Monitoring and management of local reports of adverse reactions (ADRs/AEs) received from patients, healthcare professionals or other sources.

Ensuring 24/7 availability to manage safety emergencies (as required).

Collaborating with local regulatory authorities and participating in inspections/audits.

Carrying out periodic reconciliations with distribution partners and/or authorities.

Participate in the drafting and review of risk management plans (RMPs), periodic safety update reports (PSURs/PBRERs) and other relevant documents.

Monitoring the internet and local media sources for safety signals.

Ensuring training of company employees on PV obligations.

Contribution to maintaining the PV quality management system (SOPs, CAPA, deviations, etc.).

Proper archiving of pharmacovigilance documentation.

Attending safety meetings and maintaining good communication with global or regional PV teams.

Ensuring the prompt reporting of any new relevant information regarding the safety of products on the market.

Higher education in medicine or pharmacy;

Knowledge of current Pharmacovigilance legislation (GVP, EMA regulations, local requirements).

Fluent knowledge of Romanian, Russian, English;

Advanced computer user (Microsoft Word/Excel/Power Point);

Ability to work (intensely) independently and in a team (people skills, including the ability to communicate with people to achieve expected results);

Ability to work under pressure of deadlines;

Minimum 1 year of experience in a similar position is an advantage.

You have the opportunity to develop professionally and personally within the company;

We organize periodic trips for study and teambuilding purposes;

Individual coaching sessions;

Workshops and workshops for personal development;

Day off on your birthday;

You have the opportunity to advance within the company;

You will have a competitive salary + annual bonuses;

We offer lunch card with meal vouchers;

We organize annual corporate events;

Flexibility in organizing the work schedule, with the possibility of adjusting the start and end time of the work day;

We offer discounts on products sold by the organization (medicines, dermatocosmetics and optics);

The working conditions are very good (the offices are ergonomically designed;

Internal communication is transparent;

The management staff is always open to provide support and answer employees' questions;

The working atmosphere is warm and friendly;