Pharmacovigilance Product Safety Specialist

IQVIA; Thane; Vor Ort; INR 900.000 - 1.300.000; Vollzeit

Zusammenfassung

IQVIA seeks a Marketed Prod Safety Spec 2 to develop pharmacovigilance agreements and PSF/MF documents, while acting as deputy EU-QPPV. You will collaborate with project teams to shape safety terms and ensure high-quality PV deliverables across complex projects.

The role emphasizes customer-facing responsibilities, process-driven negotiation, and mentorship within a seasoned lifecycle safety team. Suitable candidates hold a health science degree and 3+ years of PV experience.

Qualifikationen

• Bachelor's degree in health science or related area.
• 3 years' Lifecycle Safety experience with project management.
• Excellent knowledge of Lifecycle Safety processes.
• Excellent attention to detail and accuracy; high quality standards.
• Excellent written and verbal communication skills.
• Ability to work on multiple projects simultaneously.
• Organize workload and manage competing priorities.
• Ability to establish and maintain effective working relationships.

Aufgaben

• Develop and prepare pharmacovigilance agreements with assigned customers.
• Prepare pharmacovigilance systems master files under supervision.
• Act as deputy EU-QPPV.
• Interface with customers as primary contact on large, complex projects.
• Provide input to project plans reflecting services provided.
• Oversee finalization and distribution of safety agreements.
• Assist in 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.
• Mentor and train team members.

Kenntnisse

Lifecycle Safety

Project management

Communication

Attention to detail

Multitasking

Time management

Relationship building

Ausbildung

Bachelor's degree in health science or related area

Jobbeschreibung

Marketed Prod Safety Spec 2 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.