Manager, Regulatory Affairs and Safety (Taiwan)
Biogen
Taipei,Taiwan
4天前

Summary

The Responsible Pharmacist for Pharmacovigilance has the following main functions :

  • As a Responsible Pharmacists for Biogen Taiwan, responsible for oversight of the pharmacovigilance activities of Biogen Taiwan in compliance with local laws and regulations
  • Responsible for regulatory strategy and submission activity in Taiwan, including safety reporting.
  • Acting as sole direct contact with TFDA and in so doing maintaining a good relationship with the authorities.
  • Job Description

    1.Oversight of the regulatory and safety activities of Biogen Taiwan :

  • Act as a Responsible Safety Pharmacist for Biogen Taiwan
  • Oversee the activities of the nominated Deputy Responsible Pharmacist of Biogen Taiwan, as applicable
  • 2.Safety responsibilities :

  • Provide Pharmacovigilance (PV) training to local affiliate staff, PV Operations vendors and service providers, as needed.
  • Collect, document and send safety reports to Biogen Safety and Benefit Risk Management (SABR) according to Biogen SOPs
  • Complete timely local safety submissions as required and in accordance with local regulations
  • Perform follow-up of adverse events as directed by SABR and where necessary to obtain complete and valid safety information
  • Perform reconciliation activities with local service providers and SABR to ensure receipt of all reported safety information
  • Complete local literature searches and screen results for safety information as required by local regulations
  • Stay abreast of local regulations and send notifications to SABR of any changes in regulations affecting PV
  • Review and assess local organized data collection programs for PV risk. Ensure PV language is incorporated into supporting service provider contracts and perform compliance activities related to such programs.
  • Ensure a PV Business Continuity procedure is in place and maintained locally.
  • Provide oversight of local PV activities through completion of periodic SABR reports (e.g. QPPV Report, follow-up tracker etc. )
  • Perform other PV activities that may be required to meet local regulations
  • 3.Regulatory responsibilities :

  • Support regulatory submission activities (including CMC, clinical and non-clinical) for both new drug applications and licence maintenance activities
  • Provide oversight of external vendors for regulatory services, if applicable
  • Development and implementation of regulatory strategies to support the timely introduction of new products and the preparation and review of government submissions to achieve timely and cost effective approval in the specific affiliate
  • Communicate key regulatory intelligence updates to the Regional Regulatory Lead, including interpretation of any risks or strategic advantages
  • Maintaining the product label and the Risk Management Plan (RMP) (where required)
  • Review and approval of label, packaging and artwork, in accordance with local regualatory requirements
  • Review of local promotional materials in accordance with regulatory codes
  • Maintain good knowledge of CMC aspects and local requirements for Module 3, PMF, GMP applications etc
  • Be responsible for Scientific Services, including clear communication of labelling changes within the country
  • Qualifications

    A minimum of 5 years in a similar function in the pharmaceutical industry, including experience in the Taiwan specific quality and compliance environment

    Knowledge of Taiwan legal and regulatory requirements and local codes of practice

    Excellent connections with local health authorities, evidenced through submission and swift approval of MAAs and complex variations, ideally having coordinated pre / post-

    submission meetings between the company and the authority (TFDA).

    PV Experience at least from 3-5 years, preferably in a multinational company; extensive knowledge of local PV requirements (AE collection, ICSR submission, PSUR, RMP, PV in the CT space)

    Knowledge of quality and compliance activities in the PV space (reconciliations, quality checks)

    Experience with writing and developing policies and guidelines

    Education

    Bachelor of Pharmacy with a Masters degree in Pharmacy preferred.

    Mid-Senior Level

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