Pharmacovigilance (Ae Intake) Specialist, German

Vor 2 Tagen

Wien, Österreich IQVIA Vollzeit

We are looking for the best talent, with German and English language expertise to be part of a global team that partnership with a major pharmaceutical company, working with patient safety on post-market products.

**Summary**:
Review, assess and process safety data and information, 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.

**Key responsibilities**:

- To Prioritize and complete the assigned trainings on time.
- Receiving, reviewing and interpretation of medical report.
- 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.
- Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.
- 100% compliance towards all people practices and processes.

**Minimum Required Education and Experience**
- Must be native/C2 level German and fluent in English language.
- Bachelor’s Degree in scientific or healthcare area.

**Skills and Abilities**
- Excellent attention to detail and accuracy.
- Good knowledge of medical terminology.
- Working knowledge of applicable Safety Database.
- Self-motivated and flexible.
- Ability to follow instructions/guidelines, utilize initiative and work independently.

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