Responsible Person For Pharmacovigilance Ne

Responsible Person For Pharmacovigilance
Ne
Liguria, Ne

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 benefit-risk profile of drugs based on current scientific knowledge - this includes the creation of safety update reports DSURs (Development Safety Update Reports), risk management plans and signal detection reports

- Preparation and review of Clinical Expert Statements regarding requests from competent authorities

- Set-up and maintenance of PV agreements of clients with their contractual partners

- Close cooperation with the Marketing Authorization Holder as well as related departments and functions

- Regular monitoring and evaluation of changes in pharmacovigilance regulations regarding the Pharmacovigilance System

- Training of the ClinOpsHub junior resources

Additional information:

- Full-time position

- In-office (Mesagne, BR, Italy) or remote based.

Contratto di lavoro: Tempo pieno, Tempo indeterminato

Stipendio: Fino a €40. 000. 000, 00 all'anno

Benefit:

- Alloggio

- Cellulare aziendale

- Computer aziendale

- Lavoro da casa

- Supporto allo sviluppo professionale

Orario:

- Turno diurno

Tipi di retribuzione supplementare:

- Premio di produzione

- Quattordicesima

- Tredicesima