Associate Marketed Product Safety Director - Sponsor Dedicated

IQVIA · Bucharest

The Qualified Person Responsible for Pharmacovigilance (QPPV) is a mandatory position Marketing Authorization Holders (MAHs) are required to have when operating as entities in the European Union (EU). The QPPV is responsible for the establishment and maintenance of the MAH’s pharmacovigilance system.

The Associate Marketed Product Safety director is intended to serve as a fully sponsor dedicated deputy QPPV role. The deputy QPPV receives delegation of certain tasks and activities in line with the overall QPPV responsibilities and should be able to work independently and with authority.

To apply for this position, you must permanently reside and work within the European EU or the European Economic Area (EEA).

The main responsibilities include:

Responsibilities related to the PV regulations and the client pharmacovigilance system:

Assist the QPPV in analysing, anticipating, and communicating the impact of emerging regulations on the company pharmacovigilance processes and product portfolio management for assigned marketed products.
Contribute to the construction of the pharmacovigilance regulatory guidance.
Advise and guide the functions involved to help ensure that the pharmacovigilance system required by EU regulations and associated guidance (as amended from time to time) is properly implemented at the client.
Ensure and verify that the information contained in the PSMF is an accurate and up-to-date reflection of the pharmacovigilance system under the QPPV’s responsibility.
Evaluate risks and communicate global impact issues to the QPPV and recommend appropriate action plans.
Participate in mandatory client governance meetings.
Assist in developing the client reputation at health authority level.

Responsibilities related to the assigned product portfolio:

Review and provide advice in management of product-related safety matters, that could impact patient health in relation to the benefit-risk of products.
Provide routine updates on product related issues to the QPPV on a periodic basis.
Timely review and/or approval of documents intended for submissions to regulatory authorities.
Other tasks assigned in line with overall QPPV role.

Skills, experience and qualification required for the role:

At least a Bachelor's Degree from an accredited and internationally recognized institution in Medicine or another healthcare professional degree with a curriculum relevant to this position.
5 years experience in a Contract Research Organization or Pharmaceutical or associated industry, or equivalent combination of education, training and required experience
Broad pharmacovigilance experience, including review and contribution to RMPs and additional risk minimisation measures, DHPC preparation and distribution, safety variations, PSURs/PBRERs, the PSMF, PRAC-related activities, referral procedures, and product alerts.
Previous exposure to safety profile oversight and signal management, including the review and interpretation of safety data and participation in Safety Management Team and signal-adjudication discussions.
Previous interactions with health authorities, particularly regarding safety communications, DHPCs, risk minimisation activities, referral procedures, and other regulatory activities with a safety impact.
Regulatory affairs experience across both centralised and national procedures. This provides valuable end-to-end understanding of how regulatory and pharmacovigilance activities are connected throughout the product lifecycle.
Strong cross-functional collaboration, particularly with regulatory affairs and other stakeholders involved in product safety assessment and decision-making.
The ability to maintain a comprehensive overview of product safety, identify potential safety risks or compliance concerns, and ensure appropriate escalation, follow-up, and documentation.
Ability to maintain an overall view of product safety, identify potential risks or compliance concerns and ensure appropriate escalation and follow-up.
Ability to work on multiple projects and manage competing priorities effectively.
Strong judgment, independent thinking, decision-making and problem solving skills.

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.

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