Pharmacovigilance Specialist
hace 2 semanas
**This role is ideal if you're looking to start your career in pharmacovigilance, it's not required that you have experience in the field, but it will be a plus**:
- Fixed-term role, for 6 months
- Full-time position, Monday to Friday
- Work modality: Home-based
- May require working on ARG national holidays
Job Overview
Review, assess and process Safety data and information (adverse event reports), across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members.
**Essential Functions**
- To Prioritize and complete the assigned trainings on time.
- Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
- To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events (AE)/endpoint information
- determining initial/update status of incoming events
- database entry
- coding AE and Products, writing narratives, Literature related activities as per internal/ project timelines.
- Ensure to meet quality standards per project requirements.
- Ensure to meet productivity and delivery standards per project requirements.
- To ensure compliance to all project related processes and activities.
- Creating, maintaining and tracking cases as applicable to the project plan.
- Identify quality problems, if any, and bring them to the attention of a senior team member.
- To demonstrate problem solving capabilities.
- To mentor new teams' members, if assigned by the Manager.
- Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.
- 100% compliance towards all people practices and processes
- Perform other duties as assigned.
**Qualifications**
- Bachelor’s degree in Life Sciences required; students will be considered as well
- English advanced, mandatory
- Portuguese advanced, desirable
- 1-1.5 years of relevant work experience, ideally in health care or clinical research environment
- Working knowledge of applicable Safety Database, desirable
- Knowledge of applicable global, regional, local clinical research regulatory requirements. Beginner
- Strong organizational skills and time management skills.
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