Drug Safety Associate
Poolia Life Science & Engineering AB / Apotekarjobb / Solna
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Visa alla apotekarjobb i Solna,
Sundbyberg,
Stockholm,
Danderyd,
Lidingö eller i
hela Sverige Visa alla jobb hos Poolia Life Science & Engineering AB i Solna,
Sundbyberg,
Stockholm,
Lidingö,
Järfälla eller i
hela Sverige We are now looking for a Drug Safety Associate for a temporary assignment at one of our customers in Solna.
The assignment which is full-time will start 21 Mars 2016 with the duration to 31 December 2016, with possible extension. Selections and interviews are held on an ongoing basis, so please submit your application as soon as possible.
Position Summary
• Support Nordic Consumer and Pharma Drug Safety Manager in order to be compliant with current Standard Operating Procedures (SOPs) and regulations.
• Processing and report Individual Case Safety Reports (ICSRs) within McNeil Sweden AB, including Sweden, Denmark, Norway and Iceland, to the global safety group Office of Consumer Medical Safety (OCMS) for further reporting to regulatory authorities.
• Support the establishment and maintenance of processes for storing, archiving, and retrieving ICSRs
Principal Responsibilities
• Drug safety associate is responsible for the initial safety assessment at case entry of all products in the LOC (medicinals, cosmetics and devices)
• Case management
• Receive and process AE cases from spontaneous (e.g. Swedish and Danish Medical Information, Health Care Professionals (HCP), patients, consumers or other relevant sources), regulatory and solicited sources.
• Report Serious Adverse Events (SAE) from pregnancy, spontaneous, regulatory and solicited sources.
• Accurately report and follow-up AE information to OCMS through the IRT (Inbound Receipt Triage) database according to accurate timelines.
• Support in monthly reconciliation with OCMS, Medical Information (weekly), Product Quality Complaints and other relevant sources.
• Weekly and daily Quality Control for SUE on cosmetic products
• Support in collection and compiling of compliance on PSUR submission for aggregated reports.
• Providing safety information to Health Care Professional (HCP) and consumers.
Support Nordic Drug Safety Manager in following areas:
• Stay compliant with Johnson & Johnson Consumer Nordic policies and SOPs, applicable GMS/OCMS SOPs, as well as national and international Pharmacovigilance regulations.
• Develop and ensure adherence to AE reporting procedures and guidelines.
• Compliance.
• Maintain and oversee the maintenance and archiving of AE report case files.
• Review Market Research material for any questions that might generate AE reports.
• Conduct Pharmacovigilance training to employees of McNeil Sweden AB, McNeil Denmark ApS, McNeil Norway A/S including contractors and relevant third parties.
• Maintain expertise and current awareness in the field of Pharmacovigilance.
• In cooperation with Medical Information and Consumer Care employees guarantee that internal and external questions regarding adverse reactions are handled in an optimal way.
• Keep the Cross Sector Country Safety Lead informed and updated on the progress of all important aspects within the field of Pharmacovigilance.
• Provide support to business (e.g. Medical, Marketing, Sales).
• Collaboration with a diverse group of individuals both externally (e.g. healthcare professionals, caregivers, patients, consumers) and internally (e.g. regulatory, medical, sales, marketing, OCMS/GMS).
• Interacts with other Drug Safety employees for collaboration, consultation, and sharing of best practices.
• Regular collaboration with external networks is encouraged.
Decision-Making And Problem-Solving: AE assessments, seriousness assessments, medical device reportability based on applicable SOPs and regulations
Working Relationships/Interfaces:
Peers in Cross Sector PV team for daily work.
Consumer Care – Call center for devices and cosmetic, logging of PQCs and AEs, reconciliation, QC, Quality investigation of combined cases
Professional Information (ProPharma) – case reporting, reconciliation, QC
OCMS/GMS for case processing, set-up of queries, reconciliation, oversight
QPPV office – requests for information for PSMF
Global Strategic Insights (GSI) – Market Research activities
HIVE Hub – Market Research activitites
Marketing Northern Europe – Promotional activities
Commercial Organizations in SE, DK, NO – Promotional activites, shopper reserach
Vistor Iceland – distributor in Iceland, forwarding of cases, reconciliation
Regulatory Affairs – Aggregate reports submission, CCDS, SPC updates
Quality Affairs – SOP control, recalls, audits
Qualifications:
• Scientific/medical background, like biomedicine, pharmacy, or similar
• Preferably some working experience in Pharmacovigilance
• Preferably Finnish speaking
Benefits
We take good care of our consultants and we offer social activities, as well as help in planning your future career. Your consultant manager is well experienced from your field, and knows how to get the most out of your assignment. As a Poolia employee, you are included in the requirements concerning agreements on terms of employment by Unionen. Moreover, you get a grant for working out at your choice of place. You are also covered by a health insurance.
Varaktighet, arbetstid
100 %. Tillträde: 2016-03-21 Visstidsanställning
Publiceringsdatum2016-03-03ErsättningMånadslön
Så ansöker duSista dag att ansöka är 2016-03-07
Ange följande referens när du ansöker: 661349
Klicka på denna länk för att göra din ansökanKontaktJoakim Karlsson
joakim.karlsson@poolia.seFöretagPoolia Life Science & Engineering AB
AdressPoolia Life Science & Engineering AB
Kungsgatan 57 A, Box 207
10124 Stockholm
KontorsadressKungsgatan 57 A, Box 207
Jobbnummer 2705371
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