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Grow. Define. Innovate.
As one of the most respected partners to the life sciences industry, ProductLife Group (PLG) gives you the opportunity to advance your career and grow with like-minded regulatory, pharmacovigilance, and chemistry, manufacturing, and control professionals.
Join one of PLG’s teams of thought leaders, who are at forefront of the creation of innovative solutions and services that help the industry tackle complex challenges, from staying ahead of safety requirements to navigating complex regulatory developments across the globe. Our teams excel at their tasks, and you can take your first step toward professional excellence—and workplace satisfaction—by applying for a position at ProductLife Group. ProductLife is a service company that caters to pharmaceutical and cosmetic industry.
Our core competencies are rooted in pharmaceutical, regulatory and pharmacovigilance business.
Our group, which is headquartered in Paris (Suresnes) was established in 2004 and grows across European territories with affiliates in Switzerland, United Kingdom (Cambridge), Belgium (Roosdaal), Germany (Haan) and Italy (Milan).
We offer our customers a wide range of services including:
1. Operational Services
· as the management of product development activities
· taking activity records of products for loading on the market
· handling cases of pharmacovigilance
2. The expertise and advice to help our clients:
· in their strategic development choices (CMC expertise) or registration (regulatory expertise) and the establishment of new methods / tools
· adapt their information processes and systems to new challenges and demands imposed on them: new standard for managing product information (IDMP) need to integrate new territory / product portfolio / subsidiary
Depending on the type of activities, employees work in teams at our sites (Paris / Suresnes, Lyon / Vaux-en-Velin and Val de Rueil) and / or home office (mainly consulting) and are required to travel on customer sites.
All our staff are supervised and accompanied in their projects by our departmental heads, where we differ from conventional service companies is where employees are placed with customers and work directly under their control.
All of our teams reflect the diversity and complementarity of our expertise:
1. Team specializing in pharmaceutical development (CMC):
• Writing for registration dossiers (module 3, expert opinion ...)
• Project Manager role in monitoring development among manufacturers
• training and assistance to the development of methods like "Quality by Design" and HACCP
2. Team specializes in the development of cosmetics:
• By Platform: writing / regulatory review of documentation and Raw Materials Finished Goods, Preparation of product dossiers, CPNP notification, cosmétovogilance, toxicological assessment of products and substances, dual sourcing of raw materials.
• Among our clients: Micro and Analytical, Packaging development, development coordination in connection with the Commodities manufacturers and suppliers, preparation of the Product Information File
3. Pharmaceutical Quality (QA / QP):
• Support GMP (Good Manufacturing Practice) / GDP (Good Distribution Practices), implementation / maintenance of the Quality System, drafting procedures (SOPs) and other documentation quality audit of the Quality System
• role of QP (Qualified Person) for batch release
4. Regulatory Affairs (national and international platforms):
• Drafting / preparation of dossiers / variations and record data product (MA dossiers) in connection with national partners and agencies
• Strategic advice for certain types of application, due diligence preparation
• document management labeling (linguistic review, translations ...)
5. Regulatory Operations (RegOps):
• publishing of registration dossiers (including making preliminary document level if needed)
• management of regulatory information and database administration / support systems (RIMS XEVMPD / IDMP)
6. Help Desk and office administrative / data entry (Special Services):
• This service applies to the various areas listed here and carries out activities such as scanning, archiving, document formatting, processing / data entry in the context of a system migration, for example, or the management of administrative processes.
7. Pharmacovigilance (PV):
• management of the Pharmacovigilance System for products both in clinical development and marketed
• processing of cases of PV and reporting to authorities
• risk analysis, literature research, preparation for audits and inspections
8. Consulting: process optimization and information management, which apply to areas above and include the following activities:
• Support the definition / implementation of complex projects, scoping study and business case
• Formalizing requirements (specifications) and analysis / recommendations on processes, advice on the choice of information management systems, project management assistance
• Training and change management
9. Program Management Office (PMO):
• Project Team Leader responsible for managing complex projects, including implementation phases of our new strategic contracts.
The variety of our businesses and geographies various locations available to our employees who want them prospects. In this context, the knowledge of English is required.