Safety and PV Ops Specialist II

Syneos Health

Safety and PV Ops Specialist II at Syneos Health managing safety data and compliance documentation. Collaborating with teams to ensure regulatory adherence and project support for pharmacovigilance operations.

Posted 4/30/2026full-timeRemote • 🇺🇸 United StatesMid-LevelSeniorWebsite

About the role

Key responsibilities & impact

Maintains repository of all relevant documents (e.g. Training, Safety & Pharmacovigilance Project Finance, Proposals tracking [awards and losses], RFI Library, departmental metrics, and lists of audits/inspections).
Develops and maintains Job Aids and process documents and maintains supporting documentation for these documents as needed.
Ensures compliance to Standard Operating Procedures (SOP), Policies and SMP documents
Maintains knowledge of all applicable FDA/EU/ICH guidelines and regulations relating to safety and PV reporting.
Supports annual revenue targets by working with the operational team members and Therapeutic BU Project Managers / Project Directors to ensure accurate and timely recognition of the BU in RBB.
Provides support with the preparation of information for the Executive Project Reviews and the monthly Safety & Pharmacovigilance finance meeting.
Provides metrics as appropriate at agreed upon intervals based on assigned tasks.
Performs other work-related duties as assigned.
Supports 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.
Supports the activities of Quality Compliance verification of performance of quality control activities.

Requirements

What you’ll need

Atleast 3 plus years of PV experience
Strong expertise in technical writing for PV Department
Excellent written and verbal communication skills
Candidates with hands on experience with PDFs, Powerpoint and other office apps will be preferred.

Benefits

Comp & perks

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 building an inclusive culture – where you can authentically be yourself.

ATS Keywords

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Hard Skills & Tools

technical writingdocument managementmetrics trackingquality controlcompliance verificationprocess documentationSOP compliancesafety reportingpharmacovigilanceproject finance

Soft Skills

communicationorganizational skillsteam collaborationattention to detailproblem-solving