Syneos Health hiring Principal Safety & PV Ops Spec – PV Quality Operation Lead

Principal Safety & PV Operations Specialist

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

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 Job Aids and process documents and maintains supporting documentation for these documents as needed.
• 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.
• Responsible for providing SPVG metrics as appropriate at agreed upon intervals based on assigned tasks.
• Provides mentoring and training on processing and reporting of safety procedures.
• Maintains knowledge of all applicable FDA/EU/ICH guidelines and regulations relating to safety and PV reporting.
• Provides oversight of activities and the quality and timely completion of deliverables.
• Performs other work-related duties as assigned.
• Minimal travel may be required (up to 20%)

Quality & Compliance

• Responsible for Quality Planning activities by providing controlled document support per development, revision, or review; provides support for development of department or client-specific documents; tracks and communicates quality metrics to assess, evaluate, and facilitate team/individual achievement to the expected level of quality.
• Responsible for Quality Assurance activities by identifying and communicating areas of risk through risk-based process assessments;
• Responsible for Quality Compliance verification and performance of quality control activities.
• 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.
• Responsible for Quality Improvement activities including the developing and promoting improvement initiatives; identifies and communicates deficiencies and/or deviations from company, department, or client processes; manages, tracks and/or assists with corrective and preventive action development and completion; participates in root cause analysis process.

Training

• Oversees the planning, development, creation and tracking of 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
• Oversee, review and approve the development of PV specific training for inclusion in an accreditation program

Technology

• Business Project Lead and liaison in projects associated with Argus
• May participate in the Oracle User Group, abiding by the Argus Safety Customer Global User Group Constitution
• Acts as key business liaison with Oracle for safety database related issues
• Provide project support related to Safety system issues and data outputs (e.g. aggregate report data) to Safety and Pharmacovigilance projects.
• Generate and perform quality check of listings, reports and queries from the safety database for internal, client, or regulatory use
• Work with BT/IT to ensure that Safety applications are maintained and operational per regulatory requirements and company processes
• Problem solving of issues related to the safety database and other safety required systems
• Review project specific Safety Management Plans regarding safety database and data outputs required
• Manage the Eudravigilance product registration process as required
• Maintain a high level of technical expertise regarding Safety systems and applications through participation in internal meetings and professional seminars and workshops
• Support signal detection activities through creation and generation of customized data outputs.
• Serve as technical SME during client meetings, audits and inspections. Performs system demos when necessary
• Participate in and contribute to Safety and Pharmacovigilance business development process as needed
• Leads in the Safety implementation/validation of Safety Systems projects (including creating, performing, and documenting), testing and required documentation
• Leads 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
• Leads the analysis and programming efforts for internal and external regulatory or customer report needs from Safety Systems
• Identifies initiates and leads the implementation of department efficiencies related to Safety and Pharmacovigilance processes
• Provides oversight and leadership for the configuration, administration, and maintenance of the Argus Safety database on a per project basis to ensure sponsor specific requirements are met
• Leads the development, validation/ testing, and maintenance of Safety reporting tools (e.g. Business Objects) for the Safety and Pharmacovigilance department.
• Troubleshoots issues regarding Argus and other Safety systems
• Oversees the development of Safety Systems and Argus-related training materials for Application Administrators and assists other functional area trainers as needed
• Performs other tasks related to Safety Systems as necessary
• Provides leadership support to Safety users with the use of alternate sponsor databases that the Company Safety group accesses (such as ARISg, Clintrace, Sponsor Argus systems)
• Maintains understanding and ensures compliance with SOPs, WIs, global drug/biologic/device regulations, GCP, ICH guidelines, Good Pharmacovigilance Practice (GVP) modules and the drug development process
• Leads the planning, writing, and execution of Safety System Data Migrations and custom reports

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 Safety Lead/Manager with changes in scope and budget for SPVG in liaising with the Contracts team as well as Therapeutic BU Project Managers (PMs) and CDS/Safety Project Managers.
• Responsible for ensuring the development and maintenance template proposal text and SPVG slides with periodic reviewing and updating of SPVG elements.
• Responsible for 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

• Should 5+ Years of experience in PV ICSR case processing
• Should 2+ Year of experience in Quality Related activities
• Having experience in CAPA writing/Audit is added advantage
• Should have worked on Project related QC activities
• ICSR case processing alone experience is not considered and Must have done QR related activities for more than 2 years at Project level
• Having experience in Quality database tools is preferred
• Should 5+ Years of experience in PV ICSR case processing
• Should 2+ Year of experience in Quality Related activities
• Having experience in CAPA writing/Audit is added advantage
• Should have worked on Project related QC activities
• ICSR case processing alone experience is not considered and Must have done QR related activities for more than 2 years at Project level
• Having experience in Quality database tools is preferred

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