Director, Safety & PV (Veeva Safety Implementation & Operations)

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.
 
Discover what your 25,000 future colleagues already know:
 
Why Syneos Health
• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 

Job Responsibilities

• Oversees financial performance of assigned units; develops and manages top and bottom line revenue growth and expense budgets for Safety and Pharmacovigilance.
• Provides Veeva Safety Database expertise and leverages past experience with implementation and operational oversight of the Veeva Safety Database to benefit customers
• Provides operational and strategic leadership for Safety and Pharmacovigilance to achieve the Company’s mission, creating value for customers.
• Evaluates and measures performance metrics and leads business process excellence and business process optimization initiatives
• Directs the Safety and Pharmacovigilance associates to achieve on-time quality customer deliverables, contractual project requirements, utilization goals, and profitable results.
• Identifies and develops associates to carry out required functions. Provides professional development and growth opportunities as appropriate. Is accountable for appropriate escalation and resolution of issues within the department/business unit.
• Supports business development on project proposals and approval of Safety and Pharmacovigilance budgets.
• Assists in the creation, development and nurturing of key strategic customer relationships; develops strong relationships with current and prospective customers to generate new and/or add-on business. 
• Effectively leads and encourages collaboration and work sharing between offices to create a unified global Safety and Pharmacovigilance team.
•  Ensures best practices and processes are followed globally.
• Maintains current professional knowledge and expertise in fields of Safety and Pharmacovigilance to serve as a basis for providing “value added” expanded company services to all appropriate customers.
• Line management responsibilities for associates. Approves course of action on salary administration, interviews, hiring, terminations, professional development, performance appraisals, job descriptions and training.
• Implements quantifiable performance standards to facilitate improvement of global efficiencies and operational excellence.
• Participates in the development, review, and approval of departmental Standard Operating Procedures (SOPs).
• Evaluates processes for potential improvement in efficiency and effectiveness and recommends changes.
• Participates, defines, and approves process development and improvement of departmental functions and technology.
• Represents Safety and Pharmacovigilance, or ensures Safety representation, at project team meetings and client meetings.
• Provides oversight and governance between Company, sponsors, vendors, and other departments in the area of Safety and Pharmacovigilance.
• Maintains understanding and ensures compliance with Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, Good Clinical Practices (GCPs), ICH guidelines, Good Pharmacovigilance Practice (GVP) modules, study plans and the drug development process.
• Participates in audits/inspections and ensures inspection readiness. 
• Participates in quality investigations and ensures implementation of corrective and preventive actions.
• Performs other work related duties as assigned.
• Moderate travel may be required.
• Oversees financial performance of assigned units; develops and manages top and bottom line revenue growth and expense budgets for Safety and Pharmacovigilance.
• Provides Veeva Safety Database expertise and leverages past experience with implementation and operational oversight of the Veeva Safety Database to benefit customers
• Provides operational and strategic leadership for Safety and Pharmacovigilance to achieve the Company’s mission, creating value for customers.
• Evaluates and measures performance metrics and leads business process excellence and business process optimization initiatives
• Directs the Safety and Pharmacovigilance associates to achieve on-time quality customer deliverables, contractual project requirements, utilization goals, and profitable results.
• Identifies and develops associates to carry out required functions. Provides professional development and growth opportunities as appropriate. Is accountable for appropriate escalation and resolution of issues within the department/business unit.
• Supports business development on project proposals and approval of Safety and Pharmacovigilance budgets.
• Assists in the creation, development and nurturing of key strategic customer relationships; develops strong relationships with current and prospective customers to generate new and/or add-on business. 
• Effectively leads and encourages collaboration and work sharing between offices to create a unified global Safety and Pharmacovigilance team.
•  Ensures best practices and processes are followed globally.
• Maintains current professional knowledge and expertise in fields of Safety and Pharmacovigilance to serve as a basis for providing “value added” expanded company services to all appropriate customers.
• Line management responsibilities for associates. Approves course of action on salary administration, interviews, hiring, terminations, professional development, performance appraisals, job descriptions and training.
• Implements quantifiable performance standards to facilitate improvement of global efficiencies and operational excellence.
• Participates in the development, review, and approval of departmental Standard Operating Procedures (SOPs).
• Evaluates processes for potential improvement in efficiency and effectiveness and recommends changes.
• Participates, defines, and approves process development and improvement of departmental functions and technology.
• Represents Safety and Pharmacovigilance, or ensures Safety representation, at project team meetings and client meetings.
• Provides oversight and governance between Company, sponsors, vendors, and other departments in the area of Safety and Pharmacovigilance.
• Maintains understanding and ensures compliance with Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, Good Clinical Practices (GCPs), ICH guidelines, Good Pharmacovigilance Practice (GVP) modules, study plans and the drug development process.
• Participates in audits/inspections and ensures inspection readiness. 
• Participates in quality investigations and ensures implementation of corrective and preventive actions.
• Performs other work related duties as assigned.
• Moderate travel may be required.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.