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Eu Qppv information

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$40.5K

$95.4K

$138.5K

How much do eu qppv jobs pay per year?

As of Jun 11, 2026, the average yearly pay for eu qppv in the United States is $95,411.00, according to ZipRecruiter salary data. Most workers in this role earn between $74,500.00 and $112,000.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as an EU QPPV (Qualified Person for Pharmacovigilance), and why are they important?

To thrive as an EU QPPV, you need a strong background in pharmacy, medicine, or life sciences, with in-depth knowledge of pharmacovigilance regulations and relevant EU legislation. Familiarity with safety databases, signal detection tools, and compliance management systems, along with training such as Good Pharmacovigilance Practice (GVP) certification, is typically required. Excellent leadership, communication, and problem-solving skills set outstanding QPPVs apart, as they must coordinate teams and interact with regulatory authorities. These competencies ensure effective oversight of drug safety, regulatory compliance, and protection of patient health.

What are some of the main challenges faced by a EU QPPV, and how can they be managed effectively?

One of the main challenges for a EU QPPV (Qualified Person Responsible for Pharmacovigilance) is ensuring ongoing compliance with ever-evolving pharmacovigilance regulations across the EU. This often involves staying up to date with legislative changes, managing large volumes of safety data, and effectively coordinating with global and local teams. To manage these challenges, strong organizational skills, regular training, and robust communication channels with internal stakeholders are crucial. Many QPPVs also rely on supportive technologies and external networks to streamline workflows and maintain compliance.

What is an EU QPPV?

An EU QPPV, or European Union Qualified Person Responsible for Pharmacovigilance, is a legally mandated role required for pharmaceutical companies marketing medicines in the EU and UK. The QPPV is responsible for ensuring that the company's pharmacovigilance system complies with regulatory requirements, monitoring the safety of medicines, and acting as the main contact point for health authorities. This role involves oversight of adverse event reporting, risk management, and ensuring that appropriate measures are in place to protect patient safety.
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Eu Qppv jobs near you
Infographic showing various Eu Qppv job openings in the United States as of June 2026, with employment types broken down into 69% Part Time, and 31% Contract. Highlights an 85% Physical, 5% Hybrid, and 10% Remote job distribution, with an average salary of $95,411 per year, or $45.9 per hour.
Regulatory Operations Senior Manager

Regulatory Operations Senior Manager

Navitas Life Sciences

Princeton, NJ • On-site

Full-time

Posted 6 days ago

Job description

Job Description
We are currently seeking a Senior Manager of Regulatory Operations. Within the role you will:
  • Develop and execute novel drug regulatory strategy
  • Develop and manage day-to-day operations through the use of project management and planning tools, create and maintain detailed project timelines
  • Establish sound regulatory advice/position on key development issues, and communicate same to the respective stakeholders
  • Provide a high-level review of client programs and develop strategic plans for clinical, analytical, and process development
  • Ensure development programs are compliant with ICH regulatory requirements and all local country regulatory requirements
  • Initiate, author, and/or collaborate on SOP's, work instructions and Work Flows for the regulatory operations function. e.g. electronic Common Technical Document (eCTD) Investigational and Marketing Applications, and post-marketing compliance maintenance submissions in the United States, Europe, and RoW
  • Author clear and concise regulatory documents (CMC authoring) with oversight of all documents for regulatory submissions and associated messaging
  • Work closely with the development team to ensure overall regulatory strategy, regulatory CMC strategy, and labeling strategy for Pharmaceutical/Biological products are aligned
  • Be the point of contact between the company and the regulatory agency - serve as the regulatory liaison
  • Help strategize a road map for EU expansion: MAA planning (Type of submissions - DCP, CP, NP, MRP, Country(ies) selection for MAA and for being CMS vs. RMS and Inputs to set up EU QPPV Office

Desirable Skills and Experience
  • 10 - 15 years' experience working in a regulated, life science environment
  • Strong project management skills
  • Good interpersonal skills
  • Business development skills
  • Experience in defining organizational strategy, process and change management, KPIs and metrics, resource forecasting
  • Extensive knowledge of global submission standards, including but not limited to FDA, HC, EMA, ICH, eCTD and industry trends for dossier preparation (IND/CTA/NDA/MAA/NDA) and regulatory change management and operations.
  • Knowledge on RoW markets is a plus
  • Experience in medical device regulations is a plus
  • Knowledge of eCTD publishing systems, TRS toolbox, and related tools
  • Sound understanding of regulatory information management concepts and tools needed to perform regulatory operations priorities in support of all business areas

Apply