Data Management Lead
2 days ago
Bicycle Therapeutics is a leading pharmaceutical company specializing in the development of novel medicines. We are seeking an experienced Drug Safety Specialist to join our team in Cambridge, UK.
The successful candidate will lead clinical safety activities for assigned compounds, ensuring compliance with global regulations and industry standards. This role requires strong expertise in pharmacovigilance, risk management, and drug safety.
Key Responsibilities:
- Perform safety risk management activities for assigned products, including defining and characterizing the safety profile.
- Lead safety evaluation activities for assigned products, including designing PV strategies and performing ongoing signal detection.
- Provide oversight of clinical safety activities, including review of MedDRA coding and assessment of SAEs.
- Ensure timely and compliant safety reporting in accordance with applicable regulatory requirements.
- Represent the Drug Safety function across various cross-functional teams.
Requirements:
- A degree in medicine (MD, MBBS or equivalent) with experience in clinical safety, pharmacovigilance, and risk management.
- Strong understanding of science and biology, with ability to identify risks and propose corrective actions.
- Excellent team working and leadership skills, with ability to mentor and supervise less experienced members of the Drug Safety Team.
We offer a competitive salary of £80,000 - £110,000 per annum, depending on experience, plus benefits including annual leave, pension scheme, life assurance cover, and private medical insurance.
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