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.
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.
- 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
- 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.
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 firstname.lastname@example.org
Apply 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 email@example.com
Scientific 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.se