Pharmacovigilance Professional

**Pharmacovigilance Professional**

Are you passionate about drug safety and pharmacovigilance, and would like to become part of a growing company?

Would you like to become part of the change, taking an active part in it?

**The position**

As our Pharmacovigilance Professional you will manage all safety information for Novo Nordisk’s products that are currently marketed or under development worldwide, by ensuring the correct and timely handling of adverse events and technical complaints in the company, the submission of the reports and the compliance with law and internal procedures as the Pharmacovigilance Local Contact Person Back-up.

Some of your responsibilities will be to:

- Handling of safety information for marketed products; write and edit the case narrative, determine and perform appropriate case follow-up, quality control of entered safety information in the pharmacovigilance (PV) database, tracking, archiving and monthly signalling.
- Reviewing, updating and implementing PV business procedures documented in SOPs, guidelines and User Manuals, as well as reviewing Safety Data Exchange Agreements and reconciliation with contractual partners. We will expect a continuous implementation, improving and simplifying internal procedures to keep workload manageable.
- Safety related activities in affiliate owned programmes such as: assessment of vendors, review and approve Safety Data Exchange Agreements (SDEAs), train vendors as well as internal teams, perform reconciliation of Safety Information with the vendor, inspection and audit readiness.
- Following, analysing and implementing national safety legislations. Review, approval and communication to local HA of Promotional Materials. Provide support regarding local requirements.
- Back-up for Regulatory Affairs tasks, supporting the Regulatory Affairs colleagues whenever needed.

**Qualifications**
- Minimum Bachelor on health science
- Proven experience of at least 2 years in a pharmacovigilance department
- Good understanding of European and local regulatory framework
- Fluent in English and Spanish
- Quality oriented with focus on delivering results, planning and organising skills. Also, great communication abilities are a must in order to be able to work cross-functionally, having a high team working spirit.

**About the Department**

You will be part of the Spanish affiliate, joining a highly professional and growing team of 5 people in the Regulatory Affairs & Safety department.

Working at Novo Nordisk is never just a job - it’s the opportunity for a life-changing career.

As Pharmacovigilance Professional you will interact with internal and external customers such as HQ, Clinical, Medical Affairs, Marketing, Sales, Market Access, Business Information, Quality Assurance, Compliance, AEMPS, trade associations (FarmaIndustria, AEFI ), partners and external vendors.

We can guarantee you a highly dynamic environment and a world of opportunities.

**Contact**

If you believe you are qualified and are willing to take the challenge, please submit your updated CV in our platform.

**Deadline**

**Working at Novo Nordisk**

Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we’re life changing.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and the communities we operate in.

We are leaders by making a difference for people who face chronic diseases and work with high standards to bring the ultimate innovation to who needs improved quality of care and life. Each day we are one step closer into changing chronic diseases. And we do so by relying and supporting our people, their career development and continuously bring their best to contribute to a joint mission.