Safety & PV Ops Specialist I

Description
Safety & PV Ops Specialist I

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

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 accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE
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 our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• 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
General

• Develops and maintains a repository of all relevant documents (e.g., Training, Safety and Pharmacovigilance Project Finance, Proposals tracking (awards and losses), RFI Library, departmental metrics, lists of audits/inspections).
• Develops and maintains Job Aids and process documents and maintains supporting documentation for these documents as needed.
• Maintains knowledge of all applicable FDA/EU/ICH guidelines and regulations relating to safety and PV reporting.
• Facilitates SPVG Annual Revenue targets by working with the operational SPVG team members and Therapeutic BU PMs / Project Directors, to ensure accurate and timely recognition of the BU in RBB.
• Provides SPVG metrics as appropriate at agreed upon intervals based on assigned tasks.
• Performs other work-related duties as assigned.
• Minimal travel may be required (up to 15%)

Quality & Compliance

• Facilitates the activities of Quality Planning by providing controlled document support per development, revision, or review; provides support for development of department or client-specific documents; track and communicate quality metrics to assess, evaluate, and facilitate team/individual achievement to the expected level of quality.
• Facilitates the activities of Quality Compliance verification and performance of quality control activities.
• Facilitates the activities of Quality Assurance by identifying and communicating areas of risk through risk-based process assessments;
• Provides expertise for procedures and QI support. May liaise with management and internal Corporate Quality Assurance (CQA) to monitor and ultimately bring to resolution any open QIs.
• Supports the safety project teams in maintaining audit and inspection readiness.

Training

• Plans, develops, creates, tracks, and presents the training materials (planned or ad hoc) for the Safety and Pharmacovigilance BU. Liaises with Safety and Pharmacovigilance leadership to identify appropriate content for inclusion of new or updated training materials (e.g. Safety Specialist, Safety Coordinator training, revenue recognition, and forecasting training).
• Provides Learning Management System (LMS) oversight for Safety and Pharmacovigilance.
• Develop PV specific training for inclusion in an accreditation program.

Technology

• Participates in audits and performs system demos when necessary.
• Participates in the Safety implementation/validation of Safety Systems projects (including creating, performing, and documenting), testing and documentation.
• Participates in the development and maintenance of departmental Standard Operating Procedures (SOPs) and Work Instructions (WIs) related to Safety Systems.
• Comprehensive understanding of IT SOPs and WIs that impact the business processes associated with Safety Systems.
• Analyzes and assists with programs for internal and external regulatory or customer report needs from Safety Systems
• Implements department efficiencies l related to Safety and Pharmacovigilance processes.
• Configures, administers, and maintains the Argus Safety database on a per project basis to ensure sponsor specific requirements are met.
• Participates in the development, validation/ testing, and maintenance of all Safety reporting tools (e.g. Business Objects)
• Creates and maintains Argus Project Information, Argus Product/Licenses, Argus User Access, and Report Request forms.
• Troubleshoots all issues regarding Argus and other Safety systems
• Assists with the development of Safety Systems and Argus-related training materials for End Users, and functional area trainers.
• Trains and mentors junior Safety Application Specialists
• Performs other tasks related to Safety Systems as necessary.
• Advises and assists Safety users with the use of alternate sponsor databases (such as ArisG, Clintrace, Sponsor Argus systems).
• Maintains understanding and ensure compliance with SOPs, WIs, global drug/biologic/device regulations, GCP, ICH guidelines, and the drug development process.
• Participates in the planning, writing, and execution of Safety System Data Migrations and custom reports
• Generate and perform quality check of listings, reports and queries from the safety database for internal, client, or regulatory use
• Assist in representation of Safety Applications team at project team and client meetings
• Maintain a high level of expertise regarding Safety & PvG systems and applications through participation in internal meetings and professional seminars and workshops

Proposals

• Facilitates SPVG Annual Gross Profit percentage (GP%) targets by working with the operational SPVG team members to ensure an appropriate understanding of the factors that drive GP% for the SPVG units in RBB.
• Attends Plan Activation Strategy calls and develops Safety and PVG proposal strategy by liaising with SPVG leadership.
• Ensures SPVG budget, text, and scope of work for responses to RFPs (Request for Proposals) and RFIs (Request for Information) are accurate and appropriate by working with appropriate SPVG and corporate partners. Solicits input from SPVG team members and other sources to develop the proposal. Liaises with SPVG leadership to identify appropriate named teams for inclusion in proposals.
• Assists with changes in scope and budget for SPVG by liaising with the Contracts team as well as Therapeutic BU Project Managers (PMs) and CDS/Safety Project Managers.
• Develops and maintains template proposal text and SPVG slides with periodic reviewing and updating of SPVG elements.
• Assists in the maintenance and updating of the SPVG elements of the costing model including reviewing project budget information on an ongoing basis to ensure hours and tasks in the cost model are realistic when compared with actual project SPVG financial information.
• Attends meetings such as bid defense meetings (in relation to SPVG proposal sections) and/or Project Hand-Over meetings as needed.

What We're Looking For

• Bachelor's degree in life science, registered nurse, pharmacist, computer science or technology related field (technical role) or equivalent combination of education and experience.
• Safety Database systems and moderate medical terminology required
• Extensive clinical research work, data collection/computer systems or equivalent experience including understanding and application of principles, concepts, practices, and standards in the pharmaceutical or CRO industry preferred (technical role)
• Excellent computer skills and knowledge of relational databases. Oracle Insight/Analytics/Data Mart, and Crystal Reports/Business Objects, SQL Plus experience preferred (technical role)
• Excellent knowledge of ICH guidelines and regulations relating to safety and pharmacovigilance.
• Proficiency in Microsoft Office Suite (Word, Excel, Visio, and PowerPoint), email (Outlook), and internet.
• Ability to work independently and in a team environment
• Ability to successfully prioritize and work on multiple tasks and projects
• Excellent communication, presentation, interpersonal skills, both written and spoken
• Strong organizational and documentation skills
• Detail oriented with a high degree of accuracy and ability to meet deadlines
• Able to make effective decisions
• Manage multiple priorities
• Minimal 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.

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.

Summary
Assists in providing operational support in multiple areas within the Safety & Pharmacovigilance Business Unit (BU). Assist the Safety Project delivery leads as required in their tasks, managing trainings, documents filing and updates, systems set up and access requests. Assist with department level tasks, process improvement initiatives and tools development as required.