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Manager, Safety Operation/ Biopharma

 

A career at our company is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

 

JOB DESCRIPTION

 

TITLE

                 Manager, Safety Operations

 

 

REPORTING TO

Head of GPS Japan

Direct Reports

2 (could be changed due to org change)

PLACE OF WORK

Toyo

COUNTRY

JAPAN

FUNCTION/AREA

Global Patient Safety/Global Medical Affairs

 

Generic Job families

Job family according to global job catalogue

Pharmacovigilance - Drug Safety

Description of Job Family according to global job catalogue                                    

Establishes and maintains the local PV System in accordance with legal requirements, corporate standards and best practice within the pharmaceutical industry. Contributes to all local safety aspects of clinical development programs, observational studies and Patient Data Collection Systems sponsored by the company; performs active pharmacovigilance and product surveillance at local level in close collaboration with Global Patient Safety, to ensure up to date benefit-risk profiles of all products marketed by the affiliates.

 

 

SPECIFIC JOB DESCRIPTION

KEY ACCOUNTABILITIES
 

 

The manager in Safety Operations is accountable to ensure full compliance with all relevant global and local regulatory requirements, internal company standards and best practices in the pharmaceutical industry for pharmacovigilance (PV), especially case processing.

The accountabilities include:

  1. Management of the Safety Operation Group:

 

  • Leading and executing operational tasks in the affiliate/s relating to PV
  • Managing local PV vendors with assigned PV tasks
  • Implementation of processes and tools in a timely manner to ensure effective and efficient use of all resources
  • Management of work load and budget to meet defined objectives and targets
  • Creating a working environment that attracts and develops and retains good performers

 

  1. Local PV System
    • Establishing and maintaining the local PV System in accordance with global / local legislation and company standards
    • Accurate and complete documentation and maintenance of the local PV System in the local PV File (LPVF) based on the current LPVF template
    • Ensuring that all relevant process documents are current, complete, version controlled and retrievable

 

  1. Product safety surveillance
  • Handling of all local safety information, including collection, registration, translation from local language into English, and transmission to GPS as applicable in a timely manner
  • Seeking comprehensive initial and follow-up information on Individual Case Safety Reports (ICSRs) from all relevant spontaneous sources, and (where applicable) of cases from local interventional and non-interventional studies, Patient Data Collection Systems (PDCS) and quality complaints that are combined with adverse event information in a timely manner
  • Performing screening of relevant local medical/scientific literature in accordance with GPS procedures and local requirements
  • Performing screening of relevant local health authority web sites according to global standards as defined by relevant quality documents
  • Implementation and oversight of Risk Management Plans (RMPs) and additional Risk Minimization Measures as required in close collaboration with central GPS teams
  • Conducting signal management activities as described in GPS procedures and according to local requirements

 

  1. Reporting of safety information to local Health Authorities:
  • Reporting of relevant ICSRs to local Health Authorities as required
  • Reporting of relevant ICSRs to local Ethic Committees as required

 

  1. Involvement in local studies and Patient Data Collection Systems (PDCS)
  • Reviewing safety related contents of local study/PDCS documents (protocols, amendments, informed consent forms, contracts of 3rd parties involved in the studies) and providing safety input as needed
  • Ensuring appropriate safety procedures (including appropriate safety reporting to health authorities, regular reconciliation of safety data between applicable databases, safety training of all involved internal or external personnel, following up on specific issues until resolution)
  • Informing GPS on all new local studies as required and PDCSs as defined in the relevant quality documents
  • Performing required activities (such as review and input to safety section of study/project documents,  certification of programs, AE reconciliation, providing updates) for local studies /PDCS  as required and provision to GPS Regions
     

 

  1.  Local safety regulations and regulatory status
  • Continuous monitoring of local PV legislation in the country(ies) / territories of responsibility

                                         

  1.  Management of PV compliance at local level
    • Ensuring local compliance in accordance with local legislation and company standards/procedures
    • Providing regular compliance information to GPS in a timely manner
    • Ensuring appropriate root cause analysis for any identified deficiency in the local PV system (including audits/inspections)
    • Pro-actively identifying compliance issues and compliance gaps, following up and closure of observations in close cooperation with GPS and R&D QA
    •  

 

SCOPE OF PEOPLE RESPONSIBILITY

Management of people

  • Line and performance management of Sr. Patient Safety Associates and Patient Safety Associates
  • Identification and development of talent

 

CANDIDATE’S PROFILE

 

EDUCATION

        • Medical doctor, pharmacist, bio scientist, or similar qualification to be decided on individual basis
        • Excellent in written and spoken English and local language

WORK EXPERIENCE

        • PV experience: 

Must Experience in safety department (more than approx. 5 years) in an affiliate of middle or large-sized pharmaceutical companies.

        • People management

Preferable: Experience in people management as a line manager.  Experience in leading teams without official direct reports could be fine, if she/he has very interested in people management

        • Knowledge of regional and local PV requirements
        • Good understanding of drug development and life-cycle management

 

JOB-SPECIFIC COMPETENCIES & SKILLS             

        • Strong intercultural skills (developed from practical experience of international working)
        • Skills in people management, including driving performance and developing individuals
        • Strong team-working skills – working across cultural and functional boundaries, and leading ‘virtual teams’
        • Excellent problem-solving and decision-making ability
        • Excellent organizational skills, ability to prioritize work and adapt rapidly to changing priorities
        • Ability to manage multiple situations/issues under time pressure
        • Effective presentation and training skills

Recruiting contact: Fang LIU

 

What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

 

Curious? Apply and find more information at https://jobs.vibrantm.com

 

Job Requisition ID:  212964
Location:  Tokyo
Career Level:  E - Professional (10+ years)
Working time model:  full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


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