Job Title:
Manager, Safety & Pharmacovigilance (ICSR - Office Based)
Company:
Syneos Health
Location:
India-Asia Pacific - Pune, Panchshil-Avenue, India
Job ID:
25002242-IND746
Job Type:
Full-Time
Role Overview:
The Manager, Safety & Pharmacovigilance, will oversee line management responsibilities, including staffing, training, and project management. The role involves ensuring the quality of Safety and Pharmacovigilance services, managing budgets and contracts, coordinating internal teams, and ensuring compliance with regulatory standards. The position also includes mentoring team members, identifying areas for process improvement, and ensuring the timely review and submission of safety reports.
Key Responsibilities:
Line Management:
Manage staffing, performance appraisals, training, and counseling.
Assign project work and review workloads for direct reports.
Oversee team performance and quality of work.
Project Management:
Review budgets and ensure contractual and budgetary requirements are met.
Provide scheduled project updates and reports to sponsors.
Coordinate internal departments to ensure timely review and submission of safety-related documents.
Safety & Pharmacovigilance Oversight:
Assist in the development, review, and approval of departmental SOPs and safety management plans.
Represent Safety and Pharmacovigilance at client meetings and project team meetings.
Manage safety-related sections of project proposals and ensure accurate scope of work.
Compliance & Training:
Ensure compliance with global drug regulations, GCPs, and ICH guidelines.
Deliver training to safety team members and other departments.
Ensure the team is prepared for audits and inspections.
Leadership & Continuous Improvement:
Mentor and develop Safety team members.
Proactively identify areas for process improvement and recommend solutions.
Manage resources effectively, escalating issues as necessary.
Requirements:
Education:
BA/BS in biological sciences, healthcare field, or nursing, or an equivalent combination of education and experience.
Experience:
Progressive leadership experience in a clinical research organization (CRO).
Therapeutic specialties experience preferred.
Experience with financial budgets and financial analysis tools.
Skills:
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Visio, and other relevant tools.
Strong communication skills (oral, written, and interpersonal).
Ability to work independently and in a team-oriented matrix environment.
Flexibility and adaptability in a dynamic work environment.
Why Syneos Health?
Syneos Health focuses on career development and provides a supportive work environment.
The company promotes diversity and inclusion, ensuring every employee feels like they belong.
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