Vacancy: (Junior) Consultant Quality

DADA CONSULTANCY B.V. (www.dada.nl) is a leading, independent and international consultancy agency in the field of international regulatory affairs, development, registration and pharmacovigilance of medicines and medical products (human and veterinary). DADA is located in a modern office in Nijmegen (the Netherlands) and has also a team in Gdańsk (Poland). In total DADA has 40 employees.

DADA is a young and fast-growing company characterized by its high quality of service and by an open and informal atmosphere at the office. You will work in a dynamic and enthusiastic team of 16 employees.

To support our Quality Team of the Regulatory Affairs department, we are looking for a:

 

 

(Junior) Consultant Quality

32 – 40 hours per week

 

 

What are you going to do?

You will support clients in development and maintenance of the GMP – GDP Quality Management Systems, Supply Chain Management and prepare Standard Operating Procedures, Risk Assessments Reports, Quality / Technical Agreements, applying for MIA and WDA.

 

What is your background?

We are looking for a highly motivated colleague with the following background:

  • BSc / MSc preferably in pharmacy, chemistry, life sciences or related;
  • Preferably 1 to 2 years’ experience in GMP – GDP Quality Assurance;
  • Preferably experience in Supply Chain Management;
  • You work accurately and you have a compliance mind-set to perform according to procedures;
  • You have a strong drive to manage projects accurately and timely;
  • You have good communication skills;
  • You master the English language in speech and writing and it is a plus if you also speak Dutch;
  • Time management is not a problem for you! You are perfectly capable of setting your own planning and priorities;
  • You have a professional attitude;
  • You like to work in a team;
  • You are open to (proposing) change and will take the initiative when necessary;
  • You continue to develop by, among other things, actively learning from work experiences.

 

What can you expect from us?

An interesting, varied and dynamic work environment with nice colleagues. Of course, DADA will offer you excellent primary and secondary employment conditions. We also offer you development and growth opportunities within our organization.

 

Are you interested? We would like to receive your CV and motivation letter in English.

 

DADA Consultancy BV

T.a.v. Steffie Dirks, Allround Staff Assistant

Godfried Bomansstraat 31

6543 JA Nijmegen

Or send an e-mail to office@dada.nl

 

For our privacy policy we kindly refer you to our site: www.dada.nl

Please do not contact us if you are a recruitment agency.

 

Vacancy: Junior Consultant Pharmacovigilance 32-40 hrs per week

DADA CONSULTANCY B.V. (www.dada.nl), is een toonaangevend onafhankelijk en internationaal adviesbureau op het gebied vanontwikkeling, registratie en geneesmiddelenbewaking van medicijnen (humaan en veterinair). DADA is gevestigd in een modernkantoor te Nijmegen en Gdańsk (Polen) met in totaal 36 medewerkers.

DADA is een jong en snel-groeiend bedrijf en kenmerkt zich door haar hoge kwaliteit van dienstverlening en door een open eninformele sfeer op kantoor. Je werkt in een dynamisch en enthousiast team van 16 medewerkers. Vanwege onze internationaleklanten is Engels de voertaal wat procedures en werkzaamheden betreft.

 

Ter ondersteuning van het Safety Data Management team van de Pharmacovigilance afdeling zijn wij op zoek naar een:

Junior Consultant Pharmacovigilance

(32-40 hrs per week)

 

Wat ga je doen:

Je bent werkzaam in het Safety Data Management team van de PV afdeling. Je bent verantwoordelijk voor alle werkzaamheden diedoor dit team worden uitgevoerd; in het bijzonder:

  • Verzamelen, verwerken en evalueren van veiligheidsinformatie zoals bijwerkingen en indien nodig het rapporteren aan deoverheid van deze informatie;
  • Wekelijkse literatuur screening van lokale en internationale wetenschappelijke tijdschriften;
  • Indiening van farmaceutische productinformatie in de zogenaamde XEVMPD database;
  • Beantwoorden van medische vragen van patiënten en zorgverleners zoals artsen en apothekers;
  • Verwerven en bijhouden van algemene farmacovigilantie wetgeving, zowel nationaal als internationaal;
  • Implementeren van farmacovigilantie wetgeving in het DADA PV systeem en procedures;
  • De wensen van DADAs’s klanten omzetten en uitrollen in adequate activiteiten.

Competenties/Educatie:

  • Afgeronde Master opleiding in de Life Sciences of afgeronde Bachelor opleiding in de Life Sciences met minimaal 2 jaarrelevante werkervaring;
  • Goede beheersing van het Nederlands en Engels in woord en geschrift, beheersing van Duits in geschrift is een pré;
  • Zeer goede communicatieve vaardigheden;
  • Goed in tijdmanagement, planning en prioriteiten stellen;
  • Accuraat, compliance mind-set om PV procedures uit te voeren en op te zetten;
  • Stressbestendig, kan goed omgaan met wisselende workload;
  • Teamplayer en staat open voor verandering, neemt initiatief waar mogelijk;
  • Blijft in ontwikkeling door onder andere actief te leren van werkervaringen.

Wat mag je van ons verwachten?

Een interessante, afwisselende en dynamische werkomgeving in een mooi kantoor met hartelijke collega’s. Uiteraard biedt DADA primaprimaire en secundaire arbeidsvoorwaarden. Daarnaast bieden we je ontwikkel- en doorgroeimogelijkheden binnen onze organisatie.

 

Ben je geïnteresseerd? Wij ontvangen graag je CV en motivatiebrief in het Engels.

DADA Consultancy BV

T.a.v. Steffie Dirks, Allround Staff Assistant

Godfried Bomansstraat 31

6543 JA Nijmegen

of e-mail naar office@dada.nl

 

Voor ons Privacy beleid verwijzen we je graag naar onze site:  www.dada.nl

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Vacancy: Consultant Medical Safety Physician 32-40 hrs per week

 DADA CONSULTANCY B.V. (www.dada.nl), is a leading, independent and international consultancy in the field of development, registration and pharmacovigilance of medicines (human and veterinary). DADA is located in a modern office building in Nijmegen (The Netherlands) and Gdańsk (Poland) with 36 employees in total.

DADA is a young and fast-growing company characterized by its high quality of service and by an open and informal atmosphere at the office. You will work in a dynamic and enthusiastic team of 16 employees.

We are looking to strengthen the Benefit Risk Management team of the Pharmacovigilance department with a:

Consultant Medical Safety Physician

(32 – 40 hrs per week)

What are you going to do?

 You will be working in the Benefit Risk Management team of the Pharmacovigilance department.

 As Consultant Medical Safety Physician, you are responsible for

  • Performing medical review and providing medical advice on safety-related aspects associated with the assigned products;
  • Performing signal detection and evaluation of safety for assigned products;
  • Providing appropriate and timely Benefit Risk Assessments and safety related regulatory reports for assigned products (e.g. writing PSURs, PADERs, DSURs);
  • Design, track and follow up risk management plans for the products assigned and assure their sound implementation;
  • Provide medical-related support during pharmaceutical development and registration/variation procedures;
  • Provide medical guidance for conducting Health and Safety Assessments;
  • Writing scientific advice or response documents to health authority’s clinical questions/remarks;
  • Develop and conduct pharmacovigilance and product training;
  • Answer and follow-up queries from consumers, patients, and health care professionals;
  • Implement applicable PV and clinical trial regulations for the assigned products;
  • Implement and follow-up of safety data exchange agreements for products assigned;
  • Coordination and execution of the medical analysis of adverse reaction reports and / or signal detection activities for assigned products in clinical development and after authorization;
  • Providing medical input to the PV Team with regard to safety aspects of the design and preparation of protocols, research brochures, research letters and reports, for the follow-up and processing of clinical research safety data and conduct the medical review of and safety analyses for the assigned projects.

Competencies/ Education:

  • You have a medical degree, preferably with relevant working experience in Pharmacovigilance;
  • You master the English language in speech and writing and it is a plus if you also speak Dutch;
  • You have good communication skills;
  • Drug safety evaluation and risk management knowledge and experience is preferred;
  • Understanding of the Dutch Healthcare System (and other systems in EU) would be excellent;
  • GCP certification is a plus;
  • Time management is not a problem for you! You are perfectly capable of setting your own planning and priorities;
  • You work accurately and you have a compliance mind-set to perform according to procedures;
  • You like to work in a team;
  • You are stress resistant;
  • You are open to (proposing) change and will take the initiative when necessary;
  • You continue to develop by, among other things, actively learning from work experiences;

What can you expect from us?

An interesting, varied and dynamic work environment with nice colleagues. Of course, DADA will offer you excellent primary and secondary employment conditions. We also offer you development and growth opportunities within our organization.

Are you interested? We would like to receive your CV and motivation letter in English.

DADA Consultancy BV

T.a.v. Steffie Dirks, Allround Staff Assistant

Godfried Bomansstraat 31

6543 JA Nijmegen

Or send an e-mail to office@dada.nl

For our privacy policy we kindly refer you to our site: www.dada.nl

Please do not contact us if you are a recruitment agency.

Pharmaceutical advertising and compliance

The EU regulates advertising of pharmaceutical products on a member state level. This requires expertise on a member state level.

DADA is an established service provider in the field of pharmaceutical advertising. Our dedicated and qualified team supports you in obtaining high quality and compliant pharmaceutical advertising.

DADA provides compliance review for the full spectrum of pharmaceutical advertising; written and oral promotion, patient support programmes and financial inducements. We serve innovator and generic companies, and their prescription-only and OTC pharmaceutical products.

The compliance review is conducted as per the applicable legislation and selfregulation, where necessary complemented by the EU Directive and EFPIA Code. Our consolidated network of partners allows us to coordinate projects at European level.

Quantitative Structure-Activity Relationship (QSAR) assessment according ICH-M7

DADA Consultancy carries out database and literature searches for carcinogenicity and bacterial mutagenicity data, computational toxicology assessment by two complimentary (Q)SAR prediction methodologies (one expert-rule and one statistical-based) for bacterial mutagenicity and expert analysis including read-across all according ICH-M7.

Phase 1 Environmental Risk Assessment (ERA)

DADA Consultancy carries out the Phase 1 ERA risk assessment and Phase 1 PBT (Persistent, Bioaccumulative and Toxic) risk assessment according current guidelines and helps you avoid costly Phase 2 ERA risk assessment.

Health based exposure limits (HBEL)

DADA Consultancy carries out the evaluation of all available pharmacological and toxicological data, and in concordance with ICH guidelines, constitutes a permitted daily exposure (PDE) report including a clear scientific rationale.

Derived threshold values can be used as a risk identification tool and can also be used to justify carry over limits used in cleaning validation.

Early Access programs

DADA has experience in planning and applying for Early Access Program authorisations in the BeNeLux. These programs ensure access of clinical trial participants to their successful treatment after finalisation of the clinical trial until marketing of the drug, the compassionate availability of the medicine after MA application but before commercialisation and supply on a per-named-patient basis of medicines without an MA in the concerned countries.