Surag Ghosh

Supervise Pharmacovigilance staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; performance appraisal and professional development guidance; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.

Ensure all serious and non-serious ICSRs (individual case safety report) are processed by the team members as per regulatory timelines and service level agreements. Be updated on all new/changes related to process/conventions/guidelines and ensure the team members are updated on the same.

Review literature search outputs for registered products in the Safety Literature Information Management database on a daily basis. Evaluating the literature search results for the detection of ICSR, other relevant information in relation to the safety profile, Benefit-Risk balance of these products and identification of Potential Safety Observations.

In house CRA responsibilities included: Distributing safety information pertaining to study drugs to sites, office administration, filling e-CRF, archiving study documents. Preparing and maintaining Sponsor Trial Master File. Preparing Investigators Trial Master File.

Site In charge for multiple Clinical trials. Assisting Investigators during Informed Consent stage. Coordination and Point of contact during CRA/project manager visits. Filling e-CRF.

Biotechnology, Biochemistry

Biotechnology, Biochemistry,