Global Pharmacovigilance Lead

Does helping to make life better for millions of people motivate you?
If the answer is yes, you think just like us. We are a world-leading medical solutions company, designing and supplying medical solutions to enhance performance in healthcare – from the hospital to the home.
We’re looking for people who want to improve outcomes for healthcare professionals and their patients.
Continuing to invest in our future, we are hiring a Global Pharmacovigilance Lead, to be based in our Gothenburg HQ.
We are primarily a Medical Device company, however certain of our products such as the market leading Hibiclens range fall under Pharmaceutical industry regulations. We have a need to bring on board a senior person, responsible for developing our competencies and systems in the pharmacovigilance area.
Pharmacovigilance falls between and liaises closely with: Quality Assurance; Regulatory Affairs; and R&D. You will ensure our pharma regulated products adhere to local and international regulations.
You will be protecting our patients, our clients, and ensuring our company is compliant.
This is a very autonomous, visible and important role for Mölnlycke. You will be the first person we have hired into this newly created position and you will be responsible for building out our systems and procedures and aligning pharmacovigilance within our Quality Management systems.
What we want you to do:
Have ownership of the set-up and maintenance of an efficient and compliant Pharmacovigilance system in compliance with regulations and company policies and procedures.
Be the primary point of contact for pharmacovigilance system related questions, dealing with queries made concerning general pharmacovigilance issues.
Liaise closely with our external Pharmacovigilance service provider
Interact with the Mölnlycke EU Qualified Person Pharmacovigilance (QPPV) to maintain an effective Pharmacovigilance system
Be a point of contact for the relevant Regulatory bodies globally
Support all Quality Audits and External Inspections globally
Take Corrective and Preventative Actions to ensure that quality and regulatory compliance is attained and ensured for the future
Support functional management to ensure systems are updated and compliant
Train Mölnlycke staff on Pharmacovigilance
Monitor the global regulatory environment and react accordingly to ensure ongoing compliance

Who we would like you to be:
Degree in Pharmacy or Healthcare related subject. Further Post-Graduate eductation would be an advantage
5+ years' experience in Drug Safety roles within the pharmaceutical industry.
Fluency in English and Swedish
Strong knowledge of pharmaceutical regulations and ICH guidelines
Excellent communication and liaison skills
Expertise in Pharmacovigilance
Flexible to travel when necessary - travel is not a huge element of the role, however from time to time you may be required to travel internationally to oversee regulatory audits
Curious, passionate, articulate and with a real passion for ensuring patient safety.

This is a key role for Mölnlycke, and it is the first internal hire we have made in this area (previously we have relied on third parties), so it is important that the person we bring on board is an expert, and able to impart knowledge.
If you want autonomy and ownership of Pharmacovigilance in a global firm, if you'd enjoy learning about our sector as well teaching us about yours, and above all if you want to be a massively positive influence on our company, then we'd love to hear from you.
www.molnlycke.com/careers
About Mölnlycke
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.
We specialise 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.