Arbejde Senior Specialist Pharmacovigilance unspecified ZEALAND PHARMA A/S - jobtilbud

GÆLDER
id: NDk3NTk5NCA3

reference: 4975994

documentId: 4975994

connectionPointId: 7

lastModificationDate: 1555331417820

stillingsbetegnelse: Senior Specialist Pharmacovigilance

jobbeskrivelse:

Are you passionate about making a true difference for patients with rare diseases? Are you also thinking of making a career change and be part of a very dynamic, ambitious, professional, yet lean and agile team where you can have influence?

Then you may be our new colleague in Regulatory, Pharmacovigilance and Medical Writing. Zealand Pharma A/S (Zealand) is looking for a Pharmacovigilance Senior Specialist who will report to the Head of Pharmacovigilance. This is a new position.

The Senior Specialist will have as key responsibilities: 

  • Ongoing safety surveillance 
  • Signal management 
  • Aggregated safety reporting

The Job Requirements 

  • Execution of safety surveillance activities for the clinical projects assigned 
  • Execution of signal detection activities, to support the evaluation and decisions of Zealand Safety Committee 
  • Preparation of high quality periodic safety reports (DSUR, periodic SUSAR reports) 
  • Preparation of Risk Management Plan (RMP) and/or Risk Evaluation and Minimization Strategies (REMS) documents 
  • Support the design and execution of the assigned clinical programs from a clinical safety perspective 
  • Provide drug safety expertise to project teams, including all relevant documents prepared for regulatory submissions for the assigned clinical programs.

The Candidate Profile

The successful candidate will have: 

  • MD or Pharmacist degree or other natural sciences degree; additional Pharmaceutical Medicine or Pharmacovigilance degree will be an advantage 
  • At least 7 years of in-depth, hands-on work experience with the PV processes applied in safety surveillance (including safety analysis, signal management, DSUR/PSUR, RMP/REMS, internal safety committees, communication with regulatory authorities)
  • Solid understanding of the PV (EU and FDA) requirements
  • Experience with device and drug-device combination products regulatory reporting 
  • Strong analytical skills 
  • Ability to communicate and interact maturely with internal and external stakeholders 
  • Strong ethical standards 
  • Quality mind-set 
  • Team-player mindset

What we offer

Zealand’s employees are one of the company’s most important assets. We strive to attract, develop and retain the best talents, and to be a company where every employee can thrive.

At Zealand, we understand the value of a diverse workforce. As an employee, you will be part of an innovative, cross-disciplinary and cross-cultural working environment.

We offer a combined salary package including pension scheme and health insurance, as well as the option of joining the company lunch program, and use of massage, fitness and social facilities.



numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2421

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: ZEALAND PHARMA A/S

source: DK-STAR

GÆLDER

Similiar jobtilbud

Analog IC Design Manager -

Analog IC Design ManagerYou will be part of our Silicon Engines department at Oticon, where we develop the chipsets used in our hearing instruments and accessories. The goal is to ensure technological leadership in our products by developing state-of-the-art innovative silicon solutions, featuring world-class
OTICON A/S - 2018-12-18 - unspecified

Behandlingsinstitutionen Magnoliegården søger lærer til den interne skole - Genopslag -

Da en af vores lærere har valgt nye udfordringer i Stevns Kommune, søger vi en lærer til vores interne skole med tiltrædelse snarest muligt Magnoliegården er en specialiseret døgnbehandlingsinstitution hvor relationsarbejde er i centrum. Institutionen består af 3 døgnafdelinger og intern skole.
Magnoliegården - 2018-12-06 - unspecified

Cloud Solutions Architect Manager - Data and AI -

Microsoft aspires to help our customers achieve their own digital transformation, leveraging the power of Microsoft Cloud solutions and services. To this end, Microsoft is investing in a dedicated Customer Success team that is at the forefront of transformation, helping inspire Microsoft customers
MICROSOFT DANMARK APS - 2019-04-25 - unspecified

Consultant, Asset Management -

Delivering superior asset management services and advisory in one of the world´s leading, independent consultancies within the renewable industry   We experience a rapid growth in the demand for our services in both established and new markets all over the world and thus also an increased
K 2 MANAGEMENT A/S - 2018-11-28 - unspecified

Deltid eller fuldtid til et Havecenter -

unspecified
Din Gartner / HCS Environmental Services - 2019-04-20 - unspecified

Director, Cooling Strategy -

(Location: Denmark, Germany)Job DescriptionDanfoss is on the lookout for a Director of Strategy for Danfoss Cooling Segment. The successful candidate will take on the lead to become a strategic advisor to senior management and will drive and support main strategic initiatives within the Segment. From
DANFOSS A/S - 2019-02-13 - unspecified

Ekspedient der er glad for mad -

Gourmandiet åbner på AmagerVi har brug for en ekspedient med solid erfaring fra fødevarebutik til vores nye butik på Kongelundsvej på Amager. Det bliver en flot butik med et stort udvalg af kvalitetsmad, herunder fersk kød, færdigretter og også vegetariske
Gourmandiet Amager - 2018-08-29 - unspecified

Er du vores nye ungerådgiver i headspace Esbjerg? -

Vi søger en initiativrig, engageret og selvstændig ungerådgiver til headspace Esbjerg.headspace er et initiativ under Det Sociale Netværk. Vi tilbyder gratis og anonym rådgivning til børn og unge i alderen 12-25 år, som har brug for nogen at tale med. I headspace er intet problem for stort eller
Headspace Esbjerg - 2018-11-13 - unspecified

Experienced RPA developer to deliver next generation solutions -

Do you want to impact the future of work through automation and be part of an innovative Process Automation team? Join us and become Senior Automation Architect in Ørsted Process Automation where you’ll be responsible for delivering solutions, influencing stakeholders to build and
Ørsted Vind A/S - 2018-09-13 - unspecified

Finance Business Partner - Aarhus -

Would it motivate you to apply your solid financial and commercial skills in a fast growing international production company? Do you have both experience and drive to undertake a far-reaching role with touch points across our organisation?This could be your chance to enter into the Finance team in Arla
ARLA FOODS AMBA - 2019-02-06 - unspecified

Laboratory Technician, In-vivo Pharmacology -

Gubra is seeking a Laboratory Technician to join our highly interactive Pharmacology Research Department consisting of animal technicians, laboratory technicians, and scientists.  In Pharmacology Research, we work with a
GUBRA ApS - 2018-11-07 - unspecified

Mekaniker søges -

Vi søger en mekaniker til vores værksted.Vi laver alle bilmærker, så du skal helst have lidt styr på de fleste mærker.Værkstedet er 1 år gammelt, så alt er helt nyt.Vi ser at du er velsoigneret, pæn og præsentabel samt mødestabil.Arbejdspladsen ligger i Vejle nord.Ved interesse, kontakt mig
Martin Kristensen Biler ApS - 2019-02-22 - unspecified

Node.js/JavaScript Developer -

Actimo is redefining internal communication processes across the retail, trade and industry sectors by offering a responsive digital platform. We challenge the modern workforce – more often than not, comprised of geographically dispersed non-desk employees. Our intuitive design makes it easier
ACTIMO ApS - 2018-08-10 - unspecified

Økonomi- og administrativ medarbejder -

Administrativ/økonomi medarbejder til Hafnia-Hallen Hafnia-Hallen åbnede i april 2017 og efter 15 måneders travlhed ønsker vi at opgradere vores administrative platform, så en administrativ deltidsstilling opgraderes til fuldtid. Derfor slår vi nu denne spændende
S/I Hafnia-Hallen - 2018-08-09 - unspecified

Operations Manager -

National Life Science Supercomputing Center is looking for an Operations Manager. Do you want to be part of a National Life Science Supercomputing Center at DTU with responsibility for our infrastructure on our supercomputer? And would you like to ensure that we provide stable and safe operation of
Danmarks Tekniske Universitet - 2019-02-01 - unspecified

Pædagoger søges til Fritidsinstitutionen ved skolen ved Sundet -

  Vi søger 4 dygtige pædagoger på 28 timer om ugen til matriklen på Kaldæavej 14, henholdsvis i vores 0. klassehus, 1-2 klassehus og vores 3.klassehus. Fritidsinstitutionen ved Skolen ved Sundet er et selvejende fritidsinstitution, hvor der går 366 børn
SKOLEFRITIDSHJEMMET PÅ SKOLEN VED SUNDET - 2018-09-11 - unspecified

pratikplads med speciale Smørrebrød og Cater -

Vi søger en elev til en ledig praktikplads i specialet Smørrebrød. På Mortens kro har vi stor succes med vores fortolkning af smørrebrød i en moderne udgave, vores fagudannede kokke arbejder med friske råvare og vi producere hverdag mange smukke stykker smørrebrød- samt kolde anretninger både
Mortens Kro v/ Morten Nielsen - 2019-02-13 - unspecified

Rengøringsinspektør i Jylland. -

All Remove Danmark A/S er en serviceminded virksomhed i vækst.Vi har eksisteret i over 30 år og har i Danmark afdelinger i København, Odense og Århus.I All Remove er vi sandsynligvis mest kendt indenfor anti-graffiti, men igennem årene er forretningsområderne udvidet betydeligt. Således fremstår
All Remove Danmark A/S , Jyllands afd. - 2019-04-09 - unspecified

Safety Instructor -

About Siemens Gamesa Renewable Energy With a worldwide installed capacity of 75 GW, Siemens Gamesa Renewable Energy has a presence in more than 90 countries and a team of 27,000 employees worldwide. Its end-to-end value chain presence encompasses onshore and offshores wind turbines design, manufacturing,
Siemens Gamesa Renewable Energy A/S - 2018-09-20 - unspecified

Savværksarbejder -

unspecified
DAVINDE SAVVÆRK A/S - 2018-12-08 - unspecified

Selvkørende bogholder med gennemslagskraft der kan overholde deadlines og har overblik og stærk ordensans -

Vi søger en erfaren pligtopfyldende bogholder der kan trives i et hektiskt og dynamiske miljø.Vi er en solid jysk rengøringsvirksomhed med en stærk faglighed samt høj kvalitet og med et godt ry i hele Danmark.Som bogholder har du et tæt samarbejde med ledelsen som dine nærmeste sparingspartnere.Derudover
PALMGREN ERHVERVSRENGØRING ApS - 2019-03-24 - unspecified

Senior Manager for Mould Design -

Are you ready to lead a team of experienced specialists and help us strengthen our position as a global trendsetter within the toy industry?Join us to use your leadership skills and technical understanding to create a change in our Mould Design team in Denmark.Transform Mould Design with focus on productivity
LEGO SYSTEM A/S - 2018-12-13 - unspecified

Senior Marketing Manager to LEGO Retail Global Marketing -

Senior Marketing Manager to LEGO Retail Global MarketingDo you want to use your extensive marketing experience to create marketing campaigns that engage shoppers and consumers worldwide? Take this opportunity to impact how we sell the LEGO® products to LEGO enthusiasts globally and see your ideas come
LEGO SYSTEM A/S - 2019-03-14 - unspecified

Skarp og omstillingsparat debitorbogholder til vækstende virksomhed -

For vores kunde i Målev, nær Ballerup, søger vi en dygtig, ambitiøs og humoristisk debitorbogholder. Du kommer til at arbejde tæt sammen med regnskabsafdelingen, men også finansafdelingen, som tilsammen består af 24 kommende kollegaer. Virksomheden har ambitiøse
RAMSDAL PROFIL MATCH ApS - 2018-08-25 - unspecified

Specialist in Generators -

Do you want to influence how the future of generators looks? We work with state-of-art technology and seek the best of the best to make sure that we stay in front of the development within generators.  If that sounds like a challenge for you, then become our new Specialist in Generators and help
Vestas Wind System A/S - 2019-04-10 - unspecified

Specialist, Total Rewards -

(Location: Flexible) Job Description Are you interested in working with Total Rewards in a global environment? Are you ready for an extensive personal and professional development within the HR area? We have an open position as Specialist in our Total Rewards team, and you could be our next teammate
DANFOSS A/S - 2018-09-21 - unspecified

Student Assistant in Inventory Management -

Job DescriptionAre you a current student seeking to combine your studies and theoretical knowledge with practical experience from an international, high performing energy organization?And are you interested in kick-starting your career within procurement and supply chain?If yes, then this student assistant
Total E&P Danmark A/S - 2019-03-02 - unspecified

Thai takeaway på Østerbro søger en deltids ekspedient 5-10 timer ugentligt -

Kvalifikationer: -Du skal have erfaring inden for servicebranchen  -Du skal være stabil  -Alder mellem 20-35 år -Du skal være smilende og udadvendt -Du skal kunne håndtere travlhed og have overblik -Du er hjælpsom -Er ikke bange for at tage fat   Arbejdsopgaver:
Rice and Rice - 2018-09-26 - unspecified

Vejleder til Døgn & Familiestøtte Herning -

Er din faglige og personlige rygsæk stærk? Drives du af respekt for, at familier gør deres bedste i forhold til deres børn og unge og kan du finde løsninger sammen med en familie i vanskeligheder? Så er du måske den vi mangler til et barselsvikariat i vejledningsteamet i Døgn og familiestøtte
Herning Kommune - 2019-02-19 - unspecified

Workbook API integration -

Note: Dette er et freelancejob på Worksome - Danmarks største platform for professionelle konsulenter og freelancere. Se mere om virksomheden og stillingen og ansøg via Worksome her: https://use.worksome.dk/job/6251 VIGTIGT: du skal have erfaring med Workbook\'s API for at søge dette job.Opgaven
Worksome ApS - 2018-12-12 - unspecified