Description

Safety and PV Project Delivery Lead ** HYBRID Serbia **

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

Job Summary;

Responsible and accountable for the customer-focused leadership and management of Safety and Pharmacovigilance (SPVG) deliverables within the assigned projects or programs. Directs the technical and operational aspects of the SPVG deliverables of the assigned projects. Accountable for the delivery of all contracted safety activities on time, on budget, and in compliance with all applicable regulations. Responsible for overseeing all SPVG activities from start-up through to maintenance and closure. Develops integrated SPVG project/program delivery timelines and reports weekly progress including plans to address potential risks/gaps to the project team, Project Manager (PM) (if applicable), SPVG Management and Project/Program Sponsor/Customer.

Core Responsibilities;

Collaborates with Sponsor/Customer and major functional area leads (e.g. Project Management, Clinical Monitoring, SSU, Medical Writing, Data Management etc.) as the key liaison between the client and Syneos Health SPVG.
Ensures all project deliverables meet the internal and external customers’ expectations as per contracted deliverables, providing accurate projections, reports and updates, and ongoing risk assessments.
Develops and maintains relationships with customers in alignment with their assigned projects. May collaborate with business leads for business development, alliance management, contracts and proposals development, project management, and clinical management to achieve project goals. Ensures that individual project targets and client needs are met, services are provided with the highest quality standards, and policies and procedures are followed. Contributes to change initiatives across and within the SPVG department.
Provides oversight of all project SPVG deliverables which encompasses all activities throughout the duration of the project/program.
Assumes accountability on SPVG deliverables including, but not limited to:
Start-up safety activities (Kick-Off Meeting (KOM), Quick Start Camp (QSC));
Day to day operational management and execution of all project deliverables
Financial performance and budget. Responsible for ensuring that SPVG services are within scope of work and escalating/raising Change Orders when necessary
Develop detailed project/program specific Safety Management Plans and other project plans as applicable (e.g. communication plan, quality plan)
Ensures adherence to and monitors project/program-specific key performance indicators (KPIs)
Adequate project/program resourcing including annual leave and public holiday coverage
Develops plans in accordance with Standard Operating Procedures and/or client-scoped process. Complies with all controlled document requirements and other requirements to ensure quality deliverables.
Develops and manages integrated SPVG project/program delivery timelines and reports weekly progress including plans to address potential timing risks/gaps.
Prepares and presents overall SPVG strategy and status at client meetings and communicates outcomes to project team.
Reviews the project SPVG budget with the functional leads, project PM, and the SPVG Business Unit Controller against project milestones and budget to ensure project profitability. Takes corrective measures where necessary to keep project in line with budget and gross profit expectations.
Accountable for ensuring that backlog for assigned projects is reviewed monthly and is an accurate reflection of work to be completed
Uses professionally recognized tools for planning and management of scope, timeline, resources, and ensures that minimum hours are used for tasks. If out-of-scope work is requested, notifies the project PM and her/his SPVG manager and track out of scope until assigned to back log.
Identifies best practices and participates in process improvement initiatives in conjunction with the global SPVG leadership plan and project deliverables.
Train/mentor key SPVG project team members on project/program specific tasks and a working knowledge of the project/program assigned
Participates in audits/inspections and ensures inspection readiness at all times. Participates in quality investigations and implementation of corrective and preventative actions.
Participates in new business development activities including participation at client presentations. Provides information to support business development activities.
Maintains understanding of and ensures compliance of SOPs, WIs, global drug/biologic/device regulations, GCP, ICH guidelines, Good Pharmacovigilance Practice (GVP) modules, study/program plans and the drug development process.

Other Responsibilities:

Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements (clinical studies/programs only) or the Pharmacovigilance System Master File (PSMF) for post-marketing programs.
Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).

Qualifications;

Bachelor’s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.

Minimum five (5) years SPVG experience required preferably in a CRO industry.
Safety database systems experience and knowledge of medical terminology required.
Experience with leading/co-leading at least five (5) studies/programs from award and into maintenance; at least two (2) of those studies/programs must have included multiple regions and/or multiple products.
Excellent understanding of the clinical trial process across Phases I-IV and/or post-marketing safety requirements, ICH GCP and regulations related to Safety and Pharmacovigilance.
Good understanding of clinical protocols and associated study specifications.
Project management experience in a fast-paced environment.
Strong organizational skills with proven ability to handle multiple tasks.
Excellent communication, presentation and interpersonal skills.
Quality-driven in all managed activities.
Strong negotiating skills.
Strong problem-solving skills.
Demonstrate an ability to provide quality feedback and guidance to peers.
Contribute to a training plan within SPVG and update SOPs/WI.
Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace) and internet.

Disclaimer;

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.

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

Safety and PV Project Delivery Lead HYBRID Serbia

Description

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