ProClinical is partnering with a leading global biotechnology company working within the fields of neurodegenerative diseases, haemophilia and autoimmune disorders. This organisation is seeking an Associate Director, Drug Safety Surveillance, to join their team in Greater London.
As a leader in the Safety Surveillance and Aggregate Reports group of Global Safety Regulatory Sciences (GSRS), the Associate Director will oversee and manage all Pharmacovigilance activities for a group of products, including aggregate reporting of all products within the product group, overseeing signal management activities for the assigned group of products, overseeing management responses to ad hoc regulatory responses, overseeing literature reviews/management for safety findings, and overseeing clinical trial safety activities for assigned products.
Job Responsibilities:
- Acting as lead PV Scientist for a group of products, as well as managing and mentoring PV Scientists, Senior PV Scientists, and PV Coordinators assigned to products within the Associate Director's designated product group.
- Monitoring resourcing for all assigned products and manages or reassigns tasks/projects across assigned programs and staff.
- Hiring, training, mentoring, and managing staff within their PV Sciences product group.
- Leading initiatives for process improvement.
- Collaboration with the PV Sciences group, other company staff, and cross-functional groups to develop, implement, and maintain processes that are compliant with global PV regulations, improve efficiency, and lead to consistent work processes across assigned product groups considering cross-program practices.
- Understanding, interpreting, analysing, and clearly presenting scientific and medical data in verbal and written format, including intermediate understanding and application of medical concepts and terminology; mentoring others to develop these skills and serving as a leader within the PV Scientist team.
- Overseeing substantive projects such as signalling, authoring of aggregate data reports, and responses to regulatory agency requests performed by direct reports; overseeing and mentoring less experienced PV Scientist staff.
- Acting as a Subject Matter Expert in Pharmacovigilance and drug development, including a knowledge of applicable clinical trial safety regulations and post-marketing safety regulations.
Skills and Requirements:
- A Bachelor's degree in biologic or natural science, or health discipline. An Advanced Degree, such as a PhD, MPH, NP, PharmD, etc, is ideal.
- At least 8 years of Pharmacovigilance experience, including management experience.
- At least 3 years of experience with aggregate safety reports, such as DSURs, PBRERs, and RMPs.
- Demonstrable experience with troubleshooting and processing issues.
- Capable of working in a team, analysing, and working with attention to detail, process and prioritise sensitive complex information, and solving problems.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency in MS Office.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Kevin Hansberry at +44 207 440 0636 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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