Pharmacovigilance and Regulatory Affairs Specialist

15 hours ago

London, Greater London, United Kingdom Chugai Pharma Europe Full time
Job Title: Pharmacovigilance & Regulatory Affairs Officer/Junior Officer

Chugai Pharma Europe is seeking a highly skilled Pharmacovigilance & Regulatory Affairs Officer/Junior Officer to join our team in London. As a key member of our Regulatory and Pharmacovigilance Department, you will play a crucial role in ensuring the safe and effective use of our pharmaceutical products in the European market.

Job Purpose:
  • To assist the Head of Chugai Pharma Europe (CPE) Pharmacovigilance department in ensuring the data triage, processing, and submission of all adverse events and associated activities, collaborating with Chugai Japan (HQ) on a daily basis.
  • Member of EU Regulatory Affairs Department providing regulatory intelligence, advice, and support to CPE (Development Division and Commercial Division) and Head Office (Chugai Japan) as required.
  • To ensure that all pharmacovigilance and regulatory activities are conducted in accordance with Chugai Global SOPs, Work Instructions, and Regional/Local SOPs, Work practices, Guidelines on Good Pharmacovigilance Practice (GVP), and regulatory requirements of European legislation.
  • The role is within the Regulatory and PV Department supporting both functions on a 50/50 split, however, flexibility and initiative required to manage time effectively.
Key Responsibilities:
  • Participate and contribute to international departmental and company-wide meetings.
  • Responsible for meeting organization and minutes within the Regulatory and Pharmacovigilance teams.
  • Small percentage of travel when required for meeting purposes.
  • Adheres to and operates within the company guidelines and APBI Code of Practice appropriate to job role.
  • Assist with contract management for any new or ongoing contracts related to Pharmacovigilance and Regulatory activities.
Pharmacovigilance Responsibilities:
  • To be responsible for and to assist day-to-day ICSR processing of the reports directly from UK, France, and Germany, including triage and assessment and follow-up activities, ensuring a high standard of data integrity.
  • Prioritization of individual case safety report processing, identifying those cases requiring to be submitted to regulatory authorities and submission according to both regulatory requirements and Chugai SOPs.
  • Assists in ICSR compliance management, performing weekly/monthly data reconciliation both locally and regionally and occasionally with external partners.
  • Responsible person for archiving, ensuring that all documents are stored according to company SOPs and WI or local conventions.
  • Responsible for the preparation, review, and update of the pharmacovigilance SOPs.
  • Contribute to the preparation of aggregate reports.
  • Responsible for maintaining local literature search strategies.
  • To provide pharmacovigilance awareness training to all UK staff and external contractors and affiliates as required and act as local training coordinator with direct communication to the global training coordinator.
  • To collaborate with France and Germany affiliates on an ongoing basis to ensure data quality and integrity across the European Pharmacovigilance department.
Regulatory Affairs Responsibilities:
  • Participate in filing and archiving activities and complete regulatory trackers for the regulatory team as required for both marketed and development products.
  • Manage systems access for internal and external systems.
  • Participate in drafting, review, and revision of regulatory SOPs, WPs, or other documents applicable to the company.
  • Contribute to Master Data Management of Product Information with support of and training from RA and PV (including making Extended Eudra Vigilance medicinal product dictionary (XEVMPD) submissions to European Medicines Agency (EMA) in Lorenz drugTrack).
  • Support the RA team with projects related to development and marketed products as needed.
Qualifications:
  • Essential Criteria:
    • Experience working in the pharmaceutical industry/relevant area.
    • Strong interpersonal skills.
    • Effective training and presentation skills.
    • Capable of managing time effectively and working independently to meet deadlines.
    • Detail-oriented.
    • Proficiency in English both written and verbal.
    • Proficient in PowerPoint, Excel, and Word.
  • Desirable Criteria:
    • Knowledge of European/Global pharmacovigilance regulations.
    • Experience handling adverse events – triage and processing (e.g. Argus Safety Database).
    • Document maintenance experience.
    • French/German as additional language.

Chugai Pharma Europe is an equal opportunities employer and welcomes applications from all qualified candidates. If you are a motivated and detail-oriented individual with a passion for pharmacovigilance and regulatory affairs, we encourage you to apply for this exciting opportunity.

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