Responsible Person for Pharmacovigilance

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7qv48v

We are growing, grow with us

Are you looking for a dynamic company with daily new challenges and opportunities?

Then, ClinOpsHub is your career opportunity. ClinOpsHub is one of the leading CRO in Southern Italy specialized in all aspects of drugs and medical devices approval and of the market development, in training projects and quality support.

Now we are ready to build a pre-marketing Pharmacovigilance Department

Your Profile

Education And Experience
- Bachelor’s Degree in Life Science
- Fluency in English
- A minimum of 2 years pharmacovigilance work experience, ideally within a service provider, or proven equivalent experience in global pharmacovigilance systems (all areas, not limited to case processing)
- Previous experience in the use and management of PV Safety Database and of Safety Regulatory Reports Management Database

Requirements:
- Must be living within the EU/EEA
- Knowledge of relevant italian and european legislative and non-legislative guidelines of pharmacovigilance
- Knowledge of MedDRA Medical Dictionary
- Familiarity with SUSAR submission to EV




- Familiarity with industry principles of pharmacovigilance
- Ability to organize operations and take over project management
- Ability to analyse and solve problems and to develop pragmatic solutions within regulatory framework
- Ability to balance client concerns and company interests
- Autonomous, concentrated and high-quality work
- Excellent oral and written communication skills
- Strong proactivity and attitude to create something new.

Your Job
- Building a pre-marketing Pharmacovigilance Department
- PV Quality system set up, management and maintenance of SOPs
- Carrying out, as contractually agreed, duties as laid down in Reg. EU 536/2014 and Guideline on Good Pharmacovigilance Practices (GVP)
- Experience in pharmacovigilance related questions within the department as well as for customers, national and international regulatory authorities
- Evaluation of the agevolazioni-risk profile of dru

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7qv48v