Zambon Spa Bresso

Pharmacovigilance Standards & Training Specialist

For our Corporate Drug Safety Department, we are looking for a "Pharmacovigilance Standards & Training Specialist". 

 

JOB PURPOSE 

  • Maintain Zambon global PV Policies, Procedures and Work Instructions to support efficient PV processes and compliance with prevailing regulations;
  • Oversight of relevant worldwide regulations and upcoming changes with potential impact on Zambon PV system to ensure continued adherence to the highest standards;
  • Preparation and implementation of PV training programs worldwide, including the annual PV training for all personnel, specific training to PV personnel and service providers on Zambon Policies, SOPs, WIs, and the use of the safety database, in collaboration with relevant internal and external subject matter experts
  • Oversight of PV training compliance
  • Support case processing and/or aggregate reports preparation and/or signal detection, as needed. 

 

KEY RESPONSIBILITIES 

  1. Coordinate PV training worldwide in collaboration with other departments (e.g., QA, HR, Affiliates) and monitoring training compliance
  2. Conduct training sessions to safety personnel, affiliates, Sales Forces, service providers, as needed.
  3. Maintain accurate records of training materials
  4. Perform regular screening of PV legislation worldwide and assess the impact on Zambon PV processes
  5. Review and update, as needed, PV Policies, SOPs, work instructions, involving the relevant subject matter experts
  6. Provide support to case processing and/or aggregate reports preparation and/or signal detection, as needed.

 

ACADEMIC BACKGROUND

A Bachelor’s degree is required.

 

PROFESSIONAL EXPERIENCE 

A minimum of 3-5 years experience in pharmacovigilance.

Familiarity with operational, quality assurance, and drug safety procedures and regulations.

 

TECHNICAL SKILLS

  1. IT Tools - Preferred: familiarity with Oracle Argus
  2. English language
  3. Knowledge of PV legislation and guidelines
  4. Project Management
  5. Preferred: Knowledge of medical devices and/or food supplements legislation

 

COMPETENCIES

  1. Attention to timelines and quality standards
  2. Interpersonal skills
  3. Ability to mentor
  4. Ability to analyze information from multiple sources
  5. Teamworking
  6. Coordination skill
  7. Problem Solving
Caricamento...

Inoltra ora la candidatura

Ti invitiamo a compilare il form sottostante per inviare la tua candidatura.