Pharmacovigilance associate

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Recordati
Paris
EUR 45 000 - 75 000
Faites partie des premiers candidats.
Il y a 4 jours
Description du poste

With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and turnover of over Euro 2bn.

We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries.

At Recordati, our mantra is simple. We’ve always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest – we want to give people the opportunity to be the best version of themselves.

This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases.

Recordati. Unlocking the full potential of life.

Job Purpose

Corporate Pharmacovigilance Associate in the safety profile evaluation group / charge de pharmacovigilance surveillance du profil de securité. Be the subject matter expert for safety for the assigned product in an international environment and be the SME for one process such as PBRER and/or RMP (to be defined).

Key Responsibilities
  • The pharmacovigilance associate is responsible for the assigned products with the support of a vendor.
  • Medical assessment at case level.
  • Literature review.
  • Signal detection activities (detection, assessment, actions taken) / monitoring the implementation of CCDS change in the local product information.
  • Safety analysis authoring.
  • Answer health authority questions during registration renewal.
  • PBRER strategy coordinate the authoring.
  • RMP with associated risk minimization activities.
  • Ensure process update with corresponding procedure for the assigned process.
  • Participate in inspections and audits.
Required Education

Pharm D, Physician, Scientific profile. Master in pharmacovigilance or strong PV experience in the safety assessment profile. 3-4 years in a similar position.

Required Skills And Experience

Organized, rigorous, accountable, committed, proactive, synthetic mindset.

Technical Competencies

Critical thinking, case analysis synthesis and case assessment, medical writing skills, project management, safety profile regulations and guidance knowledge.

Required Behaviours And Competencies

Accountability, focus on the target, team spirit, creativity and proactivity, flexibility.

Required Languages

Fluent in English.

Travel required in %

Very few.

At Recordati we believe in people! Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential.

We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.

If you are looking to join a company where you can try new things, speak openly, and be bold, we invite you to apply today.

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