Safety and PV Ops Specialist II

🕒 Abril 30

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

⚙️ Operações

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Syneos Health

SiteLinkedInTodas as Vagas

10.000+ funcionários

🧬 Biotecnologia

💊 Farmacêutico

⚕️ Seguro de Saúde

Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health é uma organização líder, totalmente integrada, de soluções biofarmacêuticas, criada para acelerar o sucesso dos clientes. A empresa transforma insights exclusivos clínicos, de Assuntos Médicos (Medical Affairs) e comerciais em resultados para responder às realidades modernas do mercado. Ao utilizar tecnologias avançadas e insights, a Syneos Health colabora com os clientes para acelerar a entrega de terapias importantes a pacientes no mundo todo, oferecendo serviços que abrangem todo o espectro do clínico ao comercial.

Descrição

• 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.

🎯 Requisitos

• 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.

🏖️ Benefícios

• 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.