Safety Data Management Specialist
Silverdal / Apotekarjobb / Sollentuna
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hela Sverige The Drug Safety Unit is responsible for a correct and precise handling and follow-up of adverse events occurring during the use of a Pfizer product.
It concerns spontaneous reports by health professionals and patients and reports coming from market research, patient programs and studies (pre and post marketing). This way, we contribute to a correct safety profile of our products.
These data are collected worldwide and used for signal detection. The results are bundled in safety reports and are made available to government, ethical committees and researchers participating to our clinical studies.
In Sollentuna, Sweden, we are currently looking for a Safety Data Management Specialist.
ROLE DESCRIPTION
Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pfizer?s products and to meet regulatory requirements.
Determination of local submission of individual and, aggregate safety reports.
RESPONSIBILITIES
• Receipt of reported adverse events and at-risk notifications. Ensure understanding and meaningfulness of the reported cases
• Verify, rank and document case-related information based on event terms; validity, seriousness, special scenarios; timelines; accuracy and consistency. Prioritize cases based on these assessments
• Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately
• Process the case information in the global database and write/edit the case narrative, in line with the completion instructions.
• Review case criteria to determine the appropriate workflow for case processing. Dispatch case within the correct timelines to a peer colleague for review.
• Determine and perform appropriate case follow-up, including generation of follow-up requests
• Liaise with key partners, locally and other stakeholders regarding safety data collection and data reconciliation
• Develop and maintain expertise and knowledge for applicable corporate and global regulations, and guidelines (e.g. GVP modules), Standard Operating Procedures and data entry conventions
• Build expertise in pharmacovigilance and related topics like non-interventional studies, compassionate use and medical need programs
• Consistently apply regulatory requirements and Pfizer policies
• Perform local submission of aggregate safety reports.
• Determine report ability of scheduled reports , ensuring adherence to regulatory requirements
• Participate, as appropriate, in local, internal and external safety activities
QUALIFICATIONS
• You obtained a bachelor Degree in medical or paramedical field or equivalent experience preferred
• Experience in a pharmaceutical environment is an asset
• You are able to work in a regulated framework
• You demonstrate good computer literacy
• You have strong administrative skills and are able to work accurate
• You are analytical though pragmatic and solution minded
• You like to work in team as well as able to work autonomously
• You are fluent in spoken and written Swedish and English
If you enjoy delivering ambitious results and seeing challenges as an opportunity for personal development this might be the position you have been looking for.
For more information and to apply with a CV and cover letter in English please go to
www.pfizercareers.com and search Job ID 1028509.
Varaktighet, arbetstid
Tillsvidare
Heltid
Publiceringsdatum2016-03-09ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2016-03-21
Ange följande referens när du ansöker: 1028509
FöretagSilverdal
AdressSilverdal
19189 Sollentuna
KontorsadressVetenskapsvägen 10
Sollentuna
Övriga kontaktuppgifterTelefonnummer: 08-55052000
Jobbnummer 2713961
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