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Safety Evaluation Manager

Job LocationCambridge
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

Company DescriptionMundipharma is a global (ex-US) network of independent associated companies that research, develop and manufacture innovative pharmaceutical medicines and consumer healthcare products. We are an agile and fast-paced company seeking to increase access tohealth care through programmes and effective partnerships.We are forward-looking and dedicated to bringing innovative treatments to many of the worlds most challenging conditions and diseases including: Pain Management & Supportive Care, Consumer Health, Anti-Infectives, Biosimilars, CNS, Diabetes, Oncology, Ophthalmology,Respiratory and transplantation immunity.We make a difference to patient lives by delivering value to healthcare professionals in 120+ countries across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East.Our guiding principles, centred around Integrity and Patient-Centricity, are at the heart of everything we do. We encourage our people to think differently and our inclusive culture of continuous learning and collaboration make Mundipharma a great placeto work.Job DescriptionReporting to Head of Safety Evaluation, this role acts as lead for execution of Pharmacovigilance (PV) Risk Management, Signal detection and Aggregate report activities within the Global Drug Safety team.Drives efficient management and delivery of overall Risk management activities, by the global Vendor and provides input to decision making around optimal evaluation of the safety profile of Mundipharmas portfolio as part of the Safety Evaluation Group.Responsible for efficient and effective management and delivery of activities relating to product safety evaluation, including but not limited to:

  • Aggregate reports: PSURs, DSURs
  • Global and local Risk Management Plans
  • Signal Detection and management
Management of CCDS, and other safety labelling activitiesAct as a Safety expert for the designated range of products within Safety and as part of cross functional teams.Monitor and Manage Safety Evaluation outsourced partner to ensure the activities are completed on time and with high qualityAct as the contact person for audits/Inspections and ensures inspection and audit readiness for Safety EvaluationParticipate / lead process improvements impacting Global Safety EvaluationQualificationsLife science Graduate (Pharmacist preferred) with 5-8 years experiecne in Pharmacovigilance and with 3 of those years spent in Safety Evaluation

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