Rakesh Sewal

Drug Safety Associate @1205

CA

Triage, Prioritization, managing departmental adverse event (AE) reports intake from spontaneous sources, clinical trials, studies and marketing activities (including healthcare professionals and consumers) in accordance with company standard operating procedures (SOP) and guidelines for maintaining regulatory compliance• Case entry in Global safety database, SCEPTRE, determination of seriousness, expectedness, Lack of efficacy• Track AE reports due to Health Canada, Global Medical Organization and affiliates to ensure compliance as per SOP, PV agreement and regulations• Reconciliation with internal and external business partners, AE Data management, Document archival• Training departmental personnel, new team members for Drug Safety, Follow up, compliance process• Answering medical enquiries in coordination with Medical Information team, Global Medical Organization of Johnson & Johnson• Liaise with internal and external business partners, HCPs and consumers to obtain complete case information and documentation• Strategic planning for process improvement for efficiency in coordination with the team.• Providing ad hoc support for drug safety related requests• Liaise with compliance team for and CAPA (Corrective Action/Preventative Action) development.• Adhoc leading support to follow team for troubleshooting• Responding to queries and international affiliates as required for operational (e.g. queries), compliance and/or safety functions

Post Graduate Institute of Medical Education & Research, Chandigarh

Doctor of Philosophy (PhD), Pharmacology

DIPSAR ( University of Delhi) New Delhi

M Pharmacy, Pharmacology

McMaster University

Certified Clinical Research Associate, Clinical/Medical Laboratory Science/Research and Allied Professions

Maharshi Dayanand University, Rohtak

B Pharma, Pharmaceutical Sciences