Date Posted:
Salary:
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Job Description

Primary Accountabilities

  • Responsible for implementing and maintaining an effective local PV system for a single affiliate (or multiple affiliates/countries in case this has been agreed) that ensures ongoing compliance with global Roche and local legal / regulatory authority PV requirements.
  • Responsible for the oversight of all aspects of the local PV system. This includes consistency in execution, monitoring of the performance of the local PV system, proactive identification of actual or potential developing compliance gaps, and ensuring appropriate action is taken (including escalation to local senior management and/or the PVCCL, as applicable) to prevent or resolve compliance issues.
  • Partners with affiliate and global functions to advance the impact and contributions of pharmacovigilance in the local context - "Safety Business Partnership (SBP)".

Key Responsibilities

  • Establish and maintain a local PV system in context with and as defined in the wider global Roche PV system
  • Pharmacovigilance System Master File (PSMF)
  • Management of Individual Case Safety Reports (ICSR)
  • Management of aggregate reports
  • Risk management and safety communication
  • Oversight of studies, programs, and other business activities
  • Safety labelling and PV commitments
  • Partnering and Enablement - "Safety Business Partnership (SBP)"

Qualifications, Experiences, Competencies

Qualifications

  • Healthcare professional (medical degree preferred).
  • Other life science backgrounds with significant experience relevant to PV in an affiliate setting may be acceptable, provided medical oversight is ensured.

Experiences

  • Significant experience relevant to PV in an affiliate setting (ideally, at least 3-5 years).
  • Experience in other affiliate medical functions (e.g., Medical Affairs, Clinical Operations, Medical Information).

Competencies

  • Thorough knowledge of pharmacovigilance and a good understanding of quality principles.
  • Ability to design, implement, and maintain PV processes and PV oversight systems that are straightforward, effective, and efficient.
  • Sound understanding of the pharmaceutical industry and the environment in which it operates, including the development, value chain, and lifecycle of medicinal products.
  • Ability to constructively engage, influence, collaborate, and partner with multiple stakeholders.
  • Strategic, innovative, long-term, outcome oriented thinking
  • Excellent communication skills including proficiency in verbal and written English language.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche Indonesia is located in the business district of Jakarta. We have 3 divisions: Roche Pharmaceuticals, Roche Diagnostics and Roche Diabetes Care with more than 700 employees - and we keep growing. We've been in Indonesia since 1972 to answer the need for highly differentiated medicines and diagnostics for personalized healthcare. Our commitment is to continue providing accessible innovative treatments and solutions for every Indonesian patient and to continuously 'Doing now what patients need next'.

Roche is an Equal Opportunity Employer.

Job Level:

Individual contributor

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Job Detail

  • Job Id
    d799e1a44e617076
  • Location
    id
  • Company
  • Type
    Private
  • Employment Status
    Permanent
  • Positions
    Available
  • Career Level
    Experience
  • Gender
    Male/Female

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