Job Title:
Manager, Safety & Pharmacovigilance (JLPT)
Company:
Syneos Health
A global biopharmaceutical solutions organization that helps accelerate the delivery of therapies by providing integrated clinical, medical affairs, and commercial services.
Location:
Gurugram, Haryana, India (Asia Pacific - IND)
Job ID:
25002243
Updated:
April 27, 2025
Job Summary:
The Manager, Safety & Pharmacovigilance will lead safety and pharmacovigilance projects, supervise a team, and ensure compliance with safety management plans, reporting, and regulations. This role requires proficiency in Japanese (JLPT N3 or above) and is integral to ensuring safety within clinical trials by managing client relationships, reporting safety issues, and overseeing project budgets.
Key Responsibilities:
Line management of staff, including hiring, training, performance appraisals, time sheet approval, and counseling.
Assign project tasks and ensure the team meets organizational goals and client expectations.
Manage Safety and Pharmacovigilance services across projects, ensuring timely reporting and issue resolution.
Oversee project budgets, expenses, and invoicing, working closely with Finance.
Coordinate with other departments to ensure compliance with safety reporting and submission schedules.
Review, develop, and approve departmental SOPs and Safety Management Plans.
Assist in process improvements and business development activities.
Review safety sections of study protocols and ensure compliance with global regulations.
Train Safety team members and participate in audits/inspections to maintain inspection readiness.
Manage resource allocation and escalate issues to senior management when necessary.
Qualifications:
Must have:
JLPT N3 or above certification (Japanese language proficiency)
BA/BS in biological sciences, healthcare, or a related field (or equivalent experience)
Strong leadership and project management skills
Experience in Clinical Research Organizations (CROs) or related therapeutic specialties
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and other management tools
Excellent communication skills in both oral and written formats
Desired:
Knowledge of financial budgets and financial analysis tools
Experience working with safety and pharmacovigilance in clinical trials
Ability to adapt in a dynamic, matrixed environment and make effective decisions
Why Syneos Health?
Syneos Health brings together diverse perspectives and encourages employees to challenge the status quo to deliver life-changing therapies. The company provides opportunities for professional development, mentorship, and rewards for a job well done.
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