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reference: 4892938

documentId: 4892938

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stillingsbetegnelse: Compliance Specialist in Global Safety

jobbeskrivelse:

Can you help taking our safety compliance area to the next level?

If you have pharmacovigilance (PV) experience and you are looking for a job where you can unfold all of your skills in a role with great impact and influence, this is it. You will join LEO Pharma in the most exciting period for many years as we are transforming the company to fulfil our goal of becoming the world’s preferred dermatology care partner. Your personal effort will be of importance to patients all over the world, and you can look forward to create results in a welcoming and positive environment of highly skilled and engaged colleagues.

 

PV Compliance monitoring, data handling, deviation management, communication…

Your overall objective is to safeguard PV compliance for all products across development and already marketed products. In close collaboration with two colleagues you will focus especially on managing the global safety quality and compliance system. We also plan to make you the department’s primary driver in a new cross organisational project that will set the directions for the future global compliance monitoring focusing on automated processes to match a rapidly growing business. Your primary tasks will be to:

• Monitor PV quality and compliance performance in collaboration with LEO affiliates and partners

• Collect, compile and analyse compliance data to be used in to monthly KPI measures

• Ensure ongoing and proactive communication of compliance status and risks to the QPPV and other key stakeholders

• Handle emerging compliance issues and identification of adequate actions

• Handle deviations and CAPA management

As the compliance specialist you are a focal point vital in the communication of expected quality standards across the global LEO safety organisation. As such, you will be a key player in our on-going promotion of a good quality and compliance mindset.

 

 Solid experience within drug safety and/or pharmacovigilance

Your foundation is probably a university degree within natural science or similar. More important is your minimum of 5 years’ experience from working within the field of drug safety and/or pharmacovigilance. If you have specific experience from compliance or quality related tasks it is beneficial but not a prerequisite for applying. You must bring a good basic IT technical understanding including skills in Excel – you will not need to be a programmer but you must be able to understand how data and numbers are generated in order to identify potential errors and see rooms for improvements.

You must thrive in a very outgoing role, as your success to a wide extent will depend on your ability to establish a constructive relationship to multiple colleagues and stakeholders across the global LEO safety organisation as well as to external LEO partners. This takes good communication skills and written and spoken English as well as the ability to see a problem at hand from other angles than your own. It is critical that you can balance your good overview and strong sense of details whilst being a guardian of quality.

 

Your new team

You will join 6 skilled and dedicated colleagues in Global Safety Compliance based in Global Safety at the LEO Pharma headquarters in Ballerup, Greater Copenhagen. We are globally responsible for managing the compliance of LEO Pharma’s Pharmacovigilance System. This includes also maintenance of the PV System Master File, PV training setup, PV contract management, PV audits and inspection management. We see ourselves as constructive business enablers, and we are proud of our contribution to development of safe and reliable products. 

We believe that the best results are made in an atmosphere of trust and respect for the individual and we simply care about each other. As such, we can promise you that you will be part of a very good workplace with room for knowledge sharing, mutual inspiration and having a good time together.

We look forward to receiving your application.

The application deadline is 15-Nov-2018 although interviews may be scheduled before the deadline. Contact person: Irene Rasmussen (+45 4137 1109)

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2423

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: LEO PHARMA A/S

source: DK-STAR