-contact for sponsors, vendors, and internal stakeholders.
Approve project budgets, timecards, and invoicing; coordinate with Finance for proper billing.
Represent Safety and PV in project meetings, proposal reviews, and bid defenses.
Oversee resourcing, escalations, and issue resolution within Safety services.
Compliance & Regulatory Oversight:
Ensure adherence to SOPs, WIs, GCP, ICH guidelines, GVP modules, and global drug/biologic/device regulations.
Review clinical safety sections of study protocols, CRFs, and safety reports.
Participate in audits, inspections, and quality investigations, implementing corrective and preventive actions as required.
Operational Excellence & Business Development:
Evaluate and improve departmental processes for efficiency and effectiveness.
Support Business Development activities, including proposal development and client consultations.
Maintain up-to-date knowledge of industry trends, regulatory changes, and best practices.
Required Qualifications
BA/BS in biological sciences, life sciences, nursing, or equivalent combination of education and experience.
Progressive leadership experience with project management in Safety & Pharmacovigilance.
CRO experience preferred, ideally with therapeutic specialization.
Strong financial acumen for project budgeting, analysis, and invoicing.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Visio, TeamShare, and other project management tools.
Excellent written, verbal, and interpersonal communication skills with strong presentation abilities.
Ability to manage multiple priorities, adapt to change, and work in a matrix environment.
Moderate travel may be required.
Why Join Syneos Health
Lead high-impact safety and pharmacovigilance programs across global clinical trials.
Collaborate with a diverse, inclusive, and highly skilled professional team.
Drive operational excellence while mentoring and developing Safety & PV teams.
Access career progression opportunities within a globally recognized CRO.
Gujarat :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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