Associate Director – Safety & Pharmacovigilance (PV)
Job Requisition ID: 25103581
Employment Type: Full-Time
Work Mode: Office-Based
Location: Hyderabad, India
Experience Required: 10–14 Years
Function: Drug Safety | Pharmacovigilance | Clinical Research | Risk Management
About the Company
Syneos Health® is a global, fully integrated biopharmaceutical solutions organization supporting clinical development, medical affairs, and commercial operations. With a workforce of over 29,000 professionals across 110 countries, Syneos Health partners with leading pharmaceutical, biotechnology, and medical device companies to accelerate the development and delivery of innovative therapies worldwide.
Role Overview
Syneos Health is seeking an experienced Associate Director – Safety and Pharmacovigilance to provide strategic, operational, and people leadership across global safety programs. This role serves as a key interface between sponsors, internal stakeholders, and external vendors, ensuring regulatory compliance, operational excellence, and high-quality safety deliverables throughout the drug development lifecycle.
The position is ideal for senior pharmacovigilance professionals with strong CRO experience, people management expertise, and a deep understanding of global safety regulations and GVP requirements.
Key Responsibilities
Leadership & Stakeholder Management
Act as the primary interface between Syneos Health, sponsors, vendors, and internal departments for Safety and Pharmacovigilance activities
Provide line management to Safety and PV associates and managers, including performance management, training, professional development, and resource planning
Serve as an escalation point for sponsors and ensure timely communication of project updates and risk mitigation plans
Operational & Project Oversight
Provide oversight for Safety and Pharmacovigilance projects where PV is the primary service area
Ensure execution of Safety Management Plans (SMPs) and Safety Reporting Plans in alignment with contractual scope
Monitor team performance, quality metrics, timelines, and productivity; address deviations proactively
Review study budgets, track expenses, approve timecards, and support sponsor invoicing in collaboration with Finance
Regulatory Compliance & Quality
Ensure compliance with global regulations including ICH, GCP, GVP modules, and regional regulatory requirements
Oversee timely review and submission of safety reports, narratives, and regulatory documents
Participate in audits, inspections, CAPA management, and inspection readiness activities
Maintain and contribute to the development, review, and approval of departmental SOPs and Work Instructions
Business Development & Scientific Contribution
Support Business Development activities including proposal development, budget reviews, bid defenses, and scope definition for Safety and PV services
Review and approve safety sections of clinical study protocols, CRFs, and SAE forms
Provide expert guidance and training to clients and internal teams on safety-related matters
Education & Experience Requirements
Education:
Bachelor’s degree in Biological Sciences, Life Sciences, Pharmacy, Nursing, or a related healthcare discipline
Advanced degree is preferred but not mandatory
Experience:
10–14 years of progressive experience in Drug Safety and Pharmacovigilance
Minimum 5+ years in a leadership or people management role
Strong experience within a Clinical Research Organization (CRO) environment preferred
Demonstrated expertise in managing global safety projects and sponsor relationships
Key Skills & Competencies
In-depth knowledge of global pharmacovigilance regulations and drug development processes
Strong leadership, decision-making, and stakeholder management skills
Financial acumen including budget oversight and cost tracking
Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint), collaboration tools, and safety databases
Excellent written, verbal, and presentation skills
Ability to manage multiple priorities in a fast-paced, matrix environment
Why Join Syneos Health
Work on global, high-impact clinical development programs
Career progression through structured leadership and technical development
Inclusive, diverse, and people-focused work culture
Exposure to innovative safety technologies and global regulatory landscapes
Equal Opportunity Statement
Syneos Health is an equal opportunity employer and is committed to creating an inclusive and accessible workplace for all employees and applicants.
Apply now on thepharmadaily.com to advance your leadership career in Drug Safety and Pharmacovigilance with a global CRO.
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