Pharmacovigilance and Regulatory Affairs Specialist

14 hours ago

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

Chugai Pharma Europe is a leading regional business and subsidiary of Chugai Pharmaceutical Co., a renowned Japanese research-based pharmaceutical company.

We are seeking a highly skilled Pharmacovigilance and Regulatory Affairs Officer/Junior Officer to join our team in London, with flexibility for remote work.

Key Responsibilities:
  • Assist the Head of Chugai Pharma Europe Pharmacovigilance department in data triage, processing, and submission of adverse events and associated activities, collaborating with Chugai Japan (HQ) on a daily basis.
  • Provide regulatory intelligence, advice, and support to CPE (Development Division and Commercial Division) and Head Office (Chugai Japan) as required.
  • Ensure 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 European legislation.
  • Support Regulatory and Pharmacovigilance Department with a 50/50 split, requiring flexibility and initiative to manage time effectively.
Requirements:
  • Experience working in the pharmaceutical industry or relevant area.
  • Effective training and presentation skills.
  • Proficiency in English, both written and verbal.
  • Proficient in PowerPoint, Excel, and Word.
  • Knowledge of European/Global pharmacovigilance regulations.
What We Offer:
  • Line management from Pharmacovigilance department head and dotted line to Regulatory.
  • Small percentage of travel when required for meeting purposes.
  • Assistance with contract management for new or ongoing contracts related to Pharmacovigilance and Regulatory activities.

We are committed to providing a dynamic and supportive work environment that fosters growth and development. 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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