Safety and PV Ops Specialist II

🕒 il y a 1 mois

🇺🇸 États-Unis – Télétravail

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

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Syneos Health

Site WebLinkedInTous les Emplois

10 000+ employés

🧬 Biotechnologie

💊 Pharmaceutique

⚕️ Assurance santé

Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health est une organisation de solutions biopharmaceutiques entièrement intégrée et leader, conçue pour accélérer le succès des clients. Ils transforment des intuitions cliniques, des affaires médicales et commerciales uniques en résultats pour répondre aux réalités du marché moderne. En utilisant des technologies avancées et des perspectives, Syneos Health collabore avec les clients pour accélérer la livraison de thérapies importantes aux patients dans le monde entier, offrant des services qui couvrent tout le spectre du clinique au commercial.

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.

🎯 Exigences

• 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.

🏖️ Avantages

• 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.