Pharmacovigilance, Regulatory Affairs & Quality Assurance

COMPANY

Our client is an international Company leader in the worldwide distribution of pharmaceutical products.

Passion and care of health are the topics that permit the Company to grow continuously and in the meantime to improve itself.

The person they are looking for, will be in charge for

PHARMACOVIGILANCE, REGULATORY AFFAIRS & QUALITY ASSURANCE


Education, skills and competences

Technical skills

Perfect knowledge of Pharmacovigilance and Swiss Legislation regarding drugs, over-the-counter (OTC) drugs and supplements
Very good knowledge of and fluency in spoken German and English
Previous experience in the same branch (minimum 3 years)
Scientific background: Medicine, Chemistry, Biology or Pharmaceutical and Chemistry Technology Degree

Soft skills

Strong inclination towards continuous learning on the job
Organized mindset, combined with a strong innovative spirit
Remarkable analysis
Goal-oriented
Proactive
Ability to work effectively under stress


Main tasks and activities

Keep up-to-date about Swiss Pharmacovigilance requirements
Management of spontaneous warnings and strong control activities
Use of the MedDRA Dictionary
Revision and management of Pharmacovigilance Agreements for local and Corporate products 
Management, revision and draft of local OTC drugs according to the Swiss Legislation and of the Corporate OTC
Planning and draft of Pharmacovigilance documentation (e.g. PSURs, Risk Management Plan) for local products
Training about Pharmacovigilance requirements to the staff
Maintaining contact and negotiating with the Swiss Authorities (Swissmedic)
Study of the scientific and legal documents
Wide knowledge of the Company’s products
Keep up-to-date about legislative and guide lines’ changes
Obtaining Marketing Authorisations
Rough out the requirements for labelling, storage and packaging
Support to the Headquarter regarding local legislation
Management of packaging – both new and to update
Ensuring the quality standard and the observance of the term-time
Draft of documents for the batch issue
Management of return of goods and complaint from the market 


LOCATION       Ticino


 BEGINNING     January 2015

 

 Our point of view!

If you are looking for a job that gives you the possibility to concern passion, thirst of knowledge and personal satisfaction... This is THE opportunity!
 

 

07-08-2014