Nazish Abbas PharmD, HPM

Managed individual projects through their entire lifecycle within project management software.

Oversaw ICSR and AE management, notifying via Eudravigilance and CIOMS forms for case assessment.

Authored and submitted PSURs, PBRERs, and RMPs while managing XEVMPD.

Conducted signal detection and management to ensure compliance with regulatory standards.

Provided training to colleagues on specific projects as needed and collaborated with suppliers and customers to maintain project efficiency.

Represented Precision Health Consultants Global at stakeholder meetings and workshops.

Contributed to grant writing efforts to diversify funding portfolio.

Designed data collection tools and study methodologies for effective research implementation.

Implemented studies through detailed work plans and timelines.

Supervised field staff to ensure adherence to study protocols.

Analysed field data to derive actionable insights.

Conducted quality assurance checks and authored comprehensive reports.

Managed submission and oversight of grant proposals and manuscripts.

• Managed ICSRs for all Novartis products from clinical trials, post-marketing studies (PMS), Spontaneous Reports (SR), registries, Patient Oriented Programs, etc. Also managed and maintained all relevant PVO databases

• Managed all the activities on safety systems (e.g. ARGUS Affiliate, etc.). Recorded and tracked receipts, submissions and distributions of SAEs, SRs, Investigator Notifications (IN)/SUSARs, PSUR and DSUR in cooperation with all cross functional teams.

• Exchanged relevant safety information with local health authorities (LHA), PVO associates, other functional groups and third-party contractors. Also monitored National Pharmacovigilance Regulations and ensured local DS&E-related RMP commitments are properly documented. Processed literature cases detected locally.

• Ensured proper cross functional reconciliation

• Ensured timely preparation and submission of KPI reports on AE reporting including identification of root cause(s) for late reporting to LHA, development and implementation of corrective action(s) as needed. Supported for and close out of audits, CAPAs and Health Authority inspection

• Developed training materials for Pharmacovigilance and ensured training of CPO associates, field force and third-party contractor, if applicable

Ensured compliance with local Pharmacovigilance requirements within Novartis.

Conducted QC checks of all ADRs and entered QC IDs in Argus, reconciling with stakeholders.

Assisted in audit preparation for regional and global auditors while managing local PV tracking tool.

Submitted CIOMS reports to local health authorities.

Executed literature screening of local medical journals for relevant safety information.

• Acted as Site Owner of COSTA, overseeing distribution and assignment of RMP tasks.
• Managed filing and archiving processes for all RMP-related documentation.

• Collaborated with various business partners to design and implement mobile marketing strategies.
• Created communication strategies to extract valuable customer insights for brands.
• Developed healthcare engagement plans and awareness programmes for Rutgers WPF and Getz Pharma.
• Engaged customers to resolve daily queries through medical interactivity and service support.
• Established and maintained comprehensive FAQs for all brands.

Conducted raw material testing to ensure compliance with quality control standards.

Maintained comprehensive data management and documentation for analysed materials against purchase orders.

Performed sampling of materials in accordance with GMP guidelines.

Calibrated analytical instruments and monitored product stability following established protocols.

Managed operations for solid and sterile products, ensuring adherence to specifications.

Maintained accurate logbooks and Batch Packaging & Manufacturing Record documents to support traceability.