DRUG SAFETY SPECIALIST (PATERNITY LEAVE)

Our client: Since our inception, we have strived to drive innovation to improve people's lives. We are an international pharmaceutical company with more than 90 years of experience and a targeted expansion course. With our pharmaceutical operations in Spain, Portugal, Germany, France and the United Kingdom, we supply medicines to more than 7 million patients worldwide. With our state-of-the-art industrial sites in Spain, Mexico and China, we are able to cover the contract manufacturing (CMO) business. The pharmaceutical and contract manufacturing platforms allow us to continue to address gaps in medical care needs with passionate dedication. Our product portfolio includes drugs for the treatment of serious diseases in the therapeutic areas of oncology and pain, central nervous system, ophthalmology, neurology and dermatology. At our client are proud of our values: We focus on people, we live transparency and take responsibility. They are reflected in everything we do, and have been since our beginnings, because as a healthcare company we have a great responsibility towards people and the environment. Role Summary: Protecting and improving patient care and safety in relation to the use of medicines and all medical and paramedical interventions. Promoting the safe, rational and effective use of medicines. Promoting education, understanding and clinical training in Pharmacovigilance (PV). Evaluating the benefit, harm, efficacy and risk of medications, carrying out continuous benefit-risk evaluations of medicines. Ensuring compliance with PV obligations under current legislation on the safety of medicines and PV. Maintaining a robust PV system for the performance of the PV activities for all the medicinal products at our client. FUNCTIONS Management of suspected adverse drug reactions (ADRs) and serious adverse events (SAEs). Preparation of aggregate reports: Periodic Safety Update Reports (PSURs), safety documents for renewals, Risk Management Plans (RMPs) and expert reports. Management and assessment of signals for company marketed products. Continuous safety profile review along life-cycle of the company products. Updating and maintaining the Pharmacovigilance System Master File (PSMF). Preparation, review and update of Standard Operating Procedures (SOPs) and Working Instructions (WIs) of the company’s PV system. Participation in PV audits and inspections. Ensuring readiness for PV audits and inspections. CAPA and deviations management. Preparing answers to requests from the competent authorities on drug safety. Contributing to the maintenance of an adequate archive. Promoting and complying with the applicable regulations (for example GVP, GCP, data privacy), operating regulations in general (SOP), as well as the procedures in the systems regarding the prevention of occupational risks and the environment, with the prior and relevant training in the field. All this while ensuring the maintenance of the confidentiality and security of the information. Keeping in place key performance indicators (KPIs) to assure that PV activities are conducted according to the legislation and SOPs. Review of the safety sections of the Product Information in collaboration with Regulatory and Medical Affairs. Monitoring, gathering, and analyzing the available regulatory information from competent authorities and Pharmacovigilance Commitee's (Regulatory Intelligence). Implementing, where necessary, the PV activities or risk minimization measures for company products. Surveillance of health products, cosmetics, and food supplements. Creation and review of the Company Core Safety Information (CCSI) defined as relevant for the company in collaboration with Medical Affairs. Collaboration in the review and update of Safety Data Exchange Agreements (SDEAs) and the relationships with the different partners/CROs. Review of the scientific literature on suspected ADRs of any active ingredient of which at our client group is the owner or according to the PV agreement. Required Studies: Bachelor in any Health Sciences Excellent verbal and written communication skills in English. High organizational and analytical skills. Fluent use of office tools. Able to work in an environment with changing priorities. Ability to work independently as well as in a matrix organization in teams. Professional experience: At least 3 to 6 years of experience in Drug safety and Pharmacovigilance in Pharmaceutical Industry, both Local and International Other specialized knowledge: Argus Safety Database or other safety databases Knowledge in GVPs Health Sciences background for the evaluation of the benefit/risk ratio of the medical products Languages: English Spanish Catalan