Neneweh Yacoub
Denham Court
Summary
Proven Compliance Partner at Roche in compliance and fostering team collaboration. I've championed quality management and pharmacovigilance oversight for Market Research, Patient Support Programs, Digital Customer Engagement and Listening Activities ensuring continuous audit readiness. At Pfizer, I enhanced process optimisation, showcasing my problem-solving abilities and attention to detail, significantly contributing to operational excellence without compromising compliance standards.
Overview
9
9
years of professional experience
Work History
Compliance Partner - MAP Lead & DiCELA Champion
Roche
Barangaroo, Sydney
11.2021 - Current
- Promoting quality and compliance excellence within the affiliate by embedding quality principles.
- Championing informed decision making based on assessing risk.
- Developing partnerships throughout the organisation to support informed risk taking and ensure readiness and flexibility in adapting to change in the internal and external environment.
- Ensures documentation archiving rules are current.
- Oversees quality, compliance and other activities across areas in Compliance & Risk Management to ensure continuous audit readiness for the affiliate.
- Oversees the management of compliance and process systems and tools, process maps and approval processes that support the optimisation and maintenance of affiliate processes.
- Works in partnership with the Local Quality Responsible (LQR) and the maintenance of the Local Quality Management System (QMS) and its related documents, in alliance with the quality principles outlined in the Global Roche GCP/GVP Quality Manual.
- Provide oversight of pharmacovigilance compliance in the implementation of the Global MAP process and local legislation and processes for Market Research, Patient Support Programs, Digital Customer Engagements & Listening activities.
- Collaborating with the Roche Global teams to write guidance documents to be implemented at local levels in different affiliates
- Involved in the Service Peovider Onboarding proccess ensuring an oversight of their ongoing preformance.
- Works with the business to create new or updated policies and procedures for internal partner and stakeholder input.
Drug Safety Associate
Pfizer
11.2015 - 11.2021
- Manage, triage, and book in AEs accordingly
- Submit reporting to TGA / CARM and study sites
- Prioritization and data entry of case reports
- Preform quality review of processed cases
- Conduct follow up activities as needed
- Monitor patient programs
- Liaising with third party vendors to obtain monthly reports
- Monitor monthly performance reports
- Conduct remediation as result of audit
- Workload management
Education
Bachelor of Pharmacy - with second class honors
The University of Auckland
01.2008
Skills
- Regulatory Compliance
- Quality Management
- Process Optimisation
- Pharmacovigilance Oversight
- Audit Readiness
- Effective Communication
- Team Collaboration
- Attention To Detail
- Problem-Solving Abilities
References
- Caroline Benyamin, Patient Safety Manager, Merck Group, 0432 366 729
- Romel Yousef, Pharmacist / Owner, Fairfield Forum Pharmacy, 02 97260046, 0405 424 548
Languages
- English
- Arabic
- Assyrian
Languages
Arabic
Full Professional
Assyrian
Native/ Bilingual
Timeline
Compliance Partner - MAP Lead & DiCELA Champion
Roche
11.2021 - Current
Drug Safety Associate
Pfizer
11.2015 - 11.2021
Bachelor of Pharmacy - with second class honors
The University of Auckland
Similar Profiles
Victor HenriquesVictor Henriques
IT Business Analyst at RocheIT Business Analyst at Roche
Husniyya Idrisova SalimovaHusniyya Idrisova Salimova
Digital Campaign Delivery Manager at RocheDigital Campaign Delivery Manager at Roche
Bobby BowmanBobby Bowman
Production Operator at RocheProduction Operator at Roche
GENEVA ALCAZARGENEVA ALCAZAR
Sr. Executive Administrator at RocheSr. Executive Administrator at Roche
Mitch BrooksMitch Brooks
Acting Crime Practice Manager at Legal Aid NSWActing Crime Practice Manager at Legal Aid NSW