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CV de International Clinical Research Associate/ Safety Monitoring / DRUG SAFETY, cherche un emploi de CDI / social.enligne-be.com

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International Clinical Research Associate/ Looking for proposal as DRUG SAFETY/ MEDICAL INFORMATION/ MANAGEMENT BENEFIT-RISK.

Code CV : 5903c611df151ba6
Date de dernière connexion : 2017-05-28

Mademoiselle Mo... P...
....
75011 Paris
France




Situation actuelle:
Secteur d'activité actuel : Clinical Research
Taille de l'entreprise : 101 à 1000 salariés
Fonction actuelle : International Clinical Research Associate/ Safety Monitoring
Nombre d'années à ce poste : 3 à 5 ans
Nombre de personnes sous mes ordres : 21 à 50 personnes
Salaire annuel : 40.00 EUR
Expérience Totale : 1 à 2 ans
Disponibilité : Disponibilité immédiate

Poste recherché:
Fonctions: DRUG SAFETY, MEDICAL INFORMATION,
Secteur d'activité: PHARMACOVIGILANCE/ PHARMACOEPIDEMIOLOGY, REGULATORY AFFAIRS, CLINICAL RESEARCH

Type de contrat souhaité: CDI, CDD
Temps de travail souhaité: Temps plein, Temps partiel, En alternance
Salaire Annuel Minimum / Souhaité: 42.00 / 0.00 EUR

Etudes :
Dernier niveau d'etudes validé avec diplome : Bac+5
Dernier diplome : Postgraduate Diplôme Pharmacovigilance and Pharmacoepidemiology (EUROPEAN PROGRAM PHARMACOVIGILANCE AND PHARMACOEPIDEMIOLOGY)
Niveau d'études actuel : Bac+5
Autres Formations :


Mobilité :
Pays : Belgique, France, Suisse

Outils / Logiciels / Méthodes maitrisés
Medical Information and communications skills Medical and pharmacological terminology (Argus, Medra, Who Art.) Scientific knowledge/ Drug Safety knowledge Good knowledge of MS Office (good IT skills) Knowledge of Drug Safety relevant regulations (ICH, EMA and local Health Authorities).

Permis VL, PL, véhicules spéciaux
A

Langues
Italien : Langue maternelle
Français : Langue de travail
Anglais : Langue de travail
Espagnol : Intermédiaire


CV :

Mademoiselle Mo... P
75011 Paris
France


DRUG SAFETY/ INTERNATIONAL CLINICAL RESEARCH ASSOCIATE

Nationality: Italian
Date of Birth: 21/04/1984
33 Years



Skills
regarding: Pharmacoepidemiology, Pharmacovigilance, Clinical Research.
Experience in Neurosciences, Psychiatry, Psychopharmacology, Oncology,
Cardiology, Ophthalmology, Dermatology.


Knowledge:
Clinical Research
Medical Information and communications skills
Medical and pharmacological terminology
(Argus, Medra, Who Art.)
Scientific knowledge/ Drug Safety
knowledge
Good knowledge of MS Office (good
IT skills)
Knowledge of Drug Safety relevant
regulations (ICH, EMA and local Health Authorities).



Organization and planning skills:
Communication skills: (Italian,
French, English)
Proven ability to interact well
in a multifunctional team setting
Ability to work
in a highly regulated environment



Languages
Skills:
Italian
(Bilingue, mother tongue)
French
(bilingue or advanced)
English
(Advanced)
Spanish
(Intermediate)



Educational
and Professional Background:
Since 09/15 to 01/2017. EUROPEAN PROGRAM
PHARMACOVIGILANCE AND PHARMACOEPIDEMIOLOGY.
Development of a “Drug
Safety Utilization Study concerning the Drug Utilization of ACHEI and Memantine
in patients with Alzheimer Disease, residing in Italy”. This Project was
realized in collaboration with the University Autonoma of Barcellona (Pharmacology),
the Superior Health Autority (ISS) Roma. Clinical data were collected thought a collaboration with a center (ASP 9 Trapani), Sicily, Italy.
Main
activities:
Safety review of the litterature:
Global and local literature review for Drugs

Adverse event reporting plan writing

Literature search plan writing/Detection and reporting of possible safety
signals
Since
01/15: International Clinical Research
Associate ASCOPHARM Gr. NOVASCO, 56 rue de Londres, 75008 Paris.
Typical Monitoring activities:
Monitoring for a Non-Interventional Prospective
Study ( phase 4) to assess the Safety
Profile of HERceptin subcutaneus initiated in patients with HER2-positive Early
Breast Cancer. HERmione. Laboratoire Roche.
Principal activities performed concerning this
study:
Training in Pharmacovigilance (Laboratory Roche H.) for the management of AE/ Sae.
I was responsible for Management of safety queries and others significant safety information.
Information
sharing with other departments, e.g. Global Drug Safety, Medical Information, Medical
Affairs.
-Maintenance local
safety quality management system.
-Initiation visits (30 centers in Paris).
-Monitoring/ Processing and follow-up of Serious
Adverse Events.
-Management of centers in accordance with the
Protocol, ICH-GCP guidelines and local SOPs.
-Request follow-up of queries
-Register,
monitor and respond to scientific questions of doctors, pharmacists or patients
on all
-Roche products to provide the customer timely
with accurate information.



-Others
Monitoring-Safety activities were focused on Gynecology (oncology), Dermatology
and Ophthalmology. I worked in the studies with phase 2-3, I was responsible
for SIV, monitoring, and close out visits, in Italy and in France, concerning
about 30 sites in France and Italy.
-From September 2014 to December
2015: Internship as International
Clinical Research Associate (CERC,
Paris. Center of Research on Cardiovascular Diseases):
Participation to the Management of the Adverse
Events with the Clinical Research Study Staff.

Collaboration for the Submission to the Ethics
Committee.



Educational
details:
2015-2017:European Program in
Pharmacovigilance and Pharmacoepidemiology. University of Bordeaux (Post graduate Diploma, Master Year
1).
2014-2015: SUPSANTE. INSEEC. Professional
Training in Clinical Research.
2011-2012: MASTER + 5 Neurosciences and Neuropsycology. University Pierre and Marie Curie. Paris



Languages Skills:
Italian (bilingue,
mother tongue)
French
(bilingue or Advanced)
English (advanced)
Spanish (intermediate)


Lettre de candidature

Mademoiselle Mo... P
75011 Paris
France

International Clinical Research Associate/ Looking for proposal as DRUG SAFETY/ MEDICAL INFORMATION/ MANAGEMENT BENEFIT-RISK.


Dear Hiring Manager,



I am writing this cover letter, because I’m
looking for a Drug Safety Job, but I’m
also opened to other proposal in the related to the Pharmacovigilance, as Regulatory
Affairs, Clinical Research Management, and Medicine-Benefit Risk.



I have a scientific background ( Bac + 5 obtained in 2010),
a professional training in Clinical Research ( 2014), and I’m going to obtain
my post graduate diploma MSc, in Pharmacovigilance and Pharmacoepidemiology (
EU2P, University of Bordeaux).



My professional and educational experience as International Clinical Research
Associate/ Safety Monitoring allowed me
to acquired ability to work in clinical
research and also in drug safety field to make sure all medical assessments and
reviews are reported appropriately. I have good knowledge of safety process, and regulatory
affairs, and concerning medical
terminology, software used in managing large databases.



I have the skills and training needed to monitor and
keep track of all mild to serious adverse drug reactions associated with
marketed products and with any compounds considered for public use.



I have the interpersonal skills to work well as part
of a team and the motivation to work independently. I have exceptional research
skills with the ability to collect all data surrounding the adverse effects of
drugs from various clinical studies, trials and cases.



I have the ability to stay updated on all new safety
guidelines and to adhere to the FDA and International rules and regulations at
all times. I have the ability to adapt quickly to a changing environment and to
switch priorities when necessary. I also have excellent time management and
organizational skills needed to manage large amounts of data.


Kindly Regards,









Mademoiselle Mo... P...


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