εργαστείτε μαζί μας

Η Creative Pharma & HR Services S.M.S.A. είναι ένας κατ’ Ανάθεση Οργανισμός Έρευνας προσανατολισμένος στον πελάτη, που προσφέρει υπηρεσίες στη βιομηχανία φαρμακευτικών προϊόντων, βιοτεχνολογίας και ιατρικών συσκευών. Η αποστολή μας είναι να καλύψουμε τις ανάγκες των πελατών διατηρώντας παράλληλα αυστηρή εμπιστευτικότητα και επαγγελματισμό.

Η ποιότητα των ανθρώπων μας είναι ο ακρογωνιαίος λίθος της Creative Pharma Services. Η Ομάδα μας αποτελείται από παθιασμένους, προσανατολισμένους στα αποτελέσματα, καινοτόμους, ενθουσιώδεις και με εξαιρετικό ακαδημαϊκό υπόβαθρο ανθρώπους και αυτό είναι το μεγαλύτερο μας πλεονέκτημα. Λόγω της συνεχούς ανάπτυξής μας, αυτήν τη στιγμή αναζητούμε τις ακόλουθες θέσεις.

Εάν σας ενδιαφέρει, παρακαλούμε στείλτε μας το βιογραφικό σας στο: career@creativephs.com

Main Responsibilities

The Medical Manager is responsible for coordinating operational aspects of the medical department services, providing medical expertise and advice to department staff, coordinating all the activities pertinent to the medical department and ensuring the timely delivery of high quality deliverables according to standard operating procedures, pertinent legislation, and applicable regulatory requirements. The Medical Manager is also responsible for coordinating electronic data management projects as well as medical statistics projects related to data analysis, study reports or relevant medical writing projects involving medical statistics.

The role in brief:

  • Perform overall management of medical department activities.
  • Liaise with the Head of Medical to build a strong team that can effectively handle activities of the medical department and adopt to the new challenges.
  • Develop, review and oversee study protocols, protocol amendments, Informed Consent Forms, CRFs, study manuals, monitoring plans and CRF guidelines.
  • Collaborate with and provide medical/ clinical research input to the Data Manager (DM)/ Medical Statistician (MS) for the development of Data Management Plan and Statistical Analysis Plan.
  • Maintain and develop strong relationships with Key Opinion Leaders.
  • Compile scientific and clinical research information for the purposes of medical writing such as education material, abstracts, posters and manuscripts for publication purposes and assist/ advise the client of the submission/ review procedures of such manuscripts.
  • Attend and provide input to external meetings, advisory boards and symposia.
  • Represent the Company via presentations to groups of experts, societies, regulatory bodies and health authorities.
Requirements
  • Medical Degree or PhD degree in health sciences is a pre-requisite.
  • Previous professional experience in Medical Affairs (minimum 4 years) is a pre-requisite.
  • Strong ability to lead and overview project teams.
  • Ability to plan, prioritize and overview projects.
  • Problem solving and decision-making skills.
  • Strong communication and presentation skills.
  • Strong time management skills
  • Strategic thinking.
  • Results-oriented attitude.
  • Fluency in English.
  • Computer literacy.
What is offered

Creative Pharma & HR Services is offering a competitive remuneration package according the Industry’s standards. Nonetheless, we are also proud at Creative Pharma & HR Services that we are an open and learning organization that fosters a collaborative, enthusiastic, fast paced working environment, and for that reason we invest in people’s potential and growth.

By sending your CV to us you accept our “Privacy Statement and Terms for submitting your Curriculum Vitae”.

Main Responsibilities

The job holder will be responsible for the administration and coordination of all activities related with the aspects of study start up routine and furthermore the support of the Clinical Study team.

More specifically:

  • Provide administrative support to the Project team in accordance with ICH, GCPs and respective SOPs.
  • Collection and preparation of essential documents.
  • Contact with investigative sites during site start-up activities.
  • Working with investigative sites to collect the required investigator and regulatory documents for a study.
  • Prepare submission packages for Local and/ or Central IRB /IEC and Regulatory Authorities.
Requirements
  • A Bachelor’s Degree in Health Sciences or Business Administration.
  • Minimum 2 years of professional experience in a Clinical department as a Start Up Specialist.
  • Knowledge of contract handling and clinical terminology.
  • Familiarity with ICH-GCP guidelines.
  • Technology savvy and pc literacy is a must
  • Fluency in written and oral English
  • Essential personality attributes: multi-tasker with the ability to prioritize, ability to work in a fast-paced team, attention to detail, ability to handle pressure and tight deadlines.
What we offer

Creative Pharma & HR Services is offering a competitive remuneration package according the Industry’s standards. Nonetheless, we are also proud at Creative Pharma & HR Services that we are an open and learning organization that fosters a collaborative, enthusiastic, fast paced working environment, and for that reason we invest in people’s potential and growth.

By sending your CV to us you accept our “Privacy Statement and Terms for submitting your Curriculum Vitae”.

Main Responsibilities

The position lies within the Pharmacovigilance Department and general duties include:

  • Supports the Pharmacovigilance Manager in the performance of drug safety related duties
  • Records, screens and categorises reports of adverse drug reactions in post marketing environment and clinical studies
  • Coordinates tracking and evaluation of adverse drug reaction reports
  • Compiles and submits reports on cases of suspected adverse drug reactions to authorities in accordance with applicable regulations
  • Manages case-related information including interpretation of medical conditions, lab results, and procedures as well as compile complete narrative summaries; and ensure proper coding (MedDRA) into the global safety database
  • Reports adverse events to internal sources and external regulatory authorities
  • Screens local literature for expediting safety reports
  • Generate documentation required for regulatory authorities
  • Responds to inquiries from health care professionals, consumers, and company personnel regarding safety issues with marketed products
  • Prepares periodic reports, aggregate safety reports, and safety analyses
  • Provides drug safety guidance and training to our clients’ employees
  • Ensures adherence to SOPs and other process documents
  • Maintains and uses Pharmacovigilance Database and other relevant data collection tools
  • Ensure procedures in relation to safety monitoring are being adhered to regulatory requirements
Requirements
  • Life sciences background with minimum 1 year of relevant professional experience in drug safety
  • A thorough understanding of the global PV regulatory environment with working knowledge of ICH guidelines, EMA/CHMP regulations and guidelines, and other international regulatory requirements, a working understanding of drug safety databases
  • PC literate and fluent in English
  • Excellent written and verbal communication skills
  • Ability to work effectively as an individual contributor and as a project team member
  • Ability to manage multiple and varied tasks and prioritize workload with attention to detail
  • Willingness to work in a matrix environment and to value the importance of teamwork
What we offer

Creative Pharma & HR Services is offering a competitive remuneration package according the Industry’s standards. Nonetheless, we are also proud at Creative Pharma & HR Services that we are an open and learning organization that fosters a collaborative, enthusiastic, fast paced working environment, and for that reason we invest in people’s potential and growth.

By sending your CV to us you accept our “Privacy Statement and Terms for submitting your Curriculum Vitae”.

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