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Local Drug Safety Unit & PV Manager - Menarini Hellas

Menarini Hellas, an international pharmaceutical company is looking for a dynamic professional to staff the position of Local Drug Safety Unit & PV Manager.

The candidate will be the Local Qualified Person.

The Main Responsibilities Include

  • Applying and maintaining/managing the Pharmacovigilance system at local level in compliance with the corporate procedure, applicable requirements, including local ones and guidelines.
  • Management of Pharmacovigilance activities for corporate and local products.
  • Developing local procedures, SOPs in compliance with all applicable written procedures of Menarini group and with local ones.
  • Keeping under control the safety profiles and any emerging safety concerns in relation to the local medicinal products.
  • Maintaining system oversight and overview of the safety profiles of local products.
  • Acting as a single contact point for the Local Competent Authorities on a 24-hour basis.
  • Ensuring in cooperation with the Local Trainer that training programs are up to date, well documented and that associated records are kept.
  • Acting as a contact point with clients, consumers, healthcare professionals and Competent Authorities, regarding PV issues.
  • PV reporting to headquarters.
  • Monitoring national PV regulations and revise local action plans to meet the requirements, regarding PV issues.
  • Following up safety issues.
  • Keeping tracks and organises medical information responses.

Skills and Qualifications (desired)

  • University Degree in Pharmacy, Medicine, Biology, Chemistry.
  • Minimum 3 years of experience in PV department.
  • Fluency in English / Fully computer literate.
  • Strong knowledge of all regulation, legislation, policies and procedures related to PV issues.
  • High level of confidentiality and integrity.
  • Independent, confident, self-driven, pro-active, extrovert, dynamic with “can do attitude”.
  • Good analytical and time management skills.
  • Team player.

Remuneration

The company offers a competitive remuneration package and career prospects.


If you meet the above qualifications and believe that you can respond dynamically to the requirements of the position, please send us a curriculum vitae by entering the code position PV_2019 at Αυτή η διεύθυνση ηλεκτρονικού ταχυδρομείου προστατεύεται από τους αυτοματισμούς αποστολέων ανεπιθύμητων μηνυμάτων. Χρειάζεται να ενεργοποιήσετε τη JavaScript για να μπορέσετε να τη δείτε.

All applications will be treated as confidential.

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