RAPV Specialist

Posted 3 Days Ago
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Taipei City
Junior
Healthtech • Pharmaceutical • Manufacturing
The Role
The RAPV Specialist ensures compliance with regulatory requirements, manages adverse event reporting, and coordinates health safety training. Responsibilities include maintaining product license life cycles, supporting registration, and monitoring industry regulations for dermo-cosmetics. The role also involves managing safety reports and supporting export market regulatory compliance.
Summary Generated by Built In

Who we are ?

Pierre Fabre is the 2nd largest dermo-cosmetics laboratory in the world, the 2nd largest private French pharmaceutical group and the market leader in France for products sold over the counter in pharmacies. Its portfolio includes several medical franchises and international brands including Pierre Fabre Oncologie, Pierre Fabre Dermatologie, Eau Thermale Avène, Klorane, Ducray, René Furterer, A-Derma, Naturactive, Pierre Fabre Oral Care.

Your mission

Regulatory Affairs:

  • Maintain lifecycle for existing products, including license renew, PMF renew, post-marketing variations, etc.
  • Support product license registration and PMF registration.
  • Contribute to the discussion of registration plan with both local and global stakeholders.
  • Monitor Regulatory regulations and communicate relevant updates to related stakeholders.

Pharmacovigilance

  • Manage collection, processing, documentation, reporting and follow-up of all adverse event reports for medical care products.
  • Perform local literature search and report the identified adverse event.
  • Manage submission/distribution of safety reports/updates to Local Health Authorities.

Health Safety Environment (HSE)

  • Support in maintaining comprehensive HSE management systems, including identifying hazards and implement controls to mitigate risks.
  • Coordinate the HSE training programs to employees.
  • Assess the HSE compliance with the group's requirement that constitute the safety basics for our activities.

Dermo-cosmetic Support for Export Market

  • Fulfil Dermo-cosmetic distributors’ needs for PIF and scientific dossier inquiries.
  • Regularly monitor the latest regulatory change for cosmetic industry.
  • To monitor of cosmetic advertisement compliance for both own brands and competitors.
  • Parallel export/import tracking.
Who you are ?

We are convinced that diversity is a source of fulfillment, social balance and complementarity for our employees, which is why our offers are open to all, without restriction.

Top Skills

Health Safety Environment (Hse)
Pharmacovigilance
Regulatory Affairs
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The Company
Barcelona
8,877 Employees
On-site Workplace
Year Founded: 1962

What We Do

Pierre Fabre Group held by the Pierre Fabre Foundation, is a worldwide company with a unique positioning : the alliance of pharmaceutical and dermocosmetics expertise.

This makes Pierre Fabre Group :
A pharmaceutical group with a strong positioning : medical and natural
The second largest dermo-cosmetics laboratory in the world
The second largest private French pharmaceutical group
The market leader in France for products sold over the counter in pharmacies.

Our portfolio includes several medical franchises and international brands including ;
Pharmaceutical Care
Pierre Fabre Oncologie
Pierre Fabre Dermatologie
Naturactive
Eau Thermale Avène
Klorane
Ducray
René Furterer
A-Derma
Pierre Fabre Oral Care
Glytone (US)
Darrow (Brasil)

Established in the Occitanie region since its creation, we manufacture over 95% of our products in France. We keep innovating passionately with our teams in 2 innovation centers in Brasil and Japan as well as in 6 R&D centers in France.

Thanks to our 9,600 employees in 44 subsidiaries and our distribution activities in 120 countries, our group generated €2.7 billion in revenues in 2022, 69% of which is from international business.

Pierre Fabre Group has a unique company structure.
86% of the Pierre Fabre Group is held by the Pierre Fabre Foundation, a government-recognized public-interest foundation, while a smaller share is owned by its employees via an employee stock ownership plan.

In 2020, the independent organization ECOCERT Environment awarded Pierre Fabre's CSR policy at "excellence" level : - Excellence being the highest maturity level of the ECOCERT 26000 standard

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