Syneos Health - Germany

Sr Director, Safety & PV

Farnborough-1-Pinehurst, GBR;Europe - POL-Home-Based;Europe - PRT-Home-Based;Europe - ITA-Home-Based;Europe - GBR-Home-Based
09 Jun 2021
09 Jul 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Senior Director, Safety & Pharmacovigilance - EUROPE

Full time permanent role

Various levels can be considered (Sr. Director, Executive Director, VP)

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
• In conjunction with the VP and/or Executive Director, manages financial and operational performance of the Safety and Pharmacovigilance department/business unit. Ensures that financial and operational targets are achieved or exceeded. Responsible for functional leadership within Safety and Pharmacovigilance.
• Assists in the strategic and business goal planning within the department to enhance the financial and operational performance of the department/business unit including plans for expanding departmental revenue, margin, and resources where appropriate cost reduction solutions to improve profitability.
• Takes a leadership role within the Safety and Pharmacovigilance department in internal business unit initiatives.
• Provides operational and strategic leadership to the management teams and staff members and is accountable for appropriate escalation and resolution of issues within the department/business unit.
• Evaluates and measures performance metrics and improves processes, as needed.
• Ensures through Directors/Associate Directors that all aspects of the Company's Safety and Pharmacovigilance services are consistent with current industry standards/practices and meet all appropriate domestic and international regulatory requirements.
• Ensures customer focus is fostered throughout Safety and Pharmacovigilance department by opening and maintaining regular dialogues with key customers throughout the life of projects/programs where special focus on Safety and Pharmacovigilance is a priority.
• Promotes Safety and Pharmacovigilance function through appropriately channeled opportunities such as business unit leadership meetings, bid defense preparation meetings, company training forums and industry conferences.
• Provides strategic advice on project bids and budgets including the approval of proposal text and approval of Safety and Pharmacovigilance budgets.
• Ensures that the training provided within the department matches current provided services and is in accordance with local/global requirements and that when new services are introduced the training is in line with such requirements.
• Represents Safety and Pharmacovigilance as a senior leader/executive leader at joint/executive sponsor governance meetings.
• Oversees the creation, maintenance, and approval of the quality management system (SOPs/WIs etc.) within the Safety and Pharmacovigilance department.
• Facilitates the communication of key messages amongst all Safety and Pharmacovigilance staff either through all associates meetings or via management level meetings. Acts as a liaison and facilitator between other operational departments within the Company for safety and pharmacovigilance related issues.
• Provides governance and thought leadership 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 Practices (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.
• 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.

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.

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