PV Safety Physician

RM IT Services GmbH


Job ID :

14721


Company Type :

Staffing Firms


Industry :

Medical and Nursing


Education Level :

Master of Science,Medical Doctor,phD


Address 1 :

Western Europe,--Lausanne,Lausanne,


Key Skills :

Safety Physician


Salary :

Market Rate


Date Posted :

12 Apr, 2019



Company Name :

RM IT Services GmbH


Location1 :

Lausanne




Job Category :

Clinical Monitoring Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

100.00%





Description

PV Safety Physician with knowledge in clinical trials wanted for our Lausanne based client in the pharmaceutical sector.

Your experience/skills:

* Several years of working experience as a Medical Doctor or Physician with solid knowledge of international clinical development as well as post-marketing regulations
* Familiarity with relevant regulations and concepts in data management, systems epidemiology and statistics
* Competent in handling risks and propose mitigation actions in complex and critical situations
* Higher degree in clinical pharmacology, pharmacovigilance or drug safety is additional
* Languages: fluent English both written and spoken

Your tasks:

* Reporting to the Head PV Risk Management, ensuring the benefit risk assessment is current for a specific set or product along with maintaining mitigation plans, safety analyses in aggregate reports as well as medical review of ICSR
* Providing input to Risk Management Plans (RMP), Common Technical Document (CTD) or equivalent document for Dossier Registration and label as well as to Development Safety Update Reports (DSURs) and Aggregate Reports (PSUR, PBRER)
* Providing measures targeting at minimising risks during clinical development, releasing and updating the Development Risk Management Plans (DRMPs) as well as organizing meetings for products with the Product Safety Team (PST) and Portfolio Safety Committee (PSC)
* Managing the scientific review of safety related information in CCDS and CSI, maintaining product labelling and investigator brochures, contributing answers to safety related questions from Regulatory agencies or Health Authorities and involving in Investigators/KOLs meetings as well as in due diligences
* Ensuring the safety of data review during clinical trials through Safety Plans and Safety Review Meetings along with collaborating with Strategy and Innovation Group, Clinical Development group and other stakeholders to ensure effectivity

Start: 05/2019
Duration: 04MM+
Location: Lausanne, Switzerland
Ref.Nr.: BH14301

Does this sound like an interesting and challenging opportunity to you? Then take the next step by sending us your CV as a Word document and a contact telephone number.

Due to work permit restrictions we can unfortunately only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.

Going the extra mile…

New to Switzerland? In case of successful placement, we support you with:

* All administrative questions
* Finding an apartment
* Health - and social insurance
* Work permit and much more


Company Name:

RM IT Services GmbH


Headquarters:

Hackescher Markt 2-3,


Sector:

Staffing Firms


Country:

Germany


Zipcode:

10178


Website:

www.rmgroup.ch


Employees:

100 - 499


Industry:

Pharmaceutical Recruitment


Phone No. :

+41583560693


Professional Resources, Professional Services Since its establishment in 1998, the RM Group has developed to become one of the leading companies in the field of IT Resources Management in Switzerland. As a specialised recruitment agency, we find highly qualified experts for your projects. This is the basic requisite for the targeted development of IT strategies and for the practical implementation of IT projects. The RM Group is among the few significant Swiss recruitment agencies which fulfills all requirements related to compliance and quality assurance per ISO 9001, ISO 14001, GoodPriv@cy® and EcoVadis certification.

For more information,visit www.rmgroup.ch.

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