Pharmacovigilance Scientist

RM IT Services GmbH


Job ID :

11466


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc,Master of Science,phD


Address 1 :

Western Europe,--Zurich,Zürich,


Key Skills :

PV, Pharmacovigilance, Safety, Clinical trials


Salary :

Negotiable


Date Posted :

14 May, 2018



Company Name :

RM IT Services GmbH


Location1 :

Zürich




Job Category :

Scientific Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

upto 15%





Description

Pharmacovigilance Scientist wanted for our Zurich based client in the pharmaceutical sector.

Your experience/skills:

* Life science degree (BSc, MSc) and 5+ years' experience in clinical trials and postmarketing pharmacovigilance
* 3+ years' of pharmaceutical or biotechnology industry as a Pharmacovigilance specialist
* Solid investigational event and aggregate assessment/review/documentation skills and expertise in Aggregate Report preparation and review
* Working knowledge of US/EU/APAC regulations and ICH guidelines as well as experience in communicating with the FDA, EMA, and other global health authorities
* Profound working knowledge of MedDRA coding and understanding of pharmacovigilance-related information systems
* Languages: fluent English both written and spoken

Your tasks:

* Providing PV support for developmental programs, including both early and late stage development
* Backing Vaccines Safety lead for assigned products, e.g. by performing compilation, analysis and review of safety data and safety signal management for designated compounds
* Preparing PV section for clinical study protocols, SAPs, clinical study reports, and other documents developed for submission to regulatory authorities
* Developing Aggregate Reports: Co-authors Aggregate Reports (PSURs, DSURs) and contributes to the preparation of Ad Hoc Safety Reports such as Health Hazard Evaluations
* Reviewing safety data and participating in dose escalation/continuation of vaccination decisions as well as contributing to Safety Monitoring Plan/Risk Management Plan
* Performing data analysis and drafts regulatory submission documents, for license application and variation activities and for safety issues and questions from regulators

Start: ASAP
Duration: 12MM+
Location: Zurich, Switzerland
Ref.Nr.: BH12834

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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