Job Vacancy Details
Pharmaceutical Affairs Manager
Marketing
Canton de Vaud - Lausanne
Permanent
Updated November 6, 2008
Job Role
The Pharmaceutical Affairs Manager ensures the compliance to local regulations and our client's internal procedures of all the activities carried out locally in relation to the commercialization of our client's products in Switzerland and outside the European Community.
Key tasks
Leadership position
- Prepare, submit and maintain our clients` "pharmaceutical licences"
- Prepare with EU HQ the submission of the MA for Switzerland
- Be the official link with local competent Authorities and hospital Ethical Committees :
- Follow up the country specific regulatory environment, "intelligence survey"
- Interface with EU HQ Pharmaceutical Affairs
- Notify in advance local MoH of congresses' sponsorship
- Contribute to the Administrative work for Price & Reimbursements purposes
- Organize, validate on a pharmaceutical point of view and follow-up the submission of promotional documentation to MoH
- Be the link with the Local Swiss Distributor
Release function
- Assume the pharmaceutical responsibilities (as Qualified Pharmacist) in accordance with internal SOP, local regulations (i.e. Drug Safety, Quality assurance, etc)
- Sign internal technical agreements/Qualified Pharmacist with our client's EU offices
- Release independently the Swiss product according to the Swiss MA after the check organized by the Local Swiss distributor.
- Provide Pharmaceutical advice (QA, regulations, transportation, ?) to our client's "export" (i.e. outside the European Community) markets
- Guarantee the pharmaceutical responsibility and follow-up of "named patient case" dossier for outside countries
- Participate with EU HQ, to the check of partner qualification; follow-up
- Preparation of any "pharmaceutical dossier" requested, submission to "authorities"
- Pharmaceutical follow-up (traceability, batch recall, documentation, etc)
- Be the link with the EU QA, EU QP PV
Who we're looking for
- PharmD. (to be "responsible technique" according to Swiss regulations)
- Experience in Pharmaceutical or Biotechnology industry
- Interpersonal skills with ability to work with others as well as independently
- Knowledge of local pharmaceutical regulations and related ethic behaviors
- Ability to develop and execute action plans in an independent environment
- Understanding of price negotiation and price & reimbursement system is mandatory
- Pharmacovigilance vision is a plus
- Fluent in English both spoken and written
- Ability to make convincing oral presentations
- Computer skills
- Admin and organizational skills
- Travel required
Personal skills:
- Team player
- Commercial awareness
- Written and oral communication skills
- Ability to motivate and convince others
- Ability to work as part of a European Regulatory Affairs network
- Initiative capacity
- Sense of ethics and responsibility
- Diplomacy
- Disciplined
- Meticulous
About our client
Our client is a premier biopharmaceutical company active in the discovery, development and commercialization of life changing drug therapies for patients suffering of serious and life-threatening conditions. The company grows very rapidly in the US and Europe with its own resources. Currently we are recruiting for them a Pharmaceutical Affairs Manager.
Michael Page Contact
Job Ref: VCTE32305
Your application will be sent to Christoph Tepr.
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