Hendre Moolman at CK Clinical is currently recruiting for an Associate Director of Pharmacovigilance to join a successful pharmaceutical company in Greater London.
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.
- 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 email@example.com. Please quote reference CL22745 in all correspondence.
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