Sr Safety & PV Ops Specialist - ARGUS Administrator

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Sr Safety & PV Ops Specialist - ARGUS Administrator

Syneos Health

Home Based, Bulgaria

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.

Qualifications

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