Marketed Prod Safety Spec 2

Job Description

Role Overview:You will be responsible for developing and preparing pharmacovigilance agreements for assigned customers. Additionally, you will prepare pharmacovigilance systems master files under direct supervision and act as the deputy EU-QPPV. Your essential functions will include working closely with project teams to determine appropriate terms and conditions of safety agreements, preparing and maintaining PSMFs, and reviewing PSMFs prepared by other specialists. As the primary customer interface on large complex projects, you will be responsible for developing and maintaining customer relationships, providing input to project plans, overseeing finalization and distribution of safety agreements, and assisting in the negotiation of safety agreement text using approved processes and templates. You will also represent the safety agreements team at customer meetings as required, provide input into project budgets involving safety agreements, offer advice, support, and guidance to other staff involved in preparing safety agreements, mentor and train team members, and perform all other duties as assigned.Key Responsibilities:- Develop and prepare pharmacovigilance agreements for assigned customers- Prepare and maintain PSMFs- Review PSMFs prepared by other specialists- Work closely with project teams to determine appropriate terms and conditions of safety agreements- Provide input to project plans to accurately reflect services provided- Oversee finalization and distribution of safety agreements- Assist in the negotiation of safety agreement text using approved processes and templates- Represent safety agreements team at customer meetings as required- Provide input into project budgets involving safety agreements- Offer advice, support, and guidance to other staff involved in preparing safety agreements- Mentor and train team membersQualifications:- Bachelors Degree, preferably in health science or related area- Minimum of 3 years of experience in Lifecycle Safety Pharmacovigilance, CEVA Medical Information safety Publishing, Risk Management, etc., with project management experience- Equivalent combination of education, training, or experience- Excellent knowledge of Lifecycle Safety processes- Excellent attention to detail and accuracy, maintaining consistently high quality standards- Excellent written and verbal communication skills- Ability to work effectively on multiple projects simultaneously- Organize your workload and effectively time manage competing priorities- Ability to establish and maintain effective working relationships with coworkers, managers, and clientsIQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. They create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Role Overview:You will be responsible for developing and preparing pharmacovigilance agreements for assigned customers. Additionally, you will prepare pharmacovigilance systems master files under direct supervision and act as the deputy EU-QPPV. Your essential functions will include working closely with project teams to determine appropriate terms and conditions of safety agreements, preparing and maintaining PSMFs, and reviewing PSMFs prepared by other specialists. As the primary customer interface on large complex projects, you will be responsible for developing and maintaining customer relationships, providing input to project plans, overseeing finalization and distribution of safety agreements, and assisting in the negotiation of safety agreement text using approved processes and templates. You will also represent the safety agreements team at customer meetings as required, provide input into project budgets involving safety agreements, offer advice, support, and guidance to other staff involved in preparing safety agreements, mentor and train team members, and perform all other duties as assigned.Key Responsibilities:- Develop and prepare pharmacovigilance agreements for assigned customers- Prepare and maintain PSMFs- Review PSMFs prepared by other specialists- Work closely with project teams to determine appropriate terms and conditions of safety agreements- Provide input to project plans to accurately reflect services provided- Oversee finalization and distribution of safety agreements- Assist in the negotiation of safety agreement text using approved processes and templates- Represent safety agreements team at customer meetings as required- Provide input into project budgets involving safety agreements- Offer advice, support, and guidance to other staff involved in preparing safety agreements- Mentor and train team membersQualifications:- Bachelors Degree, preferably in health science or related area- Minimum of 3 years of experience in Lifecycl

Keyskills :
PharmacovigilanceProject ManagementCustomer Relationship ManagementRisk ManagementPublishingMedical Information Safety