Director, Drug Safety and Pharmacovigilance

1 day ago

Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time
Job Title: Director, Drug Safety and Pharmacovigilance

Bicycle Therapeutics is a clinical-stage pharmaceutical company developing innovative medicines for underserved diseases. We are seeking a highly skilled Director, Drug Safety and Pharmacovigilance to lead our clinical safety activities and ensure the safe development of our products.

Key Responsibilities:
  • Develop and maintain a deep understanding of the safety profile of our products and relevant strategic context.
  • Lead safety risk management activities, including defining and characterizing the safety profile, risk assessment, and mitigation strategy.
  • Design and implement pharmacovigilance strategies, perform signal detection, and evaluate emerging safety data.
  • Collaborate with cross-functional teams to chair the Safety Surveillance Team, facilitate review of emerging data, and present important safety issues to senior management.
  • Provide expert safety input and review of study-specific documents, including protocols, IBs, IMPDs, and clinical study reports.
Requirements:
  • MD or equivalent degree with experience in clinical safety, pharmacovigilance, and risk management.
  • Good knowledge of relevant regulations, including FDA, EU, and ICH.
  • Ability to understand science and biology, and act without oversight in most circumstances.
  • Strong work ethic, decision-making skills, and ability to manage multiple programs.
What We Offer:
  • State-of-the-art campus environment with on-campus restaurant and Montessori nursery.
  • Flexible working environment and competitive rewards.
  • Employee recognition schemes, annual leave, and pension contributions.
  • Private medical insurance, life assurance cover, and group income protection.

Bicycle Therapeutics is committed to building a diverse workforce that represents the communities we serve. We recognize that diverse and inclusive teams build a stronger and more innovative company. Therefore, all qualified applicants will be considered for employment, and we do not discriminate on the basis of race, religion, color, gender, sexual orientation, age, disability status, marital status, or veteran status.

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