Senior Associate Global Safety (M/F/D), Lisboa

Estamos a reforçar a nossa equipa na área de Safety e procuramos profissionais dedicados, com forte sentido de responsabilidade e motivação para trabalhar como Safety Specialist.

Funções e Responsabilidades:

Core Safety Activities

• Timely and accurate capture, routing, translation and follow up of adverse events reported in Portugal for inclusion in the Global Safety database (ArisG).

• Assist with the timely submission of all reportable adverse event reports.

• Maintain compliance with local legislation and Amgen policies and procedures.

• Support the local business by participating in local cross-functional team meetings and providing safety expertise and guidance.

• Identify, prioritize and appropriately escalate safety issues.

• Maintain current knowledge of Portuguese pharmacovigilance regulations.

• Keep local safety procedures and reporting requirements up to date.

• Ensure local safety activities are appropriately documented, filed and archived in accordance with Global Patient Safety requirements.

• Support adverse event reporting training for customer facing staff, contractors, distributors and other relevant third parties.

• Support local audits, inspections and other interactions with Health Authorities.

• Assist with Pharmacovigilance Agreements and other relevant contracts, as applicable.

• Support the implementation of urgent safety communications (DHPCs, DILs) and risk minimization measures according to local requirements.

• Assist with local medical literature screening.

• Participate in CAPAs and other quality improvement activities.

• Contribute to maintaining inspection readiness of the local Safety function.

Collaborative Activities

• Participate in global, regional and local Safety meetings.

• Contribute to Safety and cross functional initiatives to share best practices.

Therapeutic Area Safety Support

• Escalate product safety issues to the Iberia Safety Senior Manager.

• Develop expertise in the Amgen product portfolio.

• Maintain awareness of current prescribing information and Risk Management Plans.

Using expertise and information from the Product Safety Teams, the individual may also:

• Represent Safety in local Medical meetings to discuss product safety issues.

• Contribute to responses to internal and external safety questions in collaboration with Medical and Regulatory Affairs.

Knowledge and Skills

• Practical understanding of local pharmacovigilance legislation.

• Computer literacy, including experience with safety databases (ArisG experience preferred but not essential).

• Knowledge of local data privacy requirements.

• Understanding of medical and pharmacovigilance terminology.

• Ability to identify, prioritize and escalate safety issues.

• Strong problem solving skills.

• Ability to independently perform core operational safety activities following appropriate training.

Requisitos:

Education and Experience

• Degree in Life Sciences.

• At least 2 years of experience in a pharmacovigilance role within the pharmaceutical or biotechnology industry.

• Fluent written and spoken English.

• Ability to understand Spanish sufficiently to contribute to the Iberia team (preferred but not essential).

Oferecemos:

Nos termos da Directiva (UE) 2023/970, a remuneração base de entrada para esta função é de 33.000€ brutos anuais, definido consoante a experiência demonstrada;

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