Director, Safety and PV

Job Description

*Director, Safety & Pharmacovigilance Come discover what our 25,000+ employees already know: work here matters everywhere. We re a growing and evolving biopharmaceutical industry leader, which means you ll have endless opportunities to work with experts around the world and build the career you ve dreamed of. As a part of the Syneos Health team, you ll help us deliver results for a rewarding reason we improve patients lives around the world. Because to us, a patient isn t just a number, they re our family, friends, and neighbors.Why Syneos Health #SyneosHealthLife means we re committed to our Total Self culture where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person s unique contributions make a difference. We believe our success is a direct result of the people who are driving it you We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives we re able to create a place where everyone feels like they belong.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 operational and strategic leadership for Safety and Pharmacovigilance to achieve the Company s mission, creating value for customers. Evaluates and measures performance metrics and improves processes, as needed. 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 ensure 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., *What we re looking for

• 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.
• 12-15 Years of working experience in PV Case Processing department
• 3+ years of experience in Managing more than 100 + ICSR Case processing team members
• Strong working experience on Project Delivery, Operations, KPI, Finance, Stakeholder Management related activities
• 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, PowerPoint, MS Project), email, 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.

Get to know Syneos Health We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.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.

Keyskills :
americans with disabilities actmicrosoft officeleadership skillscase processingdrug developmentaudio masteringwork instructionsstandard operating proceduresline managementproject deliverystatements of work sow