Diligent evaluation and assessment of complex report from clinical development projects as well as post-marketing cases.

Reporting sources includes medical literature as well as from post-marketing surveillence studies.

Ensure high medical quality and compliance with health authority requirements regarding AE/ADR single case handling.

Ensure medical plausibility, consistency and completeness of SADR case reports.

Request follow up information and initiate use of specific product/event-related questionnaire when necessary.

Confirm determination of seriousness, assess drug- product casual association and assign global labelling status (expected or unexpected) in order to achieve the appropriate case reporting status for global distribution for regulatory agency reporting. Consult medical experts within TA group for advice in complex clinical questions.

Medical coding of various case date including all AE and Drug terms. This requires in depth knowledge of present coding system ( MedDRA and WHO-DD) with request to structure and medical content.

Create written company causality comment for ADR case reports in accordance with internal standard and guidelines.

Verification of SAE case evaluation within area of responsibility for conformity with SOPs and operational manuals.

Provide medical expertise and judgement throughout the case-handling process with medical review of individual cases.

Ensure compliance with global and local procedural documents and local implementation of company policies.

Maintain knowledge of the marketed drug currently under litigation.

Take responsibility for appropriate capturing and coding of Adverse events from the source.

Determine medically important events and company causality assessment.

Resolve queries relating to AE coding in MedDRA,help in constructing medically sound narratives.

Maintain communication with the Global Safety Physician.

Provide missing causality for clinical trial and solicited cases.

Pharmacovigilance in evaluation of serious adverse events in accordance with regulatory requirement for reporting and execution of a high quality, accurate and timely case evaluation process within a therapeutic area.