Chargé de Pharmacovigilance: travaillez en maison mère

Jan 04, 2021
Feb 03, 2021
Michael van Hooft
Jobseeker Type
Organization Type
Contract Type
Full Time

Pour un laboratoire confirmé et fascinant avec divers projets notamment en maladies rares, nous recherchons un Chargé de Pharmacovigilance expérimenté.

Les activités du chargé de PV se répartissent comme suit (en anglais) :

1. Draft the following documents :
* Individual Case Safety Reports (ICSR)
* Periodic Safety Update Reports (PSUR)
* Ad hoc Safety Reports
* Patient Follow-up Reports for registered or unregistered products (such as named-patient use)
* Annual safety reports on clinical trials

2. Participate in the drafting of the safety sections of the following documents:
* Clinical Study Protocols and Case Record Forms
* Summary of Product Characteristics (SmPC)

3. Participate in drafting new/revised Standard Operating Procedures (SOP)

1. Participate in the collection of all information related to individual Adverse Event (AE) cases :
* from Health Care Professionals (HCP) and/or patients
* from OE subsidiaries and Other Territories
* from CRAs and Medical Department's physicians

2. Operate the OE Safety Database (ORIAM ES1-Manager)
* Ensure data entry of individual cases using MedDRA dictionary
* Ensure electronic expedited reporting to the relevant authorities
* Edit individual cases and line listing for periodic reporting and ad hoc safety reports

3. Answer requests for pharmacovigilance from HCP or OE subsidiaries

1. Ensure the proper follow-up of individual cases until their completion
2. Ensure timely follow-up of the company's commitments to Health Authorities


- Médecin ou Pharmacien de formation

- Au moins 5 années d'expérience en PV (idéalement 7-8 années ou plus)

- Expérience spécifiquement dans un contexte d'activités de maison mère

- Anglais courant requis

- Habitant ou souhaitant habiter Paris


- Salaire très compétitif

- Possibilités d'évolution

- Travaillez dans un grand laboratoire de renommé

Vous êtes intéressé? Contactez-moi avec un CV à jour pour en discuter plus amplement:

- Michael van Hooft

- +33 1 76 75 33 40 extension 3147


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