gerente de farmacovigilancia en ciudad de mexico

ubicación
ciudad de mexico, cdmx
tipo de trabajo
indefinido
postúlate

detalles del empleo

publicado
ubicación
ciudad de mexico, cdmx
empleos por especialidad
Contabilidad y Auditoría
tipo de trabajo
indefinido
jornada laboral
Tiempo Completo
educación
Ninguno
referencia de la vacante
11675
consultor
randstad mexico staffing

descripción del empleo

-Individual is accountable for ensuring that pharmacovigilance systems are in place within the local organization in order to safeguard public health and maintain compliance with applicable regulatory requirements.

-To serve as the local safety officer for the Mexico Safety Organization.

responsabilidades

-Implement and maintain a pharmacovigilance system for the UCB products authorized in their
Territory and ensure compliance with applicable regulatory requirements;
-Maintain thorough knowledge of the national current pharmacovigilance regulatory requirements;
-Ensure communication of national pharmacovigilance requirements to global Patient Safety
-Ensure that all information relevant to the benefit/risk balance of the UCB products is reported to Patient Safety (including the EEA QPPV for products licensed in the EEA) for further review and to the competent authorities according to the local pharmacovigilance legislation;
-Work in close collaboration with global Patient Safety teams in order to ensure that local obligations are managed and compliance to local authorities is maintained;
-Maintain a functional connection with the EU QPPV, eg participating in regular LSOs meetings
organized by global Patient Safety
-Interface with key affiliate stakeholders and departments in the local UCB office to ensure that
pharmacovigilance requirements are implemented;
-Establish and maintain local Safety Data Exchange Agreements (SDEA), ensuring updates are
provided to Patient Safety (Safety Agreements team). Ensure oversight of global SDEA which apply in the territories under LSO responsibility

experiencia

- At least 5 years in Pharmacovigilance, - Scientific background in CNS and/or immunology helpful.

habilidades

- Ability to understand various key stakeholders and customers to respond appropriately
- Proficiency in use of PC applications.
- Ability to manage and meet deadlines.
- Ability to work effectively in a team environment.
- Ability to plan, organize, prioritize, and execute multiple tasks within assigned objectives.
- Excellent verbal and written communication
- Demonstrated ability to understand, analyze, and summarize scientific and medical information.
- Professional demeanour, team orientated, self-motivated, and ability to influence customers both externally and internally

certificaciones

- Bachelor's Degree: HCP based education (such as physician, pharmacist, nurse) or any relevant graduation/experience in medical-scientific area (such as PhD/master in biological sciences or related degree
- English (100%) must