Specialist Local Pharmacovigilance- German Speaker

Vor 6 Tagen

Berlin, Deutschland Cencora Vollzeit

**What you will be doing**:
Cencora Pharmalex is one of the leading service providers for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance. The success of our company resides in the expert knowledge and high motivation of our employees. Working for Pharmalex means being creative and adaptive. Our culture of continuous learning and commitment to diversity and inclusion creates an environment that allows you to build your skills and career.

**Responsibilities**:
**Operational Safety Management**
- Screening of local scientific literature (safety relevant publications), including creation of search algorithms for local literature screening
- Processing of Individual Case Safety Reports (ICSR) of adverse drug reactions deriving from clinical trials, spontaneous reporting systems and from the literature; reporting of ICSRs to the competent authorities
- Handling of Customer enquiries or complaints
- Assistance in the creation of periodic reports PSURs (Periodic Safety Update Reports), DSURs (Development Safety Update Reports), risk management plans and signal detection reports
- Translation German/English in the context of case processing, including quality checks of translations.

**First Level Medical Information**
- Receipt and management of Level 1 Medical Information enquiries, including triage for relevant area (pharmacovigilance and/or medical information and/or/product quality complaint) and data entry including translation German/English.
- Availability for phone calls during the project-specific business hours
- Escalating 2nd Level MI enquiries and other type of information

**Quality systems**
- Tests computerized systems according to validation procedures
- Perform quality control tasks such as project-specific quality checks

**Program Management Support**
- Support the Program Manager with all necessary information related to the specific project/program, as needed.
- Project management.

**What your background should look like**:
**Experience**:

- Professional education or University degree in Life Science preferred but not essential
- Basic understanding/knowledge in the field of pharmacovigilance and medical information is preferable but not essential

**Skills**:

- Ability to prioritize and manage own time and tasks.
- Ability to manage internal and external (client) relationships on operational / day-to-day working level as well as client's team lead level.
- Good communication skills (written and verbally); capability to point out issues and provide potential options for solution in the area of expertise.
- English business fluent in addition to fluency in German

**Schedule**:
Full time

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