Administrativ Assistant / Office Specialist Qppv For Csl Behring In Bern

We make it GmbH is a national company operating in Switzerland, which, thanks to many years of successful experience, has a high level of expertise in the personnel services sector. Concentration of brokerage activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it
GmbH places the highest demands on quality, ethics and discretion.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, we develop and deliver innovative therapies that treat coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease, and neurological disorders. The company’s products are also used in cardiac surgery, burn treatment and to prevent hemolytic disease of the newborn.

Actively cooperate with GCSP internal functions and interface departments on a global basis to collect and collate relevant data for QPPV oversight.

Contribute to the compilation of the Pharmacovigilance System Master File (PSMF) in accordance with regulatory requirements, guidelines, and internal standards.

Support the regular updates of the PSMF to ensure it is up-to-date and ready for regulatory requests and inspections.

Contribute to or maintain other PV regulatory documents in line with international regulations, guidelines, and internal standards.

Support the development, establishment and maintenance of PV processes and systems by providing project support, as required. Assist in developing metrics to ensure QPPV oversight.

Assist in the preparation and conduct of PV inspections and audits, as required. As requested, organize, or support the back-office of regulatory PV inspections.

Contribute to the development and review of relevant QPPV and QPPV Office related procedural documents to meet local and international PV regulatory requirements Support the QPPV Office Lead in day-to-day activities, as required.

Experience:

Pharmaceutical industry experience of at least 1-2 years in Pharmacovigilance, Regulatory, Quality or relevant Clinical environment. Experience in regulatory inspections and audits.

• Knowledge of local and international regulatory requirements/regulations related to Pharmacovigilance and Good Clinical Practices
• Knowledge of pharmacovigilance systems and processes
• General understanding of quality systems and need for regulatory compliance
• Ability to work independently and as a team player, working in a cross-functional and global environment
• Self-motivated and able to prioritize and plan effectively
• Demonstrate initiate with a proactive approach to work
• Ability to evaluate, interpret and synthesize written information
• High level of computer literacy and proficiency in MS Office application
• Excellent written and verbal communication skills (English language)
• Attention to detail

Language Requirements:

• Fluent German and English.

Work hours

Remote work possible: 100 %

Are you interested?

Then Mr. Andre Amstad would be pleased to receive youre application documents (CV, Work reference letters and diplomas).

We look forward to hearing from you.