Divya P. Email & Phone Number

Sydney, New South Wales, Australia

Sydney, New South Wales, Australia

Sydney, Australia

-Responsible for all aspects of risk management plan (RMP) development, maintenance, and implementation for Alexion products in Australia, New Zealand, and designated countries in the APAC region.-Ensured a high standard of partner and third–party oversight of all RMP related activities, including the collection, review and evaluation of Key Performance Indicators (KPIs) for implementation of additional risk minimization measures and effectiveness checks.-Coordinated the safety-related aspects of the regional post-marketing safety surveillance studies including obtaining, formulating and reviewing data utilised in the compilation of these reports and ensuring regulatory commitments and reporting timelines were met.

Australia

Safety scientist (global PV) for Roche, Basel. Responsible for carrying out pharmacovigilance and risk management activities for assigned products by: • Contributing to pharmacovigilance planning for designated products by preparation of safety surveillance strategy and highlighting and tracking potential issues• Supporting the preparation and maintenance of risk management plans and risk mitigation activities. • Preparing/ reviewing periodic safety reports (PSUR/PBRER, DSUR) in accordance with regulatory requirements.• Supporting the preparation and maintenance of safety sections of the drug labels.• Conducting/supporting signal detection, validation and evaluation, literature review.• Authoring and reviewing drug safety reports (issue work-ups), for signals and health authority requests.• Narrative and CSR review

Chandigarh Area, India

Performed routine signal detection for the product through review of line listings (mortality, SUR, special populations, off-label use, lack of efficacy), monthly literature and disproportionality alerts. Authored and performed medical review of narratives for inclusion in Clinical Study Reports - for medical cohesiveness.Medical review and query resolution for Individual Case Safety Report (ICSR) processing team.

Chandīgarh Area, India

Mohali, India

Meerut Area, India

Various

Doctor Of Medicine - Md, Internal Medicine Residency Program

Mbbs