This is with further reference to our opening for the position of "Head- Medical & Safety Monitoring-, Department- Drug Safety Risk Management with a Leading Pharmaceutical.

Location : Mumbai

Relevant Experience : Experience as Medical Expert, Assessment of ICSRs, Signal Detection, Safety Reports & Safety Monitoring in Clinical Development.

Roles & Responsibilities :

- Medical review of aggregate reports, RMPs, PBRERs, Clinical Expert Statements.

- Signal Detection & Signal assessment.

- Review of study protocol, CRF, informed consent, Investigators Drug Brochure, Statistical Analysis Plan and other study material from safety Prospective.

- Evaluates and assesses SAEs and AEs, Review laboratory and other safety parameters, Review patient profiles, Review coded terms for medical history, Concomitant medications, Adverse events and Provides medical expertise to project teams during life-cycle of study.

- Medical review of study data and support due diligence.

- Preparation of subject narratives, Review of study reports and other documents, Preparation and /or review of periodic and Interim safety reports.

- Preparation and Review of Medical and Safety Monitoring plans. Execution of the plans working cross functionally with clinical teams.

If interested: Please revert me with your updated CV with following information's :

Current CTC (Fixed CTC + Variable) :

Expected CTC :

Current Location :

Home Town :

Marital Status :

Notice Period :

Neha Shukla

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