Global Pharmacovigilance Specialist

Mölnlycke Health Care

Global Pharmacovigilance Specialist

Mölnlycke is a world-leading medical solutions company. We design and supply solutions to enhance performance at every point of care – from the hospital to the home proven it every day. We specialize in: • Wound management: including dressings with Safetac® such as Mepitel® and Mepilex® • Preventing pressure ulcers: with Mepilex® Border used prophylactically and devices to help turn and re-position patients • Surgical solutions: including Mölnlycke trays, HiBi® antiseptics and Biogel® surgical gloves Mölnlycke was founded in 1849. Nowadays our solutions are available in around 100 countries; we’re the number one global provider of advanced wound care and single-use surgical products; and we’re Europe’s largest provider of customised trays. Our headquarters are in Gothenburg, Sweden and we have about 7,800 employees around the world. For more information, please visit: www.molnlycke.com

Are you looking for a great career and want to make your mark? Please keep on reading but don’t just take our word for it.

We’ve interviewed colleagues around the world about their jobs, the Mölnlycke unique culture and the Mölnlycke people and it is simply a great company to work for!

Could you help improve healthcare outcomes around the world?

If the answer is yes, you think just like us and then you should apply for this exciting opportunity as:

Global Pharmacovigilance Specialist

We are now recruiting a Global Pharmacovigilance Specialist to further strengthen the Global Quality Systems department. The position is placed at Mölnlycke HQ but you can be placed anywhere in Sweden and work remotely from your home office. As Global Pharmacovigilance Specialist you will contribute to the set-up and maintenance of an efficient pharmacovigilance (PV) system, compliant with regulations and company policies and procedures. You will monitor the systematic collection, documentation, reconciliation, aggregation and timely communication of drug safety information related to Mölnlycke´s medicinal products. Furthermore, you will work closely with the Global Pharmacovigilance Lead and decide on actions to be taken to ensure a compliant PV system and make assessments and contribute to decisions around existing procedures and work instructions. 

Key Accountabilities

  • Overall responsibility for ICSR management
  • Reconciliation of adverse event and medical queries
  • Monthly regulatory intelligence activities
  • Responsible for management of Medical Queries
  • Responsible for oversight of EudraVigilance/MHRA activities
  • Active member of parmacovigilance supplier audits
  • Active member of quality audits and inspections
  • Authoring of aggregated reports
  • Responsible to ensure updated Pharmacovigilance System Master File
  • Responsible for management of Safety Data Exchange Agreement
  • 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 and the safety data base
  • Responsible for ensuring validated archiving system for PV related documentation

Qualifications

  • Minimum Bachelor’s degree in a life science discipline (e.g nursing, pharmacy) or equivalent
  • Experience working with pharmacovigilance/drug safety in the pharmaceutical industry with case handling
  • Experience presenting and critically discussing safety data internally and externally
  • Good knowledge of Good Pharmacovigilance Practice
  • Great understanding of drug development processes
  • Good knowledge of EU and US pharmacovigilance regulatory requirements
  • Preferred experience as a registered user of EudraVigilance; experience from pharmacovigilance auditing and being a certified PV auditor
  • Ability to efficiently navigate in database systems and perform searches
  • Fluent in English, both verbal and written

The person we are looking for demonstrates specialist knowledge and expertise in the pharmacovigilance area and active participation in your own continuous professional development. It is important to be a supportive and an encouraging team player with the ability to build networks and to enjoy 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.

Why Mölnlycke?

This is an exciting opportunity to join Mölnlycke, a world-leading medical products and solutions company that equips healthcare professionals to achieve the best patient, clinical and economic outcomes. This is a chance to be part of an international company with friendly people and a chance to work for a fast-growing organization that empowers its people and supports them to develop their careers.

To apply

This recruitment is handled by H&P Search & Interim. Please contact us for more information. You can apply directly by uploading your resume & cover letter or send it to us by email.

We look forward to your application!

H&P Search & Interim

Karin Tomin, karin.tomin@hpsearch.se, tel 0726-013 619

Torbjörn Ströberg, torbjorn.stroberg@hpsearch.se, tel 0703-778 774

Catharina Bergold, catharina.bergold@hpsearch.se, tel 0702-179 879