Safety & PV Proj Delivery Lead

Safety & PV Proj Delivery Lead

inVentiv Health Clinical SRE, LLC
Not Specified
Not Specified

Job Description

Job Description :
Safety Project Delivery Lead, 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
. 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. Qualifications
What we're looking for
. 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.
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.
As a healthcare company we have an important responsibility to protect individual and public health. This position will require individuals to be fully vaccinated against COVID-19 as part of their job responsibilities, unless an exemption can be confirmed based on a medical condition or sincerely held religious belief. Submission & Approval of an Exemption does not guarantee that an exemption can be accommodated.
This job excludes CO applicants.

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