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Erfaren Pharmacovigilance specialist (+4 års erfaring)

A-consult group søger en ny kollega med mindst 4 års erfaring inden for Pharmacovigilance. Din erfaring må gerne være bred og opnået gennem flere ansættelser indenfor medicinal- og medicobranchen.


Du vil indgå i et team af erfarne konsulenter, som rådgiver A-consult groups kunder indenfor alle aspekter af Pharmacovigilance; fra vurdering af bivirkninger, udarbejdelse af PSUR, RMP, signal detektion, audits til varetagelse af deputy QPPV rollen.
 Du kan endvidere komme til at rådgive i opbygning og vedligeholdelse af Pharmacovigilance systemer, både A-consult groups eget og kunders.


Jobbet indeholder en bred vifte af varierende opgaver indenfor Pharmacovigilance. Du vil skulle yde service til vores kunder og intern support til vores øvrige medarbejdere, både Pharmacovigilance, Regulatoriske og QA kolleger.

Opgaverne varetages for danske, nordiske og internationale kunder. Derfor er samarbejde med kunder og vedligehold af kunderelationer en vigtig del af dit arbejde.

I samarbejde med kunderne vil du afklare og beskrive kundens behov, vurdere den bedste løsning for kunden, samt estimere tidsforbrug for løsning af opgaven. Du vil oftest være tovholder på de opgaver, du har ansvaret for.

Vi vil meget gerne høre fra dig, hvis du kan lide at blive udfordret inden for dit fag, og du:

  • har en akademisk naturvidenskabelig uddannelse
  • har mindst 4 års bred erfaring inden for Pharmacovigilance og vigilance (medicinsk udstyr)
  • har lyst til at lede og arbejde med projekter
  • har et sikkert overblik over GVP, relevante EU guidelines og procedurer, og en god erfaring af fortolkning af disse
  • er vant til at arbejde med mangeartede opgaver

 

Sprog:
Flydende i dansk og engelsk samt gerne god forståelse af et eller flere skandinaviske sprog.
Kendskab til fransk vil være en fordel.

Personlige egenskaber:
Du er fleksibel og i stand til effektivt at løse opgaver baseret på indsigt i kundens processer og problemstillinger kombineret med forståelse for de relevante EU-direktiver. Du har et godt overblik og er i stand til hurtigt at sætte dig ind i en opgave. Du trives med rådgivningsrollen og at hjælpe andre godt i hus. Du udviser engagement og troværdighed, og du tager ansvar og selvstændige initiativer til at skabe resultater. Du er selv aktiv i at identificere og drive forbedringer og forandringer, og du udfordrer det bestående på konstruktiv vis. Du har gode kommunikationsevner og er god til at samarbejde med andre faggrupper. Du er udadvendt og trives med at skabe kontakt til andre mennesker.

Uddannelse:
Naturvidenskabelig uddannelse, som f.eks. farmaceut, læge, tandlæge eller humanbiolog.

Fagligt område:
Pharmacovigilance inden for farma- og medicobranchen

Arbejdssted:
A-consult groups kontor ligger i Gladsaxe. Det daglige arbejde vil som udgangspunkt foregå fra A-consult’s kontor, men kan, i kortere eller længere perioder, foregå hos vores kunder.

Yderligere information:

Hovedparten af vore projekter modtager vi fra store og mindre farma og medico virksomheder, der benytter vores rådgivning til såvel sparring som specialopgaver, eller total eller delvis outsourcing af deres Pharmacovigilance system.

Vi er indstillet på at give dig en løn, der svarer til din relevante erfaring. Du vil desuden blive omfattet af vores sundhedsforsikring. Vi er tæt på offentlige transportmidler og motorveje og har gode parkeringsforhold.

Hvis du har lyst til nye udfordringer, så send en skriftlig ansøgning til os enten pr. post eller e-mail på job@a-consult.dk eller skriv direkte til Inge Jeding-Jansen, ijj@a-consult.dk, for yderligere oplysninger.

Ansøgningsfristen er 17. september 2017, men vi tager løbende ansøgere til samtale.

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Experienced Pharmacovigilance Specialist (+4 years of experience)

A-consult group is looking for a new colleague with at least 4 years of experience in Pharmacovigilance. Preferably your experience is broad and with several employments in the pharmaceutical and medico industry.

You will be part of a team of experienced consultants who advise A-Consult group’s clients in all aspects of Pharmacovigilance;  from evaluation of Adverse Events, writting of PSUR, RMP, signal detection, audits to acting as deputy QPPV role. You are able to advise in building and maintaining Pharmacovigilance Systems, both A-Consult group's own and the client's systems.

The job contains a wide range of varied tasks within Pharmacovigilance. You will be providing both services to our clients and internal support to our other employees, both Pharmacovigilance, Regulatory and QA colleagues.

The tasks are handled for Danish, Nordic and international clients. That’s why collaborating with clients and maintaining client relations is an important part of your work.

In cooperation with the clients, you will clarify and describe the client's needs, evaluate the best solution for the client, and estimate the time needed for solving the task. You will usually be the coordinator for the tasks for which you are responsible.

We would love to hear from you if you like to be challenged within your field and you:

  • Have an academic scientific education
  • Have at least 4 years of experience in Pharmacovigilance and vigilance (medical devices)
  • Want to manage and work with projects
  • Have a good overview of GVP, relevant EU guidelines and procedures and experience in interpretation of these
  • Are used to working with many tasks

 

Languages:

Fluent in Danish and English as well as a good understanding of one or more Scandinavian languages.

Knowledge of French will be an advantage.

 

Personal characteristics:

You are flexible and able to effectively solve tasks based on insights into client processes and issues combined with an understanding of the relevant EU directives. You have a good overview and are able to quickly understand a task. You enjoy the counselling role and to guide others to a good result. You show commitment and credibility, and you take responsibility and independent initiatives to create results. You are active in identifying and conducting improvements and changes, and you challenge current processes in a constructive way. You have good communication skills and are good at working with other professionals. You are outgoing and thrive on making contact with other people.

 

Training:

Scientific education such as pharmacist, doctor, dentist or human biologist.

 

Professional area:

Pharmacovigilance in the pharmaceutical and medico industry

 

Place of work:

A-consult's office is located in Gladsaxe. The daily work will usually take place from A-consult's office, but may take place at our client’s office for shorter or longer periods of time.

 

More information:

The majority of our projects are received from large and smaller pharmaceutical and medical companies that use our advice for both sparring and special tasks, or total or partial outsourcing of their Pharmacovigilance system.

You can expect a salary that corresponds to your relevant experience. You will also be covered by our health insurance. We are close to public transport and motorways and have good parking facilities.

If you feel it is time for new challenges, please send us a written application either by letter or e-mail at job@a-consult.dk or write directly to Inge Jeding-Jansen, ijj@a-consult.dk, for further information.

The application deadline is 17 September 2017, but we are continuously interviewing applicants.

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