Marketed Prod Safety Spec 2

IQVIA; Thane; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

IQVIA in India seeks a Pharmacovigilance professional to develop and prepare pharmacovigilance agreements for assigned customers and prepare PSMFs under supervision, acting as deputy EU-QPPV.

Responsibilities include collaborating with project teams on terms of safety agreements, maintaining PSMFs, mentoring staff, and supporting budgets and customer relationships on large, complex projects.

Qualifications

• 3 years' experience in Lifecycle Safety (Pharmacovigilance, CEVA, Medical Information, safety publishing, Risk Management) with project management experience.
• Excellent knowledge of Lifecycle Safety processes.
• Excellent written and verbal communication skills.
• Ability to manage multiple projects simultaneously.

Responsibilities

• Develop and prepare pharmacovigilance agreements for assigned customers.
• Prepare pharmacovigilance systems master files under supervision.
• Act as deputy EU-QPPV.
• Review PSMFs and mentor team members.
• Provide input to project plans and budgets related to safety agreements.

Skills

Lifecycle Safety

Project management

Attention to detail

Communication skills

Education

Bachelor's Degree in health science

Job description

Job Overview

Develop and prepare pharmacovigilance agreements for assigned customers. Prepare pharmacovigilance systems master files under direct supervision. Act as deputy EU- QPPV.

Essential Functions

• Work closely with project teams to determine appropriate terms and conditions of safety agreements.
• Develop and prepare safety agreements.
• Prepare and maintain PSMFs.
• Review PSMFs prepared by other specialists. Primary customer interface on large, complex projects, responsible for developing and maintaining customer relationships.
• 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.
• Provide advice, support and guidance to other staff involved in preparing safety agreements.
• Mentor and train team members.
• Perform all other duties as assigned

Qualifications

• Bachelor's Degree Preferably in health science or related area Req
• 3 years' experience of 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 and maintain consistently high quality standards.
• Excellent written and verbal communication skills.
• Ability to work effectively on multiple projects simultaneously.
• Organize own workload and effectively time manage competing priorities.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.