Talent.com
Diese Stelle ist in deinem Land nicht verfügbar.
Pharmacovigilance Officer / EU-QPPV • (Reporting to the ChiefMedical Officer)

Pharmacovigilance Officer / EU-QPPV • (Reporting to the ChiefMedical Officer)

AiCuris Anti-infective Cures AGWuppertal, Nordrhein-Westfalen, Germany
Vor 27 Tagen
Stellenbeschreibung

Yourmission

At AiCuris, the role of thePharmacovigilance Officer is of the highest importance. Bringingbroad knowledge to the drug safety function, you are embedded intoAiCuris project teams and support drug development related to allaspects of pharmacovigilance during discovery, drug development,regulatory review and approval. One of the long-term goals of thisrole is to extend the AiCuris drug safety function towards amarketing authorization holder.

Responsibilities

  • Responsible for all drug safety aspects withindevelopment and future marketed new drugs
  • Overseeing the risk-benefit profile of all drugs underdevelopment
  • Being the contact for regulatoryagencies related to safety as well as the primary contact for PVinspections in Europe
  • Taking over EU-QPPVresponsibility as well as the Graduated Plan Officer(Stufenplanbeauftragter (m / w / d)) function at AiCuris as needed inthe future
  • Implementing and maintaining thepharmacovigilance system and establishing its system masterfile
  • Ensuring adherence to the GVP modules asdefined by the European Commission
  • Continuousobservation of the regulatory landscape and scientific literatureregarding pharmacovigilance
  • Reviewing andamending safety information within development documents
  • Responsible for writing and reviewing adverse eventnarratives and periodic reports
  • Responsiblefor standard operating procedures in pharmacovigilance, regularupdates and training adherence
  • Overseeingservice providers

Yourprofile

  • Academic degreein life science, preferably in human medicine
  • Profound medical and pharmaceutical knowledge
  • At least 5 years proven work experience in managingpharmacovigilance in the pharmaceutical industry includingregulatory drugs in development
  • Goodorganizational, communication and intercultural skills
  • Flexible, scientific working style and willingness forcontinuous education
  • Highly motivated tocontribute and work in a growing and changingorganization
  • Good knowledge of standard andspecific software (e.g., Microsoft Office and electronicpharmacovigilance software)
  • Good English (oraland written) and German (advantageous but not a primaryrequirement) language skills

    • Why us?

  • Unique corporate culture : Scientific excellence, acollaborative working environment and the passion to improve thelives of patients defines our work. With us, you can work togetherwith innovation awarded experts with the proven ability totranslate science into commercial success. You can expectdiversity, inspiration as well as trustfulcollaboration.
  • Development : We encouragepeople to grow and strongly support individual development andlearning opportunities.
  • Flexibility : Embracingflexible working accommodations we enable our people to integratebusiness into their personal life.
  • Benefits : Employer-funded pension comes along with an attractive benefitspackage.

    • Aboutus

    AiCuris is meeting the needs ofthe growing population of immunocompromised people who requireprecise therapies to effectively treat infection. Our flagshipproduct, PREVYMIS, marketed by our partner MSD, treats CMV in adefined group of transplant recipients. Our pivotal phase 3candidate Pritelivir aims to address recurrent and resistant HSVinfections in a broad population of patients with weakened immunesystems. For immunocompromised people, an otherwise manageableinfection can mean life or death. AiCuris, with its expertise andgrowing pipeline, is committed to providing therapeutic solutionsfor them now and in the future.

    Passionate aboutour mission to develop anti-infective therapeutics for patients inneed, a team of internationally recognized experts is driving ourresearch and development to improve the lives of patients. Webelieve in a culture of trust and transparency, where feedback isconsidered an opportunity to contribute to each other's personaland professional growth. We hire people who are collaborative,adaptable, communicate well, and love to learn.

    AiCuris is an employer that supports equal opportunities,diversity and inclusion. We welcome applications from peopleregardless of their national origin, skin color, religion, gender,age, marital status, disability, sexual orientation, genderidentity or other legally protected characteristics.

    J-18808-Ljbffr