Director of Pharmacovigilance Job – London

Hendre Moolman at CK Clinical is currently recruiting for an Associate Director of Pharmacovigilance to join a successful pharmaceutical company in Greater London.

The role:

As Associate Director of Pharmacovigilance you will support developmental programs, both regionally and internationally. It is envisaged that these will largely be in Phase III; with flexibility to include earlier or later stage development. You will also be responsible for the oversight of signal detection and risk management activities for designated global/regional products, together with global safety lead responsibly as appropriate. You will have line managing responsibilities for junior physicians and/or scientists.

Further responsibilities:

  • Expectation of delegated tasks from Senior Group Medical Director on a defined and ad hoc basis with the flexibility of mind-set and time resource this entails. This will include representing the Senior Group Medical Director and occasionally head of department at meetings etc.
  • Ensure safety profile, including any emerging safety concerns and risk: benefit evaluation for ‘own’ compounds with input for other compounds as needed.
  • Serving in a leadership capacity for complex and strategically important developmental programs
  • Responsible for development of documents and for negotiation with Regulatory authorities on safety matters involving these compounds. This includes but is not limited to: direct interaction with Regulatory authorities, authorship of safety summaries to support changes to the PI/SmPC, significant contribution to MAAs and NDAs, authorship of Executive Summaries on special safety topics, authorship of Integrated Analyses of Safety (IAS) for CTDs.
  • Training and mentoring of Pharmacovigilance Physicians and Specialists
  • Review and oversight of safety data, both non-clinical and clinical
  • Review and/or sign off of protocols, SAPs, clinical study reports, IBs, IMPD and other documents developed for submission to regulatory authorities
  • Interactions with external experts and regulatory agencies and partner/co-development companies
  • Review of safety data and participate in dose escalation decisions
  • Authorship and sign off of Safety Monitoring Plan/Risk Management Plan
  • Review and/ or generation of monthly safety reports for signal detection
  • Lead data analysis and writing of regulatory submission documents, for license application and variation activities and for safety issues and questions from regulators
  • Direct the set up of safety procedures and development of safety exchange agreements for co-development projects
  • Review of all local cases for the designated products
  • Assist with activities related to local regulatory agency interactions if required
  • Working knowledge and familiarity with clinical protocols, SAPs, clinical study reports, RMPs and periodic reports for the product
  • Member of safety working group and participate in compilation and review of data to be used by the group
  • Maintain professional knowledge and accreditation by active participation in continuing medical education activities

 

The ideal candidate:

To be considered for this Associate Director of Pharmacovigilance position, you will have the following skills, experience and qualifications:

  • Qualified physician (GMC registered)
  • Proven experience in pharmacovigilance, clinical research or clinical development
  • 2-3 years clinical experience with patients following post-graduate training with significant knowledge of general medicine
  • Knowledge of principles of epidemiology and statistics.
  • Critical thinking and analytical skills and ability to make high level decisions
  • Excellent oral and written communication skills including ability to present to large internal/external groups
  • Good level of computer literacy with Microsoft applications

How to apply:

For more information or to apply for this Associate Director of Pharmacovigilance position, please contact Hendre Moolman at CK Clinical on +44 (0) 1438 870 023 or email hmoolman@ckclinical.co.uk. Please quote reference CL22745 in all correspondence.

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