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Local Safety Administrator / Quality Assurance Associate Baltics
Requisition ID: 1805633823W
At Janssen, part of Johnson & Johnson Family of Companies, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson. Please visit www.janssen.com for more information.
Local Safety Administrator and Quality Assurance Associate
The position is a permanent position and the employee will be working as Cross Sector Local Safety Administrator (0,5 FTE) and Quality Assurance Associate (0,5 FTE) and will be responsible for these activities in Baltics:
- Collection of adverse events and product quality complaints, filing and maintenance of all case file documentation;
- Coordination translation of local source documents as required;
- Conduct reconciliations with responsible parties and partners for adverse events and product quality complaints, monitor pharmacovigilance/business quality related legislation for Baltic countries,
- Support the implementation of compliance standards and collection of compliance metrics as required,
- Work with the Local Safety Officer, EMEA pharmacovigilance and Head of Pharmaceutical Activities and EMEA Business Quality teams;
- Schedule and coordinate pharmacovigilance/business quality training within the cross – sector J&J companies in Baltics (Pharma & Consumer).
- Educational background pharmacist, biomedicine or health care
- Min 1-2 years’ experience in Pharma industry on a similar position
- Experience from Pharmacovigilance and/or Quality Assurance is a strong merit,
- Communication skills for different groups in a highly regulated area – both internal and to external people
- Team player in a small team where the regulatory compliance for patient safety is the critical outcome
- Comfortable working with different global systems and good administrative skills to be inspection ready
- Strong work ethic, structure and results orientation.
- Proven self-starter with good initiative and enthusiasm
- Flexible and comfortable with ambiguity in a dynamic and changing environment
- Able to prioritize and multitask in a highly matrixed environment
- Good communication skills in English and Latvian language.
- An opportunity to be part of a global market leader
- A dynamic and inspiring working environment
- Many opportunities to work on challenging projects and assignments
- Possibilities for further personal as well as professional development
- Motivating financial remuneration
- Many employee benefits
JANSSEN-CILAG POLSKA SPOLKA Z (8426)