Regulatory, Medical and PV Data Management Associate

Swixx Biopharma is staffed by a group of experts and medical professionals who are dedicated to bring modern medicines to the people! We are a service-oriented, high quality and ethically driven company.

With over 1,600 employees and sales which exceeded 900M Euros in 2023, Swixx has swiftly evolved into one of the largest and fastest-growing dedicated agents for biopharma in the Central, Eastern and Southeastern regions of Europe. 

The company opened in MENA in late 2023. In May 2024, Swixx expanded to Latin America with a strategic acquisition and combination with Laboratorios Biopas SA. Through Biopas’ comprehensive Latam continental coverage, Swixx is now able to provide a compelling offering covering Central and Eastern Europe, CIS/Eurasia, MENA and Latin America.

Swixx Biopharma has been recognized as one of Europe’s Fastest-Growing Companies for 2024 by the Financial Times (FT).

We are looking for a new team member for the position of Regulatory, Medical and PV Data Management Associate​ (could be based in any country in Central Eastern Europe Region).

YOUR ROLE

As a Regulatory, Medical and PV Data Management Data Associate, you will:

As a Regulatory, Medical and PV Data Management Data Associate, you will play a crucial role in supporting data management processes across regulatory, pharmacovigilance, and medical functions. You will be responsible for maintaining accurate data tracking, ensuring compliance with legislation and partner agreements, and supporting the implementation of regulatory information systems. Your role will involve close collaboration with internal teams and partners to facilitate timely data communication, database management, and process improvements.

Key tasks:

• Work on assigned projects tasks in close cooperation with corporate and local regulatory, pharmacovigilance and medical functions and/or project management for all Swixx Biopharma and its partners’ products.
• Support internal tracking of information required by legislation, partner contracts or internal procedures, e.g. tracking of medical information (MI) requests, regulatory registrations of products, medical devices and food supplements, promotional and non-promotional materials.
• Reviewing trackers/ databases/ document repositories for consistency and accuracy. Reporting findings to the Manager and work with concerned parties to establish corrective and preventive actions.
• Support timely communication to partners of relevant data, including data/documents entry/up-load into the relevant regulatory databases.
• Collect relevant information/data for defined KPIs and communicate to the relevant parties in a timely manner.
• Act as “superuser” for certain regulatory databases and document repositories for concerned Swixx countries.
• Support of relevant IT software and tools, including implementation of a new regulatory information management system (RIMS)

YOUR PROFILE

Education

• University Degree in Pharmacy, Life sciences or related field

Previous Experience

• At least 3 years of work experience in the pharmaceutical industry in a similar position
• Experience in GxP functions like Regulatory Affairs, Quality assurance, Medical Information, PV

Language & Technical skills

• Fluent in English (verbal and written)
• Knowledge of MS Office, Adobe Acrobat, advanced MS Excel

Knowledge and expertise

• Understanding processes within GxP environment, e.g. Regulatory, Medical Information, QA processes, PV
• Experience with GxP IT databases (RIM, eQMS, etc)

Skills and abilities

• Communication, and teamwork skills.
• Effective collaborative abilities in a fast-paced setting.
• Ability to deliver results that meet high-quality requirements with tight deadlines.

WHAT YOU GET IN RETURN

• Opportunity to contribute & learn in customer-oriented & dynamic environment
• Be part of team driven by a cause
• Gain experience in multinational fast-growing company
• Collaborate with the best colleagues you could wish for

Sounds appealing? Please get in touch with us by submitting your application to address: [email protected]

Only short-listed candidates will be contacted. All applications will be treated in strict confidentiality.