Local Drug Safety Officer

2 mesi fa

Roma, Italia Merck KGaA Darmstadt Germany A tempo pieno

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

**Your role**:
As the Local Patient Safety Officer (LPSO) you will be accountable to ensure full compliance with all relevant global and local pharmacovigilance (PV) regulatory requirements and to ensure the secure functioning of the local PV system by leading and executing operational PV tasks and maintaining of the local PV File. You will be accountable for proper handling of all local safety reporting and to assure transmission to global in a timely manner as well as performing screening of relevant local medical/scientific literature and local Health Authority website, and for continues monitoring of local PV legislation in the country. You will also be accountable for managing local PV vendors and for providing PV Training to relevant local functions and 3rd parties as necessary. You will be involved in the implementation and oversight of Risk Management Plans (RMPs) and additional Risk Minimization Measures as required in close collaboration with the local and global teams and will have an oversight of all ongoing study / Patient Data Collection Systems (PDCS) activities. You will be nominated as a contact person for internal and external safety-related matters to the local Health Authority and will exchange information with the Patient Safety Center (PSC) Mediterranean manager as his line manager and local key stakeholder functions.

**Who you are:
- Medical doctor, pharmacist, bioscientist or similar qualification with experience in the pharmaceutical industry, in an affiliate setting preferably as local responsible for patient safety
- Excellent written and spoken English on top of Italian, additional languages are an asset
- Knowledge of regional and local PV requirements
- Good understanding of drug development and life-cycle management
- Strong intercultural skills and strong team-working skills
- Excellent problem-solving and decision-making ability and excellent organizational skills, ability to prioritize work and adapt rapidly to changing priorities
- Effective presentation and training skills

**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

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