Associate Director, Safety & PV
Syneos Health, Inc., Morrisville, NC, United States
Updated:
April 7, 2026 Location:
IND-Gurugram Job ID:
25104831
Job Responsibilities
Serve as interface between Company, sponsors, vendors, and other departments in the area of Safety and Pharmacovigilance.
Line management responsibilities for Safety and Pharmacovigilance associates and managers; approve courses of action on associate motivation, training, interviewing and selection, terminations, professional development, performance appraisals, and employee counseling.
Provide operational oversight of functional teams and projects.
Monitor quality of work and efficiency of team members with contracted scope of work and Safety Management Plan; discuss below‑target project goals with senior safety management.
Oversee projects where Safety and Pharmacovigilance are the primary services, including reviewing study budgets and expenses and ensuring all study‑related contractual and budgeting issues are upheld and performed.
Work with Finance to ensure appropriate customer invoicing where required and approve project time cards and invoicing.
Provide sponsors with scheduled project updates and reports and act as a point of escalation for sponsors.
Coordinate with other internal departments and Safety functional areas to ensure timely review and submission of reports and documents relating to safety reporting and resolution of issues.
Participate in the development, review, and approval of departmental Standard Operating Procedures (SOPs); review, provide input, and ensure the execution of the Safety Management Plan/Safety Reporting Plan.
Evaluate processes for potential improvement in efficiency and effectiveness and recommend changes; participate in process development and improvement of departmental functions and technology.
Work with Business Development to actively solicit new business, as needed.
Represent Safety and Pharmacovigilance at project team meetings and client meetings; review, advise, and approve Safety portions of proposals to ensure wording adequately reflects the scope of work for Safety and Pharmacovigilance.
Review clinical safety sections of study protocols and Case Report Forms (CRFs) to ensure consistency with the Serious Adverse Event form and approve budget projections for the project.
Oversee resourcing needs/issues for Safety services and escalating to senior management as necessary.
Interact with clients and internal staff to provide advice and guidance on safety review issues; provide training and consultation to clients.
Maintain understanding and ensure compliance of SOPs, Work Instructions, global drug/biologic/device regulations, Good Clinical Practices (GCPs), ICH guidelines, GVP modules and the drug development process.
Participate in audits/inspections and ensure inspection readiness; participate in quality investigations and implementation of corrective and preventive actions.
Perform other work‑related duties as assigned.
Moderate travel may be required.
Qualifications
BA/BS in the biological sciences or related disciplines in the natural science/health care field or nursing degree or equivalent combination of education and experience.
Progressive responsibility with demonstrated leadership skills and project management.
Clinical Research Organization (CRO) experience with therapeutic specialties preferred.
Working knowledge of financial budgets and various financial analysis tools preferred.
Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace), and internet.
Excellent oral, written, and interpersonal communication skills with strong graphic presentation skills.
Ability to establish effective relationships with clients as well as team members.
Ability to be flexible, adapt to change, work independently, as well as part of a team in a matrix environment.
Ability to make effective decisions and manage multiple priorities while delivering high quality work in a dynamic environment.
At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. We also encourage you to join our Talent Network to stay connected to additional career opportunities.
Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, please contact us at:
jobs@syneoshealth.com
#J-18808-Ljbffr
April 7, 2026 Location:
IND-Gurugram Job ID:
25104831
Job Responsibilities
Serve as interface between Company, sponsors, vendors, and other departments in the area of Safety and Pharmacovigilance.
Line management responsibilities for Safety and Pharmacovigilance associates and managers; approve courses of action on associate motivation, training, interviewing and selection, terminations, professional development, performance appraisals, and employee counseling.
Provide operational oversight of functional teams and projects.
Monitor quality of work and efficiency of team members with contracted scope of work and Safety Management Plan; discuss below‑target project goals with senior safety management.
Oversee projects where Safety and Pharmacovigilance are the primary services, including reviewing study budgets and expenses and ensuring all study‑related contractual and budgeting issues are upheld and performed.
Work with Finance to ensure appropriate customer invoicing where required and approve project time cards and invoicing.
Provide sponsors with scheduled project updates and reports and act as a point of escalation for sponsors.
Coordinate with other internal departments and Safety functional areas to ensure timely review and submission of reports and documents relating to safety reporting and resolution of issues.
Participate in the development, review, and approval of departmental Standard Operating Procedures (SOPs); review, provide input, and ensure the execution of the Safety Management Plan/Safety Reporting Plan.
Evaluate processes for potential improvement in efficiency and effectiveness and recommend changes; participate in process development and improvement of departmental functions and technology.
Work with Business Development to actively solicit new business, as needed.
Represent Safety and Pharmacovigilance at project team meetings and client meetings; review, advise, and approve Safety portions of proposals to ensure wording adequately reflects the scope of work for Safety and Pharmacovigilance.
Review clinical safety sections of study protocols and Case Report Forms (CRFs) to ensure consistency with the Serious Adverse Event form and approve budget projections for the project.
Oversee resourcing needs/issues for Safety services and escalating to senior management as necessary.
Interact with clients and internal staff to provide advice and guidance on safety review issues; provide training and consultation to clients.
Maintain understanding and ensure compliance of SOPs, Work Instructions, global drug/biologic/device regulations, Good Clinical Practices (GCPs), ICH guidelines, GVP modules and the drug development process.
Participate in audits/inspections and ensure inspection readiness; participate in quality investigations and implementation of corrective and preventive actions.
Perform other work‑related duties as assigned.
Moderate travel may be required.
Qualifications
BA/BS in the biological sciences or related disciplines in the natural science/health care field or nursing degree or equivalent combination of education and experience.
Progressive responsibility with demonstrated leadership skills and project management.
Clinical Research Organization (CRO) experience with therapeutic specialties preferred.
Working knowledge of financial budgets and various financial analysis tools preferred.
Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace), and internet.
Excellent oral, written, and interpersonal communication skills with strong graphic presentation skills.
Ability to establish effective relationships with clients as well as team members.
Ability to be flexible, adapt to change, work independently, as well as part of a team in a matrix environment.
Ability to make effective decisions and manage multiple priorities while delivering high quality work in a dynamic environment.
At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. We also encourage you to join our Talent Network to stay connected to additional career opportunities.
Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, please contact us at:
jobs@syneoshealth.com
#J-18808-Ljbffr