Product Safety Specialist
hace 2 semanas
About us
We are an international dermocosmetic company with a clear purpose: Inspire everyone we touch to enjoy healthy, happy, beautiful lives.
We are a purpose-driven company, and we want your day to day to have a positive impact on our communities and planet. We are proud to be B Corp certified. However, forming part of the solution also comes with great responsibility: to be a force for change towards a more sustainable world.
Do you want to join the Challenge?
What are we looking for?
What are we offering?
By joining Isdin, you can change the life of a lot of people worldwide.
In addition, we offer some interesting benefits, what makes us a top employer company:
Flexible entry hours and home office policy.
Private medical insurance.
Discount in our employee store.
Wellness benefits.
Christmas lot with several products.
What will your challenges be?
Conduct case management activities and review of scientific literature.
Signal management activities to determine whether there are new risks or whether risks have changed and whether those risks have an impact on the benefit-risk balance of the product and implementing corrective actions.
Prepare safety update reports, safety profiles, risk management plans, regulatory responses.
Prepare and review vigilance procedures, training and other documents or activities to support compliance in vigilance related activities.
Provide training on Product Safety to ISDIN employees and provide support to the ISDIN subsidiaries.
To manage deviations and Corrective and Preventive Actions (CAPAs).
Overview of safety profiles, safety concerns and commitments related to safety for products under clinical development or authorized.
Support the implementation and maintenance of the global and local vigilance system by conducting the applicable vigilance activities in accordance with legal requirements such as case management, contracts, aggregate reports, training, responses to health authorities/ partners, literature review and preparation of SOPs and other vigilance related documents, among others.
Support ISDIN subsidiaries and other Company areas in vigilance related activities: Regulatory Affairs, Clinical Development, Legal, Quality or Partners.
Are you the one we are waiting for?
Education: Bachelor of Medicine, Pharmacy, Biology or similar, or equivalent specific training in Pharmacovigilance (master's degree, postgraduate, etc.)
Experience: Minimum 3-5 years performing similar tasks.
Languages: English high level.
Others: Availability to travel.
Equal Employment Opportunities Employer
At ISDIN, we care above all about the talent you bring. That is why, throughout the recruitment process, we will respect the principle of equal opportunities, refrain from any kind of discriminatory attitude while always fostering our respect for people.
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