Medicine Safety Expert

We are seeking a detail-oriented and organized professional to fill the role of Pharmacovigilance Specialist. This position will be responsible for supporting the maintenance of a globalized pharmacovigilance system, with a focus on preparing and writing aggregate reports.

The successful candidate will collaborate closely with pharmacovigilance teams across different business units to ensure high-quality safety documentation and regulatory compliance. This is an excellent opportunity for someone who wants to analyze risks of medical products from the perspective of their benefits to patients and society.

Responsibilities

Prepare, review, and notify aggregated safety reports (PSURs / DSURs) and Risk Management Plans (RMPs) to Health Authorities under supervision.

Collaborate on medical queries related to pharmacovigilance activities.

Contribute to the maintenance and execution of the Global Signal Detection process.

Ensure timely and accurate preparation of safety documents in compliance with regulatory requirements and company standards.

Work closely with cross-functional teams to collect relevant data and ensure consistency in safety documentation.

Requirements

University Degree in Health Sciences (Pharmacy, Medicine, Odontology). In case of Biology, Biotechnology, etc., it shall be necessary a Health Science orientation.

Languages : Fluent Spanish and English.

Experience : At least 4 years of experience in pharmacovigilance and drug safety.

Knowledge of signal detection and risk management in accordance with GVP. Deep knowledge of current European PV Legislation and ICH / Regulation. Knowledge and management of electronic PV databases such as Argus.

Flexible start time from Monday to Friday (full-time 40 hours).

Life and accident insurance.

Ticket Restaurant.

Co-payment in voluntary health insurance.

About Us

We value equality and fairness in all our processes. We do not discriminate against any person on the grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.

#J-18808-Ljbffr