Contract Pharmacovigilance Medical Affairs Special job in Croydon, South East

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Job Title		Contract Pharmacovigilance Medical Affairs Special

Posted		04/01/2010 (11:19)

Agency/Employer		Quality Start

Description		Contract Pharmacovigilance Medical Affairs Specialist - Croydon Opportunity: Your role as a Pharmacovigilance Medical Affairs Specialist will involve ensuring compliance in all medical affairs activities and ensure correct and safe use of all products and ethically maximize growth opportunities. Duties include: � Writing Summary of Product Characteristics (SMPC�s) and patient information leaflets (PIL�s). � Work closely with the Regulatory Affairs to support their needs for documentations to register the products. � Answer queries from the Health Authorities related to products marketed by the Company and support the necessary submissions with an appropriate data. � Revise through updating SMPC�s and PIL�s the scientific documents for the products marketed by the Company, such as summary product characteristics (SPC), patient information leaflet/literature (PIL) etc. in compliance with: o The guidance from the Clinical Expert Statement (CES) from Periodic Safety Update Reports (PSUR) received from pharmacovigilance partner and o Approvals from Regulatory Agencies, as information received from the Regulatory Dept. o Harmonize SPC/PIL for different countries (e.g. UK/Ireland), as per the regulatory requirements/variation. � Update PIL for user testing under the guidance of Head Medical Affairs and offer necessary assistance to the business units during user testing. � Prepare and update abbreviated prescribing information, whenever necessary and appropriate. � Review and sign off prepared Clinical Overview Addenda. This is initially a 6 months contract which could get extended or go permanent. Skills: In order to apply for the Pharmacovigilance Medical Affairs Specialist role you will have the following skills: � Medical degree. � 2-3 years of experience in the Medical affairs and Pharmacovigilance function of a UK Pharmaceutical Company. � MHRA submissions experience. How to Apply: If this sounds like the role for you or a colleague then please don�t hesitate to contact us. Quality Start will offer �200 to anyone who successfully recommends a candidate who is subsequently employed by our client. To apply for this one of opportunity, please send your CV to me now or call for a confidential chat. For a list of our current vacancies, please visit our website. If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role. Quality Start are acting as a specialist recruitment consultancy for this role.

Location		Croydon, South East

Job type		Contract

Contract length		6 Months Contract

Salary/rate		�40000 - �49000/annum

Start date		ASAP



Contact name		Rashida Khan

Job Reference		QS0188

Job ID		120173173

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