Drug Safety Physician till Sobi
Swedish Orphan Biovitrum AB (publ) / Läkarjobb / Stockholm
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SOBI offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals on fulfilling the high medical needs of rare disease patients and providing treatment and services to them. Our employees have their background in various fields of research, industry and the academic sphere.
We are looking for a Drug Safety Physician who will be involved in all safety surveillance activities for marketed Sobi products and for products under development. The Drug Safety Physician will be responsible for ensuring that safety surveillance activities are conducted to the highest ethical and safety quality standards in compliance with GCP and GVP and worldwide regulatory requirements.
Key Responsibilities:
Ensure ongoing evaluation of the overall safety profile for one or more assigned products, serving as the product safety expert, working in close partnership with assigned Drug Safety Manager (DSM).
Responsible for safety signal management from all sources for assigned products.
Responsible for safety surveillance in clinical studies.
Leads the Benefit Risk Team (BRT) for assigned products.
Leads risk minimization strategies for assigned products.
Provide safety related input to clinical documents and core safety information.
Provide medical safety input during the production and maintenance of Patient Risk Management Plans.
Provide safety related input to preparations for contacts with Health Authorities (HA). Takes part in key meetings at HAs if required.
Maintain knowledge of the company disease and therapeutic areas for marketed drugs and drugs in development.
Interacts with other function ( e.g. Medical Affairs, Clinical Development, Regulatory Affairs, Clinical Translational Science, Quality Assurance/ Quality Control).
Qualifications:
Education/Learning Experience/Work Experience
Required
Medical Doctor with working experience as a physician.
10 years of experience of working in the Pharmaceutical Industry or Drug Regulatory Agency, with at least +5 years of experience in Pharmacovigilance
Experience from Pharmacovigilance work for both marketed products and products under development
Desired: Experience in working at a Drug Regulatory Agency.
Skills/Knowledge/Languages
Required:
In-depth knowledge in pharmacovigilance across all key processes
Knowledge of the Pharmaceutical Industry, especially clinical research and global regulatory requirements.
Fluent in English, both written and oral.
Personal Attributes
Required
Ability to balance medical knowledge with industry standards to achieve business goals.
Service minded and ability to work collaboratively.
Reporting to: This position will be reporting into Head of Safety Science.
If you would like further information about this position please contact Josephine Ivstam
Josephine.ivstam@sobi.comPlease apply through the ad on our webpage
www.sobi.comPubliceringsdatum2019-12-10Så ansöker duSista dag att ansöka är 2020-01-09
Klicka på denna länk för att göra din ansökanAdressSwedish Orphan Biovitrum AB (Publ)
Tomtebodavägen 23 A
17165 Solna
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Swedish Orphan Biovitrum AB (Publ) (org.nr 556038-9321)
Tomtebodavägen 23 A (
visa karta)
171 65 SOLNA
Arbetsplats Sobi
Jobbnummer 4995565
Observera att sista ansökningsdag har passerat.