Mölnlycke is now recruiting a Global Pharmacovigilance Specialist to further strengthen the Global Quality Systems department. The purpose of the role is to contribute to the set-up and maintenance of an efficient and compliant pharmacovigilance system aligned with the European pharmacovigilance regulations and Mölnlycke´s policies and procedures. As Global Pharmacovigilance Specialist you will work together with the Global Pharmacovigilance manager and de... Visa mer
Mölnlycke is now recruiting a Global Pharmacovigilance Specialist to further strengthen the Global Quality Systems department. The purpose of the role is to contribute to the set-up and maintenance of an efficient and compliant pharmacovigilance system aligned with the European pharmacovigilance regulations and Mölnlycke´s policies and procedures. As Global Pharmacovigilance Specialist you will work together with the Global Pharmacovigilance manager and decide on actions to be taken to ensure a compliant pharmacovigilance system. You will provide support to functional heads, QPPV and deputy as required to ensure delivery of an efficient and compliant pharmacovigilance system. You will furthermore make assessments and contribute to decisions around the status and content of existing procedures and work instructions. The position is placed at our global headquarter in Gothenburg, but you can be placed anywhere in Sweden and work remotely from your home office.
Key Job Accountabilities
End to end responsibility for ICSR management
Responsible for QC of adverse event and medical queries
Responsible for Monthly Regulatory intelligence activities
Responsible for management of Medical Queries
Responsible for EudraVigilance/ MHRA activities
Responsible for literature screening
Active member of Pharmacovigilance audits
Active member of Quality audits and inspections
Responsible for authoring and submission of aggregated reports
Responsible to ensure accuracy of the Pharmacovigilance System Master File
Responsible for defining and documenting policies, procedures and work instructions within pharmacovigilance
Communication with competent authorities
Have oversight of and be able to manage Adverse Events in the Complaints Management System, MHC safety data base, Eudravigilance and MHRA portal
Responsible for ensuring validated archiving system for pharmacovigilance related documentation
What you’ll need
Minimum BSc’s degree in a life science discipline (e.g nursing, pharmacy) or equivalent
Experience working with pharmacovigilance/ drug safety in the pharma industry
Good knowledge of Good Pharmacovigilance Practice
Good knowledge in drug development processes
Good knowledge of regulatory guidelines
Good knowledge of pharmaceutical literature screening
Good knowledge of EU and US pharmacovigilance regulatory requirements
Good knowledge in MedDRA coding
Ability to present and critically discuss safety data in both internal and external discussions
Preferred experience as a registered user of EudraVigilance; experience from pharmacovigilance auditing and being a certified pharmacovigilance auditor
Ability to navigate in databases and pull information correctly
Fluent in English
The person we are looking for demonstrates specialist knowledge and expertise in the pharmacovigilance area and that you take an active participation in your own continuous professional development. You are a supportive and an encouraging team player that enjoys working in a cross-functional environment. You are self-motivated and able to prioritize and plan effectively and independently. Furthermore, it is of important that you have good organizational skills and an attention to detail. You enjoy being in a context where you can share your expertise and make a real impact.
What you’ll get
Competitive compensation package including company pension plan, bonus, company health care
Wellness benefits
Flexible working hours and flexible work from home policy
Great colleagues in a global company
An open, friendly and fair working atmosphere
Your work-life balance
We have a flexible work from home policy. This is a full-time position with limited travelling. However, the role requires that you will have the possibility to travel on occasion to Mölnlycke HQ if based elsewhere in Sweden.
Our approach to diversity and inclusion
We strive to have a diverse mix of people from different cultures, ages, geographies and genders, to reflect the world in which we operate and to facilitate innovative thinking across the business.
To apply
This recruitment is handled by H&P Search & Interim AB. Please contact us for more information.
We look forward to your application!
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