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Director, Drug Safety and Pharmacovigilance
2 months ago
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 and pharmacovigilance efforts.
Key Responsibilities:- Develop and maintain an expert 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 ongoing signal detection, evaluation, and periodic review of emerging safety data.
- Collaborate with cross-functional teams to chair the Safety Surveillance Team, facilitate review of emerging data, and assess safety trends.
- Provide expert safety input and review of study-specific documents, periodic and annual safety reports, and investigator communications.
- Ensure timely, compliant, and accurate safety reporting in accordance with regulatory requirements and Good Clinical Practice.
- MD or equivalent degree with experience in clinical safety, pharmacovigilance, and risk management.
- Good knowledge of relevant regulations and proven evidence of effective delivery of high-quality documents.
- Ability to understand science and biology, identify risks, and propose corrective actions.
- Strong work ethic, decision-making skills, and ability to manage multiple programs and coordinate complex deliverables.
- Flexible working environment
- Competitive reward, including annual company bonus
- Medical, dental, and vision insurance for eligible employees and their families
- 401(k) plan with a 4% Company match and immediate vesting
- Eligibility to accrue up to 23 paid time off days per full year worked
Bicycle Therapeutics is committed to building a diverse workforce that is representative of 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.
