Job ID : 969982 Date Updated : January 23rd, 2020
Deadline January 29th, 2020
French pharmaceutical company

Pharmacovigilance Specialist

Hiring Company Nihon Servier Co., Ltd
Location Tokyo - 23 Wards, Bunkyo-ku
Job Type Permanent Full-time
Salary Negotiable, based on experience

Job Description

The Servier Group is a French pharmaceutical manufacturer that imports, develops, sells and promotes pharmaceuticals, focusing on cardiovascular diseases, diabetes and metabolic diseases, central nervous system and neurological diseases, and oncology. Japan office was established in 1981.

We acquired oncology business last year for expanding the product lineup in the future. Asia is becoming one of the important markets for us, Japan and China are positioned as strategic bases for our future growth.

Main duties and responsibilities:

  • Safety assessment of domestic and overseas case information, literature information, and quality-related safety information
  • Collection, evaluation, reporting, follow-up, and data management of safety information (adverse event) on marketed products and investigational products
  • Preparation of various periodic reports
  • Preparation and Implementation of Early Post-marketing Phase Vigilance
  • Drafting and implementation of safety assurance measures
  • Drafting and revision of the Risk Management Plan (J-RMP)
  • Preparation of re-examination
  • Negotiations with other departments, partner companies, HQ, CRO, and regulators
  • Oversight the partner company and CRO
  • Ensuring the compliance with laws and regulations in Japan, the United States, and Europe, and SOPs
  • Response to Inspection and audit of domestic and overseas internal and regulatory authorities

Opportunities for use your language ability:
E-mail, reporting to the manager of Pharmacovigilance department, Teleconferencing and face-to-face meetings with France Headquarters/APAC management and relevant team members. You will mainly use your English skills when communication with overseas teams.

Department info:
Pharmacovigilance group in the Japan. Comprises of three specialists working within this team, all of them have extensive experience in pharmaceutical industry.

Attractive points:
Career progression

You will be able to develop your career through experience of working on all aspects of safety activities, including safety reporting, risk management, from clinical trials through to post-marketing phase.

Working environment
Nihon Servier is facing a period of change with the plan to introduce attractive new specialty products for selected target markets. Accordingly, you have opportunity to try exhibiting your full capabilities under this challenging yet dynamic period together with your global colleagues. Our business size can provide quite a flexible working environment which cannot be found at large companies. Actually, there are a number of employees who have been working for the company for more than10 years. If you are looking for career development to become a globally viable business person, Nihon Servier has good working environment and this opportunity waits for you!

General Requirements

Minimum Experience Level Over 3 years
Career Level Mid Career
Minimum English Level Native
Minimum Japanese Level Fluent
Minimum Education Level Bachelor's Degree
Visa Status Permission to work in Japan required

Required Skills

Required of Experiences:

  • Minimum 3 years work experience in pharmacovigilance for drug in development or drug reexamination
  • Business level English skills (reading, writing and speaking)

Preffered:

  • Pharmacist License
  • Experienced in preparing risk management plans and various periodic reports
  • Experienced in Argus J implementation or update

Competencies:

  • Either experience of RMP (Risk Management Plan, safety assurance activities such as EPPV, Blue Letter and/or revision of pharmaceutical attachments, etc) or Argus (Safety Information system, including system implementation and/or system usage)
  • Knowledge of GPSP, GVP, GCP and related laws and regulations
  • Communication and project management skills
  • Leadership in difficult situations

In Additional:
Employment Type: Regular full-time
Probation Period: 6 months
Salary Payment: Monthly Payment
Incentive: Twice per year
Bonus: Around 10% of base salary
Total Annual Salary Range: around 5 Mil – around 9 Mil JPY (according to skill set and work experience)

Work location: Hongo MK Bldg, Hongo 1-28-34, Bunkyo-ku, Tokyo, Japan, 1130033
Nearest Stations: Marunouchi Line, Hongō-sanchōme Station

Working/Break Time: 9:15~17:15 (Break Time 1h、12:45~13:45)※flextime
Holidays: Sat, Sun, National Holidays, Summer Break and Others
Paid holidays: Depend on the timing when you join. (Second year: 20 days private holiday a year growing year by year)
Commutation Allowance: Fully paid
Benefits Program: Full (Health Insurance, Employee's Pension, Employment Insurance and Industrial Injury Insurance)

Job Location

  • Tokyo - 23 Wards, Bunkyo-ku
  • Marunouchi Line, Hongo Sanchome Station

Work conditions

Job Type Permanent Full-time
Salary Negotiable, based on experience
Work Hours 9:15~17:15 (Break Time 1h、12:45~13:45)※flextime
Holidays Sat, Sun, National Holidays, Summer Break and Others
Job Division Pharmacovigilance Department
Hiring Company Information

Nihon Servier Co., Ltd

Pharmacovigilance Specialist - 969982

Company Details

Company Type Small/Medium Company (300 employees or less) - International Company

Company Description

One of the biggest pharmaceutical company in the world
The Servier Group is an international and independent pharmaceutical company governed by a non-profit foundation, with headquarters in Suresnes, France. Since opening our first laboratory in 1954, we have been committed to therapeutic progress to serve patient needs with the help of healthcare professionals. 

Operating in 149 countries, we have 22,000 collaborators employed worldwide and a turnover of 4.176 billion euros in 2018. Entirely independent, we are able to reinvest 25% of our total revenue (excluding generics) into Research and Development, and all profits are used for further development.