Offer summary

Qualifications:

Fluency in Portuguese and English, Minimum of 2 years experience in Pharmacovigilance or related field, Strong knowledge of Pharmacovigilance practices and regulations, Experience with case processing activities and safety reporting systems.

Key responsabilities:

Review adverse event reports

Perform case processing activities and signal detection

Collaborate with teams for accurate reporting

Participate in process development and training

Job description

Luminary Group is currently seeking a highly motivated and detail-oriented Pharmacovigilance Associate who is fluent in Portuguese to join our team. This position offers the opportunity to work 100% remotely. As a Pharmacovigilance Associate, you will play a crucial role in monitoring and ensuring the safety and efficacy of our client's pharmaceutical products.

Responsibilities:

Review and evaluate adverse event reports and other safety-related information for our client's products.
Perform case processing activities, including data entry, coding, narrative writing, and quality checks.
Conduct signal detection activities and contribute to the preparation of signal evaluation reports.
Collaborate with cross-functional teams to ensure timely and accurate reporting of adverse events to regulatory authorities.
Participate in the development and implementation of Pharmacovigilance processes and procedures.
Assist in the training and mentoring of junior team members.
Maintain knowledge of current regulatory requirements and guidelines related to Pharmacovigilance.
Ensure compliance with company policies and standard operating procedures.
Contribute to the continuous improvement of Pharmacovigilance activities and systems.

Requirements

Fluency in Portuguese and English, both written and spoken.
Minimum of 2 years of experience in Pharmacovigilance or a related field.
Strong knowledge of Pharmacovigilance practices and regulations.
Experience with case processing activities, including data entry, coding, and narrative writing.
Proficiency in using Pharmacovigilance databases and safety reporting systems.
Ability to work independently and prioritize tasks effectively.
Excellent attention to detail and accuracy in data entry and documentation.
Strong analytical and problem-solving skills.
Good interpersonal and communication skills, with the ability to effectively collaborate with cross-functional teams.
Experience with MedDRA coding and EudraVigilance is desirable.
Flexible to work in different time zones, if required.