XDES is specialist in recruitment van technisch personeel.
- Responsible for day-to-day adverse experience case management within the country(ies) covered by the country operation including case intake and follow-up activities in accordance with Global Safety procedures.
- Responsible for aggregate safety report submissions in the country(ies) in accordance with Global Safety procedures and health authority requirements.
- Responsible for the reconciliation of adverse events reports received from other operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners, as applicable.
- Responsible for the filing, storage and archiving of safety-related data in accordance with policies and local requirements.
- Participate in individual case safety report compliance activities and take the necessary corrective actions locally for the late reporting within the country(ies) covered by the country operation.
- Assist in preparation for audits/inspections for their country/territories and may participate in the audit and/or inspection.
- Identify and communicate potential safety issues to Country Lead.
- A health, life science, or medical science degree or equivalent by education or experience is required.
- A minimum of 1 year of pharmaceutical industry experience.
- Must have an awareness of Pharmacovigilance regulations within your assigned country(ies).
- Excellent written & spoken English.
- Ability to communicate effectively verbally and in writing.
- Proficient in local language(s).
- Proficient in Good Documentation Practices.
- Computer skills.
- Good word processing, presentation & spreadsheet application skills.
- Familiar with the use of a safety database.
- Ability to learn new computer interface systems.
- Personal Strong project management skills with the ability to prioritize assignments.
The Specialist is expected to have strong communication and time management skills, and have the ability to work independently with minimal supervision. Awareness of pharmacovigilance systems & requirements. Awareness of pharmacovigilance principles, concepts, practices & standards. Knowledge of the local country(ies) pharmacovigilance regulations & obligations. Awareness of Good Clinical Practice concepts.
Salary and Benefits
Contactpersoon voor deze functie is Peter Debrichy, bereikbaar op telefoonnummer 023 55 78 529 of via e-mail: email@example.com Kenmerk: 8607.
- Professionele ontwikkeling