Drug Safety Manager to Ipsen AB
Scientific Solutions Scandinavia Holding AB / Apotekarjobb / Stockholm
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hela Sverige Visa alla jobb hos Scientific Solutions Scandinavia Holding AB i Stockholm Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients' health and quality of life and providing them with effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in oncology, neurosciences and rare diseases. Ipsen commercialize more than 20 drugs in over 115 countries, with a direct commercial presence in 30 countries worldwide. The Group has about 5,800 employees worldwide.
In the Nordic countries, Ipsen is represented since 2006 with a Nordic office in Kista Science Tower outside Stockholm. In 2019, Ipsen was announced as the fastest growing pharma company in Sweden according to Läkemedelsmarknaden. Today we are about 45 employees in the Nordic region and we work mainly in the therapeutic areas of endocrinology, oncology (renal cell carcinoma, hepatocellular carcinoma, prostate cancer), neuromuscular diseases, and ultra-rare bone disorders. We also have our Baltic marketing organization, with around 20 people, belonging to the cluster.
For further information about Ipsen, please visit
www.ipsen.com and
www.ipsennordic.com The Regulatory Affairs department in the Nordic and Baltic Cluster has currently 5 employees and is expanding to 7. The primary focus for the Regulatory Affairs department is on regulatory affairs, quality assurance and pharmacovigilance. Due to the expansion we are now looking for a Drug Safety Manager to the Nordic office in Kista Science Tower, Stockholm
Scope of the role
As a Drug Safety Manager at Ipsen you will manage local pharmacovigilance activities in the Nordic countries and provide overall guidance to the Baltic countries. You will ensure that local pharmacovigilance processes are updated and inspection ready and you will be the point of contact for Global Patient Safety and for national Health Authorities. Besides that, you will provide medical information oversight and manage the Medical Information system.
Main responsibilities
Ensure that all PV activities are delivered in line with local guidelines, legislation as well as local and global Ipsen Policies and SOPs and ensure that the affiliate has a comprehensive local PV system
Ensure the accurate, timely reporting and follow-up activities of all adverse events and special situations reports and have necessary translation and quality steps in place
Ensure review of literature for collection of AEs and Safety Signals
Escalate any signals identified at local level or highlighted by local health authorities
Compile monthly metric reports and perform weekly/monthly reconciliations for adverse events, medical information and product quality complaints
Provide Pharmacovigilance oversight to local aRMMs and ensure they are managed per global and local requirements
Support the business through the provision of drug safety expertise in the review and approval of activities such as Patient Support Programs, Clinical Trials, PV clause in agreements and Patient Data Collection Systems
Perform regular review of local regulatory requirements and best practices and inform the QPPV Office of any changes to local regulations that affect the reporting of safety data and associated reports
Work with the Medical Director to ensure that medical information activities are delivered in line with local and global Ipsen Policies and SOPs
Support the medical department and brand teams with medical information, be the medical information system superuser and respond to 1st level medical requests
Provide information and updates to the medical department and brand teams on any Company Medical Information Response Standards (CMIRS's)
Act as the local Medical Information contact for Global Medical Affairs Services
Ensure that regular, documented audits of the local PV system take place
Document and track deviations from PV processes and ensuring that appropriate CAPA are developed and implemented to address issues with compliance
Partnering with local and global Training officer to develop and update training programs and present to new hires as well as annual refresher training
Coordinating and preparing for regulatory authority PV inspections and internal affiliate country office audits and supporting the development of responses to findings
Required Qualifications
Degree in Scientific discipline (Pharmacy, Chemistry, Biological Sciences) is preferred
Substantial experience in a Pharmacovigilance and/or Medical Information team with very good knowledge of Nordics local legislation and guidelines
Knowledge of regulatory affairs is preferred
Experience from an international work environment
Excellent skills in the English and Swedish language and ideally in at least one other Nordic language.
Excellent skills in Microsoft Office Suite software
Desirable personal characteristics
To succeed in this role, you should be result-oriented and have strong organizational skills with the ability to lead and prioritize projects within tight time frames. Furthermore, you should have the ability to work both independently and as a team player and have excellent interpersonal and communication skills.
Application procedure
In this recruitment Ipsen collaborate with Scientific Solutions and all questions and applications will be managed by Scientific Solutions.
To apply for this position, send in your CV and a short personal letter by email to
cv@scientificsolutions.seApply no later than Feb 7th 2020 .
For further questions, please contact Sara Gustafsson at Scientific Solutions by phone +46 709 73 17 47 or by email
sara@scientificsolutions.seScientific Solutions specialises in talent supply for Life Science companies. We focus on management and specialist roles mainly within R&D, Clinical, Regulatory, Drug Safety, Sales and Marketing.
www.scientificsolutions.sePubliceringsdatum2020-01-02Så ansöker duSista dag att ansöka är 2020-02-07
AdressScientific Solutions Scandinavia Holding AB
Färögatan 33
16451 KISTA
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Scientific Solutions Scandinavia Holding AB (org.nr 556746-8854)
Färögatan 33 (
visa karta)
164 51 KISTA
Ansökan E-post:
cv@scientificsolutions.se Arbetsplats Ipsen AB
Jobbnummer 5023429
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