Drug Safety Officer - Safety Evaluation/Data Processing

Reframe Attitude

10-09-2009 | EXPIRA LA 16-09-2009

Job expirat

RESPONSABILITATI

For one of our friend clients, a multinational generic pharmaceutical company, we are looking for dedicated professionals to join the company team in a position of Drug Safety Officer - Safety Evaluation or Drug Safety Officer - Data Processing.

I. The tasks as Drug Safety Officer - Safety Evaluation will mainly consist of preparation and submission of safety reports according to the planning schedule.
• Preparation and submission of Periodic Safety Update Reports
• Ensure updated Safety Profiles of the company substances and prepare Company Core Safety Information (CCSI) sheets
• Perform Risk Management Plan evaluations, assess if risk minimization is needed and prepare Risk Management Plans
• Preparation of Clinical Expert Statements
• Participates in the development and maintenance of an efficient and robust Pharmacovigilance system.

II. The tasks as Drug Safety Officer – Data Processing: will mainly consist of handling of all incoming individual case safety reports.
• Receives and enters safety data into our global database.
• Evaluates from a medical point of view adverse event reports.
• Reports both electronically and by other means to authorities and associated partners.
• Communicates with client companies and other partners internationally.
• Participates in the development and maintenance of an efficient and robust Pharmacovigilance system


CERINTE

Qualifications:
• University degree in Medicine or Pharmacy.
• A good level of knowledge of general medicine and pharmacology and confident usage of English medical terminology.
• Fluent in both written and spoken English.
• Good computer skills (Office-Excel, Word, PowerPoint; Internet)
• Experience with Pharmacovigilance is preferable, but not a requirement

To apply for this position you have to fulfill the following criteria:

- Working systematically, and able to focus on details and maintain consistency
- Pro-active, punctual, well organized and responsible person
- Flexible and open attitude
- You are a team player that accepts responsibility and enjoys working independently.


BENEFICII OFERITE

Offer :

The offer consist in a motivating salary package plus the opportunity to be part of a stable and exciting multinational organization.


DESCRIEREA FIRMEI

We are a dynamic and energetic recruitment company with deep roots in HR industry. From our past experience we have developed our knowledge of the market, our networks, our professionalism and the efficiency to which we added a new perspective over how we do things.