Safety Officer

hace 2 semanas

Buenos Aires, Argentina Pfizer A tiempo completo

Organizational Relationship(s) including to whom the position reports (JD Job Title):

- Reports to Country Safety Lead or Safety Team Lead or Safety Officer with senior experience (depending on local organization and safety group size)
- Position Purpose
- Review, analysis, preparation and completion of safety-related reports within scope of the DSU to determine the safety profile of Pfizer products and to meet regulatory requirements. Provide specific pharmacovigilance knowledge and experience, as required by the business, and mentor colleagues accordingly. Manage resources in the safety team depending on local organization and safety group size.
- Primary Responsibilities
- Organize, manage and actively carry out as appropriate, local PV activities, such as adverse event monitoring, safety reporting, risk management, local safety monitoring activities as required by local agency, local contractual agreements, process documentation and training, inspection preparedness, and any other required country-specific safety activity
- When required by local regulations, and based on delegation from Country Safety Lead, act as a local QPPV/deputy local QPPV or local responsible/contact person for PV or deputy/back-up local responsible/contact person for PV
- Carry out all case management activities as appropriate
- Ensure regulatory compliance with timelines for individual expedited case report submissions and timely delivery of information for aggregate reports and other regulatory documents as requested
- Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios
- Ensure complete and timely forwarding of ICSR to Core
- Determine if appropriate case follow-up has been considered. Conduct follow-up activities when needed
- Analyze and monitor activities, define and implement corrective actions, where applicable
- Develop and maintain expertise of all assigned products, of applicable corporate policies and local regulations, guidelines, Standard Operating Procedures and writing practices, of data entry conventions, and of search functions in the safety database
- Provide oversight and team mentoring on case handling aspects, data extraction and analyses
- Manage, where applicable, safety resources in the local team
- Promote/participate, as appropriate, in local, internal and external safety activities- Technical Skill Requirements- Understanding and ability to use computer technology, management of relational database systems, including extraction of data
- Solid working knowledge of pharmacovigilance concepts
- Solid knowledge of national and international regulations
- Solid understanding of medical terminology
- Solid knowledge of global regulations and guidelines for drug development- Qualifications (i.e., preferred education, experience, attributes)- Health Care Professional or equivalent experience preferred
- Minimum 4 years’ experience in pharmacovigilance and/or data management, clinical care or clinical or scientific research required
- Experience and skill with medical writing an advantage
- Ability to independently solve routine problems related to case processing and surface issues constructively
- Ability to make decisions independently in both routine case processing and unique and/or complex situations, and to resolve issues appropriately to achieve a desired result or impact
- Ability to discern when additional input is required to effectively address unique and/or complex situations
- Strong skills in productivity, organizational and time management in order to meet strict regulatory compliance goals
- Ability to work independently to accomplish team goals with mínimal supervision
- Demonstrated ability to foster teamwork
- Fluency in spoken and written English
- "En Pfizer tenemos el objetivo de ser tan diversos como los pacientes y las comunidades a las que servimos, a través de una cultura vibrante y enriquecida por la mezcla de nacionalidades, identidades, edades, géneros, experiências, tradiciones y capacidades. Estamos comprometidoscon atraer talento basándonos en las habilidades y experiências imprescindibles para realizar el trabajo.
- Si te interesa sumarte a Pfizer, envíanos tu solicitud sin agregar foto, edad, estado civil o cualquier otra información que consideres innecesaria para la posición que estás aplicando.
- Traé tu auténtico ser al trabajo - Bring your authentic self to work - “

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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