# Associate Marketed Product Safety Director

**Company**: IQVIA
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Bucuresti-Romania/Associate-Marketed-Project-Safety-Director---Sponsor-Dedicated_R1576213?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_380c8409-193

## Description

The Associate Marketed Product Safety Director will serve as a fully sponsor-dedicated deputy QPPV role, supporting the Qualified Person Responsible for Pharmacovigilance (QPPV) in establishing and maintaining the pharmacovigilance system for Marketing Authorization Holders (MAHs) operating in the European Union (EU).

**Main Responsibilities:**

- Assist the QPPV in analyzing, anticipating, and communicating the impact of emerging regulations on the company's pharmacovigilance processes and product portfolio management for assigned marketed products.

- Contribute to the construction of pharmacovigilance regulatory guidance.

- Advise and guide functions involved to ensure the pharmacovigilance system required by EU regulations is properly implemented.

- Ensure and verify that the information contained in the PSMF is accurate and up-to-date.

- Evaluate risks and communicate global impact issues to the QPPV and recommend action plans.

- Participate in mandatory client governance meetings.

- Assist in developing the client's reputation at health authority level.

**Product Portfolio Responsibilities:**

- Review and provide advice on product-related safety matters that could impact patient health.

- Provide routine updates on product-related issues to the QPPV.

- Timely review and/or approval of documents intended for submissions to regulatory authorities.

- Other tasks assigned in line with the overall QPPV role.

**Requirements:**

- At least a Bachelor's Degree in Medicine or another healthcare professional degree with a relevant curriculum.

- 5 years of experience in a Contract Research Organization or Pharmaceutical or associated industry.

- Broad pharmacovigilance experience, including review and contribution to RMPs, DHPC preparation and distribution, safety variations, PSURs/PBRERs, and PRAC-related activities.

- Previous exposure to safety profile oversight and signal management.

- Previous interactions with health authorities, particularly regarding safety communications and risk minimization activities.

- Regulatory affairs experience across both centralized and national procedures.

- Strong cross-functional collaboration and ability to maintain a comprehensive overview of product safety.

- Ability to work on multiple projects and manage competing priorities effectively.

- Strong judgment, independent thinking, decision-making, and problem-solving skills.

## Skills

### Required
- Pharmacovigilance
- Regulatory Affairs
- Risk Management
- Signal Detection
- Safety Profile Oversight
- Health Authority Interactions

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Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Bucuresti-Romania/Associate-Marketed-Project-Safety-Director---Sponsor-Dedicated_R1576213?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)