Position: Pharmacovigilance Specialist

Meditrial is a full-service clinical research organization (CRO) dedicated to clinical trial conduct, medical education, regulatory affairs and market access. Our offices are located in Germany, Italy, Switzerland, UK, United States and our teams rely on digital tools to work collaboratively to achieve shared goals.

Since 2008, Meditrial delivers unparalleled outcomes for innovators. Our successful track record supporting the lifescience industry manufacturers in all phases of clinical development puts us in a prime position to seize the opportunity to emerge as a leader in digital technology with the promise that it will enhance and alleviate the clinical trial and participant burden. Through our work, the patient and innovator are empowered with data and insights across the lifecycle of product development and market penetration changing the paradigm of care towards understanding and value. We have the ability to transcend the current landscape with “smart” technology enabled data collection tools and insights.

Meditrial offers highest level expertise across multiple therapeutic areas. We are passionate about our mission to support the innovation and development of better therapies in compliance with solid ethical standards. Our commitment has resulted in excellent results for business growth by creating stability and opportunities for employees and collaborators.

**Position: Pharmacovigilance Specialist**:
**Industry**: Lifescience Industry: Pharma, Medtech, Digital Health

**Employment Type**: Full-time

**Job Functions**: Pharmacovigilance

**Location**: Meditrial Srl, Rome, Italy

**Workplace**: In Office

The Pharmacovigilance Specialist, preferably EU-QPPV, will be responsible for the establishment and maintenance of the marketing authorisation holder’s pharmacovigilance system, having an overview of medicinal product safety profiles and any emerging safety concerns. The role should have deep understanding and awareness of any conditions or obligations adopted as part of the marketing authorisations and other commitments relating to safety or the safe use of the products.

**Responsibilities**:
having awareness of risk minimisation measures;
being aware of and having sufficient authority over the content of risk management plans;
being involved in the review and of protocols of post-authorisation safety studies conducted in the EU or pursuant to a risk management plan agreed in the EU;
having awareness of post-authorisation safety studies requested by a competent authority including the results of such studies;
ensuring conduct of pharmacovigilance and submission of all PV-related documents in accordance with the legal requirements and GVP;
ensuring the necessary quality, including the correctness and completeness, of pharmacovigilance data submitted to the competent authorities in Members States and the Agency;
ensuring a full and prompt response to any request from the competent authorities in Members States and from the Agency for the provision of additional information necessary for the benefit-risk evaluation of a medicinal product;
providing any other information relevant to the benefit-risk evaluation to the competent authorities in Members States and the Agency;
providing input into the preparation of regulatory action in response to emerging safety concerns (e.g. variations, urgent safety restrictions, and communication to patients and healthcare professionals);
overseeing safety and benefit-risk profiles for all respective client products and any emerging safety concerns;
having access to the data processing system in order to answer urgent requests;
being aware of the validation status of the adverse reaction database
triggering audits where appropriate and assuring implementation of corrective and preventive actions resulting from each audit relevant to the PV system;
ensuring and verifying that the information contained in the Pharmacovigilance System Master File (PSMF) is an accurate and an up-to-date reflection of the PV system;
acting as a single pharmacovigilance contact point for the competent authorities in Member States and the Agency on a 24-hour basis and also as a contact point for pharmacovigilance inspections and audits;
Skillset & Qualifications
- Education in Medicine, Pharmacy or Life Science
- Long-lasting experience and profound knowledge in the field of pharmacovigilance as well as in dealing with pharmaceutical issues
- Expertise, experience and knowledge regarding relevant legislative and non-legislative guidelines on pharmacovigilance
- Detailed knowledge of related SOPs (global and local)
- Participation in all relevant courses of instruction such as company-internal trainings and applicable external courses
- Very good command of English
- Ability to analyse and solve problems and to develop possible solutions
- Demonstrated experience of proactively driving a variety of tasks and projects and delegating to team members