Team Lead, Drug Safety

DOCS Global
Cambridge, UK
Closing date
24 Sep 2020

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Clinical Research, Drug Safety
Full Time
Contract Type
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This unique opportunity offers both hands on responsibilities within Drug Safety (Quality Management) while also being involved in Line Management and Operations Management responsibilities for a team of Safety Associates / Specialists.

Job Title: Team Lead, Drug Safety
Location: Cambridge, UK
Duration: Full time employment

Position Summary:
The purpose of Team Lead, Drug Safety is to provide oversight & management for activities required to support the delivery of the required processes assigned to the Safety team including resourcing workload assignments, systems, staff training for both current and new staff, and departmental reporting. Also for supporting the day-to-day workload of the Drug Safety Quality Management team.


People Management Responsibilities:
• Coordinate Drug Safety Team members to ensure delivery on all required KPIs and to the required quality levels.
• Team performance management including establishing goals and objectives and discussing development objectives.
• Conducting 1:1 meetings and monitor performance and conducting performance review and appraisal.
• Operations Management to include approval of timesheets, expenses management, approving leave requests among others.
• Provide inputs to SOPs & manuals.
• Lead & manage training activities for team members
• Manage day to day communication with client as a key point of contact
•Work with DOCS leadership team and senior management to ensure optimal resource and workload management.
• Manage and complete induction/orientation for new hires within the team. Also, ensure that client specific trainings are planned and completed within stipulated timelines
• Responsible for performance metrics management and reporting; review KPIs with senior management.
• Involve in recruitment planning and forecasting

Drug Safety, Quality Management Responsibilities:
• Perform retrospective review of data entry against source document within agreed timelines.
• Maintain appropriate records and audit trails of all ICSR related documents and associated QC/QA checks.
• Collate review data for monthly and/or quarterly reviews to demonstrate quality oversight and support implementation of appropriate corrective and preventative actions.
• Act as quality reviewer/mentor for colleagues progressing through training requirements in QM or case processing teams
• Bachelor's degree (or higher) in a scientific/medical field or demonstrated equivalent experience is required
• Minimum of 5 years of experience in Pharmacovigilance including ICSR processing; Previous ICSR QC experience preferred.
• Excellent database and Medical coding skills (i.e. experience with MedDRA) including ability to perform advance searches
• ARGUS Safety database system knowledge preferred
• Knowledge and experience with safety reporting and regulatory compliance and experience with international safety reporting/regulations
• Strong interpersonal and leadership skills with a demonstrated ability to work independently
• Previous experience in training, coaching, mentoring Drug Safety Associates/Specialists along with providing oversight to their work would be highly desired.
• Any experience in people management roles/functions would be beneficial.

DOCS provides global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry. 


Our Values

At DOCS, we are driven by our core values that guide our culture and support our goal to become a Trusted Partner. Our five core values are:

OUR PEOPLE: We attract, source, develop and retain the best talent to enables us provide world-class people and solutions for our clients.

EXCELLENCE: We never stop looking for new, better ways of working.

ACCOUNTABILITY: We take responsibility for our actions, owning our client’s problems and proactively looking for solutions.

INTEGRITY: Becoming a trusted partner means being honest, respectful and ethically sound, at all times.

OPENNESS: We encourage and facilitate an open and inclusive environment for a diverse global network of employees and stakeholders.

Contact Us
  • 2 Globeside
  • Globeside Business park
  • SL7 1HZ
  • United Kingdom
  • +44 (0) 2380 688500
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