Our client is an international pharmaceutical company and is looking for a “Junior Pharmacovigilance Officer (M/F)” to join their international operations office, based in Luxembourg.

Your main tasks :

•  Agreements / Archive :

Develop and maintain an effective pharmacovigilance archiving process and ensure that all data is kept in an inspection and audit ready state at all times.

Assist in the drafting and review of new and existing pharmacovigilance agreements and contracts with relevant stakeholders.

•  Data management / Submissions :

Ensure effective Safety Data Management processes and procedures, including source data entry and electronic data capture in the global safety database.

Actively assist Corporate Drug Safety in the data collection and assembly required to compile Periodic Safety Update Reports and Annual Safety Reports

Ensure workload is effectively prioritised to enable all submission and reporting deadlines to be met.

• Procedures :

Participate in the creation, updating and implementation of Standard Operating Procedures in-line with global procedures.

Implement and enforce Urgent Safety Restriction procedures when requested by Health Authorities or Corporate departments

• Inspections:

Provide support in the preparation of, and during, inspections and audits. Assist with the effective management of any follow-up measure or outcomes of such audits and inspections.

• Collaboration:

Develop and maintain an active interface with internal colleagues to ensure that they are kept informed of pertinent pharmacovigilance issues.

Develop a thorough understanding of the Quality Management System in order to facilitate any Pharmacovigilance interaction.

• Training :

Perform validated Pharmacovigilance training of company personnel in-line with corporate procedures and industry best practice.

• Personal topics :

Understanding of Pharmacovigilance within an international environment

Develop and maintain an in-depth knowledge of all pharmacovigilance issues and obligations relating to the company’s products

Maintain Pharmacovigilance knowledge and keep abreast of any regulatory, industry best practice and legislative developments.

 

Your profile :

Self-motivated

Excellent team working skills, capable of communicating and collaborating in an international environment

Effective planning and time management.

Excellent verbal and written communication skills.

Analytical and negotiation skills with meticulous attention to detail

Degree in Pharmacy or life sciences

Pharmacovigilance exposure and experience of at least 12 months

Fluency in English and in French, Italian or German

 

We offer :

An interesting career opportunity in a growing international company (position scope: Europe)

A good working atmosphere within the team

An attractive salary package commensurate with experience and advantageous taxation (Luxembourg contract)