Pharmacovigilance associate

Recordati


Date: il y a 5 jours
Ville: Puteaux, Île-de-France
Type de contrat: Temps plein
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 a 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 assessement at case level
  • literature review
  • signal detection activities ( detection, assessement, action takens ) / monitoring the implementation of CCDS change in the local product information
  • Safety analysis authoring
  • Answer to 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 to inspection and audits

Required Education

Pharm D, Physician, Scientific profile

Master in pharmacovigilance or strong PV experience in the safety assessment profile

> 2 years experience required in similar position

Required Skills And Experience

organized, rigorus, accountable, committed,proactivity, synthetic mindset

Technical Competencies

critical thinking,

case analysis synthesis and case assessement

medical writing skills

project management

Safety profile regulations and guidance knowledge

Required Behaviours And Competencies

accountability

focus on the target

team spirit

creative and proactivity

flexible

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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