Safety Project Leader

Excelya>Full-time>Safety Project Leader

Description de l'emploi

Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.

We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.

For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.

To learn more about us, visit www.excelya.com

 

What we offer:

  • Quick development and career growth
  • Competitive remuneration
  • Laptop
  • Medical private insurance

 

The Position:

A Safety Project Leader is the project manager of the Pharmacovigilance (PV) & Safety team, responsible for the implementation/provision of the activities/services described within a project/service agreement. Safety Project Leaders are assuming full ownership of their assigned projects, including budget, contract maintenance (renewals, extensions, scope etc.), project quality and efficiency as well as audit readiness.

 

The Safety Project Leader assists/participates also to other projects of PV & Safety, where as a team member provides support/expertise to handling of product safety issues (e.g. pharmacovigilance, device or cosmeto-vigilance).

 

As FR responsible person for pharmacovigilance, ensures Marketing Authorisation Holders (MAH) comply with local pharmacovigilance requirements and is the contact person for the local Health Authority and the MAH’s EU-QPPV.

 

Main Duties

General Oversight:

  1. Ensures effective functioning of vigilance projects in compliance with Excelya procedures, client agreement, contract, local and global regulatory guidelines.
  2. Responsible for quality management, workload management, compliance management and document management across projects.
  3. Manages projects, allocates project team resources and provides support to the project team when needed.
  4. Monitors compliance/Key Performance Indicators (KPIs), keeps compliance/quality control metrics, KPIs metrics.
  5. Reviews expense reports, invoices and budgets for his/her projects.

 

Product Vigilance Activities:

  1. Perform as National Qualified Person responsible for Pharmacovigilance
  2. Perform/prepares/contributes to vigilance activities (e.g. vigilance trainings, risk management activities, vigilance related documents like aggregate safety reports, PV System Master File, Safety Management Plan)
  3. Participates in audits/inspections.
  4. Generates/reviews SOPs and Working Instructions.

 

Team Management and planning:

  1. May act as supervisor of assigned staff.
  2. Is involved in objective setting and annual appraisals of staff.
  3. Is involved in proposals and costings for pharmacovigilance business.

 

Client Relationship Management:

  1. Continuously works with internal and external clients to ensure satisfaction and that expectations meet Excelya standards
  2. Functions as the main contact person with clients and Health Authorities.

Minimum Requirements:

  1. Physician or pharmacist
  2. At least 5 years’ experience in pharmacovigilance, including experience in Local Literature Search, case report handling and performing as Local Qualified/Responsible/Contact Point for PV for post-marketing PV in France (or other European country
  3. Experience in project management with multinational company’s project(s) for at least 2 years
  4. Fluency in English and French
  5. Additional competency in one extra European language will be considered as an asset

 

Key Skills and Attributes:

  • Very good knowledge of MS Outlook, Word, Excel, Power Point
  • Excellent organization, communication, and negotiation skills
  • Proactivity, attention to detail and ability to multi-task
  • Ability to work with little or no supervision, self-motivated and able to work both independently and within teams
  • Goal/result oriented and problem-solving personality
  • Good time management skills and able to quickly adapt
  • Ability to perform as trainer and good presentation skills
  • Team and project management skills

Résumé

Contact

Candidater à cette offre

Opportunités d'emploi similaires