Job Responsibility

1.  Responsible for the continued safety assessment, evaluation and risk management of DZ products or product groups in various stages of clinical development

2.  Responsible for continuous efficient evaluation of adverse event and all other safety information in order to predict and manage the safety profile of compounds in clinical development through identifying the need for update to reference safety information and drive proactive implementation of risk management initiatives in accordance with regulatory requirements.

3.  Provides consistent communication of safety topics across all regulatory safety documents,

4.  Proactively evaluates the clinical implications of safety data from clinical studies, literature and other information sources in order to predict / establish the safety profile of compounds in clinical development, including employing expert groups and methodologies, modelling and simulation to manage the risk to patients

5.  Supports key contacts with opinion leaders, as needed

6.  Be responsible for the Clinical Safety monitoring and management plan.Activities include, but are not limited to: definition of identified and potential risks with high level mitigation and minimisation; proposals for mitigation minimisation measures; safety go-no go criteria for the clinical programme; response to regulatory safety queries and definition of the risk component of the benefit/risk assessment.

7.  Reviews and endorses the core Patient Risk Management Plan/Core Patient Risk Log.

8.  Provides expertise to the medical content of the safety specification, pharmacovigilance plan and risk minimisation activities in the core Patient Risk Management Plan, Core Patient Risk Log.

9.  Represents PS on cross-functional Clinical Teams and/or Project Teams for developmental and/or marketed products.

10.  Provides medical input to ensuring that risk-minimisation strategies are implemented appropriately in relevant documents such as product reference safety information.

11. Provides strategic and medical input to project specific safety requirements.

12. Reviews and provides technical input and approval for investigator brochures, protocols, informed consents, final study reports and external data monitoring committees as appropriate.

13. Present safety information at clinical investigator and commercial meetings.

14. Provides medical input to regulatory supporting documentation for labelling updates.

15. Provides medical input into Identification and utilization of appropriate sources of information and database searches to retrieve relevant data for evaluation of signals.

16. Provides medical input to deliver accurate and fit for purpose safety evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data.

Education, Qualifications, Skills and Experience

1.  Medical degree (eg MD, MBBS)

2.  At least 2 years of clinical experience

3.  At least 5 years of Drug Development/Patient Safety experience (the majority of which should be in industry in Patient Safety) with clear evidence of delivery

4.  Drug Development Experience and Application of Disease and TA knowledge

5.  Excellence in pharmacovigilance Patient Benefit risk assessment

6.  Good spoken English capabilities