Job Description: Senior Safety & PV Operations Specialist
Company Overview: Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We harness unique clinical, medical affairs, and commercial insights to meet modern market challenges.
Our Clinical Development model centers on both the customer and the patient. We continually seek ways to simplify and enhance our processes to make Syneos Health easier to work with and for.
Joining us means collaborating with passionate problem solvers in either a Functional Service Provider or Full-Service environment, where innovation thrives as we work together to help our customers achieve their goals. We are agile and driven to expedite the delivery of therapies because we are committed to changing lives.
Why Syneos Health: We prioritize the development of our people through career growth, supportive management, training, peer recognition, and a robust total rewards program. Our Total Self culture fosters authenticity and inclusivity, ensuring everyone feels they belong.
Key Responsibilities:
General:
Develop and maintain a repository of key documents (e.g., Training, Safety and Pharmacovigilance Project Finance, Proposals tracking, departmental metrics).
Create and maintain Job Aids and process documents.
Stay updated on FDA/EU/ICH guidelines related to safety and PV reporting.
Collaborate with operational teams to meet SPVG Annual Revenue targets.
Provide relevant SPVG metrics at agreed intervals.
Perform other duties as assigned.
Occasional travel may be required (up to 15%).
Quality & Compliance:
Support Quality Planning by providing document control for development and revisions.
Monitor and verify quality compliance activities.
Identify and communicate risk areas through process assessments.
Provide expertise in quality improvement and liaise with Corporate Quality Assurance.
Ensure safety project teams are audit and inspection ready.
Training:
Design, create, and present training materials for the Safety and Pharmacovigilance BU.
Oversee Learning Management System (LMS) for Safety and Pharmacovigilance.
Develop PV-specific training for accreditation programs.
Technology:
Participate in audits and system demonstrations.
Support implementation and validation of Safety Systems projects.
Contribute to the development and maintenance of SOPs related to Safety Systems.
Configure and maintain the Argus Safety database to meet sponsor requirements.
Troubleshoot issues with Safety systems and assist in training materials development.
Mentor junior Safety Application Specialists.
Proposals:
Collaborate with operational teams to achieve SPVG Annual Gross Profit targets.
Develop Safety and PVG proposal strategies and ensure budget accuracy for RFPs and RFIs.
Maintain template proposal text and assist with cost model updates.
Attend relevant meetings such as bid defense and project handovers.
Qualifications:
Bachelor’s degree in life sciences, nursing, pharmacy, computer science, or a related field, or equivalent experience.
Familiarity with Safety Database systems and medical terminology.
Extensive experience in clinical research or data management in the pharmaceutical or CRO industry.
Proficiency in relational databases, with knowledge of Oracle Insight, Crystal Reports, and SQL Plus preferred.
Strong knowledge of ICH guidelines and safety regulations.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and email (Outlook).
Ability to work independently and in teams, manage multiple tasks, and prioritize effectively.
Excellent communication and organizational skills, with attention to detail.
Get to Know Syneos Health: In the past five years, we’ve collaborated on 94% of Novel FDA Approved Drugs and 95% of EMA Authorized Products, contributing to over 200 studies across 73,000 sites and 675,000+ trial patients.
At Syneos Health, you are empowered to challenge the status quo in a competitive and dynamic environment. Learn more about us.
Additional Information: The tasks and responsibilities in this job description are not exhaustive and may be modified at the company's discretion. Equivalent experience and qualifications may also be considered. This description does not create an employment contract and adheres to all legislative obligations, including compliance with the Americans with Disabilities Act.
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