Safety and PV Ops Specialist II

🕒 April 30

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

⚙️ Operations

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• 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

• 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

• 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.