Manager – Safety & Pharmacovigilance (ICSR) | Hyderabad, India
Location: Hyderabad, India
Employment Type: Full-Time, Permanent
Job ID: 25103579
About the Role
Syneos Health®, a global leader in integrated biopharmaceutical solutions, is seeking a Manager in Safety & Pharmacovigilance (ICSR) to lead and oversee ICSR operations for clinical trials and post-marketing safety programs.
This role is ideal for an experienced pharmacovigilance professional with proven leadership skills who is looking to manage a dynamic PV team within a fast-growing, global Clinical Research Organization (CRO). You will ensure compliance with global PV regulations, GVP, ICH-GCP guidelines, and lead your team in delivering high-quality safety case management and regulatory reporting.
Key Responsibilities
Team Leadership & Management
Lead, mentor, and manage a team of PV professionals, including hiring, training, performance appraisals, time-sheet approvals, and employee development.
Assign project work, monitor workload, and provide guidance on organizational goals and objectives.
Support team members in troubleshooting technical and operational issues.
Project & Safety Oversight
Manage safety and pharmacovigilance projects, ensuring adherence to the Safety Management Plan and regulatory compliance.
Review study budgets, track expenses, and coordinate with Finance for customer invoicing.
Approve project timecards and deliver regular project updates to sponsors.
Coordinate cross-functionally to ensure timely review and submission of safety reports and resolution of PV issues.
Process & Compliance Management
Develop, review, and implement departmental SOPs and Safety Reporting Plans.
Identify process improvement opportunities to enhance efficiency and effectiveness.
Represent PV in project and client meetings and ensure proper safety representation.
Review clinical safety sections of protocols, CRFs, and project proposals to ensure alignment with ICSR requirements.
Training & Audit Readiness
Deliver training to team members and other departments as needed.
Ensure inspection readiness, participate in audits, and implement corrective/preventive actions.
Maintain compliance with global drug/biologic/device regulations, SOPs, ICH-GCP, and GVP modules.
Other Responsibilities
Address resourcing needs and escalate issues to senior management.
Perform other duties as assigned with minimal travel as required.
Required Qualifications & Experience
Education:
BA/BS in Biological Sciences, Pharmacy, Nursing, or related life sciences discipline, or equivalent combination of education and experience.
Experience:
Minimum 8+ years of experience in pharmacovigilance.
5+ years of people management experience in a PV or drug safety environment.
Experience in Clinical Research Organization (CRO) settings preferred, especially in therapeutic specialties.
Exposure to ICSR management, PV processes, SOP compliance, and regulatory reporting.
Technical & Professional Skills:
Advanced proficiency in MS Excel and Microsoft Office Suite (Word, PowerPoint, Outlook).
Experience with ARGUS / ARISg Safety Databases preferred.
Knowledge of SQL / Power BI is an advantage.
Strong financial awareness including project budgets, forecasting, and invoicing.
Exceptional oral, written, and interpersonal communication skills, including presentation and reporting abilities.
Ability to build effective client and team relationships, work independently, adapt to change, and manage multiple priorities in a matrix environment.
Leadership & Project Management:
Demonstrated ability to manage teams, lead projects, and implement PV strategies.
Proven track record of mentoring and developing PV professionals.
Strong decision-making and problem-solving capabilities.
Why Join Syneos Health
Work with a global biopharmaceutical leader impacting patient safety across 110+ countries.
Lead and mentor a high-performing PV team while contributing to global drug safety initiatives.
Gain exposure to CRO operations, regulatory compliance, and cross-functional project management.
Competitive compensation and benefits with opportunities for career advancement.
Join a company that values diversity, inclusion, and employee development in a collaborative environment.
About Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization with 29,000 employees worldwide. We accelerate the delivery of therapies through innovative clinical, medical affairs, and commercial solutions. Our culture emphasizes collaboration, inclusivity, and innovation, providing a global platform for professional growth and impact.
Apply Now
Lead the future of Safety & Pharmacovigilance at Syneos Health in Hyderabad and drive high-quality ICSR operations while mentoring the next generation of PV professionals.
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