EQL Pharma is an entrepreneurial pharmaceutical company focusing on simplicity and efficiency at all levels of the value chain to be able to deliver a large portfolio of niche pharmaceuticals and niche originals to pharmacies and hospitals, primarily in the Nordic region.
As niche generics are not normally available for purchase, or license, as fully developed products, EQL Pharma conducts extensive development work on these in close collaboration with partners in Europe, India and China. The entry barrier for potential competitors is therefore significantly higher for these niche generics than for regular generics, as these niche products are EQL Pharma’s own products.
The strategy is to build a large portfolio of niche generic medicines and niche originals in areas where the competition is limited. EQL Pharma does not focus on specific therapeutic areas, but rather on the opportunities identified in the Nordic market for prescription medicines sold in pharmacies or used in hospitals. The entire business is based on delivering the cheapest medicines to pharmacies and hospitals, in this way daily lowering the cost of high-quality drugs for patients and society.
EQL Pharma has built a strong network of partners both in the life science cluster Medicon Valley and in the rest of Europe and the world, a network that is in constant growth and refinement as new ideas and opportunities take shape. During the last years the company has had a strong growth. Robust financing and well-thought-out analyzes are behind every investment the company makes both in its pipeline and in the expansion into new markets. Today, EQL Pharma has a signed pipeline of approximately 50 products and an extensive funnel of in-licensing and developmental product candidates.
EQL Pharma was founded in 2006 and is listed since 2014. The company is based in Lund, Sweden and employs around 23 people. The company strives to attract and retain personnel with excellence in all areas relevant to the company. High level of education, solid proven experience and personal commitment characterize the company's staff today.
Last year EQL Pharma was certified as “Great Place to work”.
For more information about EQL Pharma, see the homepage, http://www.eqlpharma.com
TILLSATT - Regulatory Affairs / Pharmacovigilance Manager
Company: EQL Pharma AB
Position: Regulatory Affairs / Pharmacovigilance Manager
Reports to: Director Regulatory Affairs, Quality Assurance and Pharmacovigilance
Location: Office in Lund/Remote/Hybrid
EQL Pharma is looking for a Regulatory Affairs/Pharmacovigilance Manager who will be responsible for ensuring that regulatory activities are effectively executed, to meet the business objectives and legal requirements. You will also act as internal PV contact person responsible for EQL’s compliance with PV requirements in the role as MAH.
This is a broad role in an entrepreneurial company for someone who is willing to contribute with own knowledge and experience and at the same time to develop and learn new things. The ideal candidate has previous experience from the pharmaceutical industry, from both a regulatory affairs perspective as well as pharmacovigilance. However, most important is that you are interested in working within both areas.
You should have an understanding and demonstrated ability to apply regulatory guidelines / regulations to successful dossier preparations, submission, and maintenance. The candidate will provide project management and interact with important internal and external stakeholders and regulatory authorities.
The focus of the PV responsibility is to deliver prompt and qualitative side effect reporting and other PV related tasks required by regulatory oversight authorities, internal policies and SOPs that contribute to patient safety.
The role includes cooperation with India, Indonesia, and several different European countries – an interest and understanding for different cultures is required. Therefore, it is important that you are social and good at working with other people.
The right candidate is able to work independently and take ownership of tasks. As the company is small, you must have a “can do” attitude and be comfortable in situations where you are hands-on. You have a flexible and prestigeless personality, and enjoy working in a small, quickly growing company with short decision paths and where many things are going on at the same time
This is an opportunity to join the fastest growing niche generics company in the Nordics. You will join a group of 5 people (RA and QA) and report to the Director Regulatory Affairs, Quality Assurance and Pharmacovigilance.
Responsibilities and main tasks
Regulatory Affairs - Life Cycle Management
• Manage and oversee all relevant maintenance activities including Life Cycle Management
• Liaise and negotiate with regulatory authorities
• Creation of variation and renewal applications to competent authorities in the Nordics and other European countries
• Submission of variation and renewal applications through the national procedure and DCP/MRP
• Ensure that quality standards are met and that the deliverables meet strict deadlines and fulfil European regulatory and quality standards
• Assess change control case from CMOs and decide on impact on dossier/required actions
• Responsible for product information (create/update SmPC/PILs, translations) and artworks for EQL Pharma´s products in EQL´s territory. Write comprehensible, user-friendly, clear product information leaflets and labels.
• Coordinate and act as contact person in out-licensing projects (coordinating due diligence from other parties, responding to questions, participating in cross functional meetings)
• Contribute to creation and improvement of internal RA processes and working instructions
• Use a variety of specialist computer applications
• Acting as internal contact person responsible for PV at EQL Pharma
• Ensure that all EQL Pharma´s PV requirements in the role of MAH are complied with
• Ensure that systems are in place for timely submission of information from EQL to QPPV/dQPPV and from PV service provider to EQL Pharma
• Ensure that necessary processes (SOPs, Working Instructions) for EQL Pharma´s PV activities are in place and maintained
• Ensure that the PSMF is continuously updated
• Ensure that new employees/consultants receive PV introduction training and that annual PV refresher training for all EQL employees is performed
• Coordinate external and internal audits and participate in PV inspections from MPA (including preparations, creation of CAPA plan and follow up on implementation of results)
• Establish and maintenance of Pharmacovigilance Agreements/Safety Data Exchange Agreement with all relevant Suppliers and PV Service providers
• Perform Risk Assessments and qualification of Suppliers/PV Service Providers and ensure that there is an updated Audit Plan in place
• Documentation, assessment, investigation, creation of CAPAs and follow up of deviations within the PV area
• Degree within pharmacy or life-science
• A few years of experience within RA - including classification and compilation of variation application packages and renewals
• A few years of experience within Pharmacovigilance
• Experience in eCTD is a big advantage
• Fluent in Swedish (or other Nordic language) and English
• IT skills
• Adapts to the team and builds team spirit, listens, consults others and communicates proactively
• Gathers comprehensive information to support decision making, manages knowledge (collects, classifies and disseminates knowledge of use to the organisation)
• Strong initiation and organizational skills
• Adapts to changing circumstances
• Strong analytical skill and technical/ scientific competence
Opportunities with the role
EQL Pharma is in a fast growth and the company strives to give all employees a great deal of individual responsibility for their work and their work situation. This includes a great opportunity to influence and take initiatives within one's own area of responsibility, but also within other adjacent areas that may be valuable for EQL Pharma.
This is an opportunity to work in a key role with a broad spectrum of responsibilities in a small listed pharmaceutical company and to contribute to the growth of the company. The vision is to build the largest niche generics portfolio in the Nordic countries, where the regulatory function plays a crucial role in this development.
The work is with international focus and performed in close cooperation with several international development partners and licensing partners. Since the company focuses on “first-in-class generic” products, responsibilities include different therapy areas, compilation of full registration files, and direct contact with authorities, in the Nordic countries and elsewhere in Europe. The position also includes project management and international travelling.
Contact & Application
For inquires and more information about the position, please contact:
Catharina Herbertsson or Eva Runnerström, Senior Recruitment consultants at PeakSearch.
M: +46 706 152 772
M: +46 701 725 379
Apply for the position at PeakSearch homepage http://www.peaksearch.se or send your cover letter together with your CV directly to either Catharina or Eva, e-mail see above.