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Corporate Pharmacovigilance Assistant M/F

CDI
Marseille
Salaire : Non spécifié
Télétravail fréquent
Expérience : > 2 ans
Éducation : > Bac +5 / Doctorat

Provepharm
Provepharm

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Le poste

Descriptif du poste

Main missions

Directly reporting to the Head of Global Pharmacovigilance, within the Global Medical Affairs, you will participate in the evaluation and monitoring of risks related to the use of the drug before and after marketing, the implementation of measures to reduce these risks, the promotion of the proper use of the drug by guaranteeing patient safety, notably on a portfolio of products marketed in the US. This position will also contribute to supporting Medical Information on this Portfolio.

Your main missions are:

• Within the framework of Global Pharmacovigilance and Global Medical Information regarding the portfolio of products marketed in the US:

  • To participate in the writing and the review processes of PV documents for development and post-marketing activities: Prepare and review PADERs, DSURs,
  • To participate in the evaluation of the risk/benefit ratios of the portfolio’s products (Assessment and Reports),
  • To follow-up and monitor the activities of the subcontracted PV Provider,
  • To coordinate with Global Regulatory Affairs for Pharmacovigilance document,
  • To coordinate with the US Branch of Provepharm for Pharmacovigilance and Medical Information activities.

• To support the Head of Global Pharmacovigilance and Global Medical Information on activities aiming at:

  • Guaranteeing a robust and reliable Global Pharmacovigilance and Medical Information system which can meet international requirements,
  • Updating the PSMF and the Global SMP,
  • Following up and monitoring the activities of the other subcontracted PV Providers,
  • Monitoring the existing PV processes and the implementation of new PV processes as part of the QA continuous improvement process,
  • Participating in regulatory monitoring and apply the regulations in terms of Pharmacovigilance,
  • Managing and processing of pharmacovigilance information from the reporter to the authorities (collection, management, assessment, reporting),
  • Participating to the signal detection process,
  • Participating to the benefit/risk assessment for the marketed products,
  • Participating to the Pharmacovigilance training of employees and subcontractors.

Profil recherché

You have a Doctorate in Medicine or Pharmacy or a Master’s Degree in Pharmacovigilance or the equivalent, and you have a successful 2 to 5 years’ experience in this type of position, if possible, in an international context (notably Europe and USA).

Your English level is at least B2.

Professional, rigorous, committed, you put the patient first and show a real empathy with his expectations and challenges. Passionate about your job, with a strong sense of suggestion, you are exemplary, ethical and have integrity in your daily approach.
Organized, endowed with a spirit of analysis and synthesis, you are autonomous and enjoy sharing with the teams in place in a collaborative and very positive approach.
Your very good interpersonal skills, your composure and your ability to be both reactive and calm, allow you to rise to the heights necessary for the position while remaining very sensitive to details and the reality of the field.
You know how to be innovative in the respect of procedures and bring a strong credibility to your function by your management of priorities and your adherence to the company’s values.


Déroulement des entretiens

1- You send us your application;
2- We study it with the greatest interest and send you a feedback within 15 days;
3- HR meets with you during a 30-minute telephone conversation;
4- You meet with the manager and then with HR;
5- A complementary interview with the Top Management and the HR Direction is usually done to select the best candidates;
6- We carry out a reference check;
7- We make you a proposal and you join our teams as soon as possible!

Do you think you meet the profile we are looking for, and do you consider yourself to be a committed, honest and daring person?
Our history, our ambitions and our culture seem to correspond to what you are looking for in a company?
Then don’t hesitate and send us your application 😉

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