Senior Pharmacovigilance Scientist at Roche Products Limited (2023-01 – Present)
- Serve as Subject Matter Expert (SME) for ICSR Medical Review processes, ensuring consistent application of causality, labelling, and seriousness assessments including case narratives.
- Conduct continuous safety data evaluations and trend analyses across assigned product portfolios to detect and present actionable findings to Business Process Owners and safety governance teams.
- Lead updates and maintenance of the Always Serious List (ASL) in line with MedDRA biannual updates, ensuring regulatory compliance.
- Contribute to strategic projects, including the Automatic Labelling Project, supporting data standardisation and automation in safety databases.
- Collaborate closely with cross functional teams (Clinical Safety, PVIS, SRAM etc.) and global process owners (GPOs/BPOs) to strengthen data flow management, compliance, and inspection readiness.
- Served as POD Lead backup, overseeing workload distribution among team members and providing audit and inspection support to ensure compliance and continuity of operations
Senior Pharmacovigilance Scientist at Roche Products Limited (2020-06 – 2022-10)
- Acted as Subject Matter Expert (SME) for Literature processes, overseeing literature validity checks, case processing, and ensuring consistency across global and local intake teams.
- Acted as Subject Matter Expert (SME) for Medical Review process, overseeing labelling, causality and seriousness assessments.
- Collaborated with cross-functional teams (PREDi, PVP and PVIS) to maintain the global literature product list as per current PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs) to ensure accurate and comprehensive literature searches review.
- Provided guidance to vendors on day-to-day process queries, while leading process improvement initiatives and conducting monthly data reviews to ensure consistency, compliance, and quality.
- Led the successful outsourcing of the global Literature Mailbox to a vendor, providing hyper care support during transition and implementing process efficiencies that improved operational performance while maintaining regulatory compliance.
- Contributed to the implementation of the new POD operating model by leading brainstorming sessions and supporting initial setup to achieve more efficient team workflows.
Clinical Safety Scientist at GlaxoSmithKline (GSK) (2017-12 – 2020-06)
- Conducted scientific review of literature articles for validity assessment and ensured accurate entry of ICSRs into global safety databases in compliance with SOPs and regulatory requirements.
- Authored and reviewed narratives and summary reports, ensuring scientific accuracy and regulatory alignment.
- Led complex database reconciliations (Drug Safety Triager) and collaborated with external partners (Kinapse/QSI) to ensure accuracy and completeness of safety data.
- Mentored and quality-checked vendor teams (TCS), preparing them for certification and improving overall case processing efficiency.
- Managed the global literature mailbox and spontaneous report mailbox, resolving complex queries from LOCs (local operating companies) and vendors.
- Acted as CMG (Case Management Group) Literature point of contact, supervising vendor transitions and ensuring continuity of safety reporting activities.
Patient Safety Specialist (UK Safety) at Novartis Pharma Ltd. (2017-05 – 2017-12)
- Managed multiple data sources (mailboxes, hotline, social media) to capture, evaluate, and report potential safety information in line with regulatory requirements.
- Triage and expedited reporting of ICSRs to health authorities (MHRA, EMA, HPRA), ensuring compliance with strict regulatory timelines.
- Supported the GSK–Novartis transition by conducting bi-weekly reconciliations of safety data, maintaining accuracy and continuity during integration.
- Collaborated with global pharmacovigilance teams to identify and resolve local process gaps, ensuring alignment with global standards.
- Developed and reported weekly safety metrics, identifying cases requiring follow-up (TFUQs) and coordinating with global PV teams to ensure timely action.
Clinical Safety Scientist at GlaxoSmithKline (GSK) (2013-12 – 2017-05)
- Reviewed, extracted, and entered safety data from literature sources into global databases, ensuring compliance with SOPs and regulatory timelines.
- Conducted case processing activities during the transition from Oceans to ARGUS, ensuring data accuracy and operational continuity.
- Performed follow-up activities with authors and LOCs to confirm case validity and regulatory reporting requirements.
- Mentored and trained new team members, delivering presentations and refresher training to address quality trends.
- Carried out quality control reviews of case processing work, improving overall team compliance and efficiency.
Pharmacovigilance Scientist at AbbVie Ltd. (2013-07 – 2013-11)
- Entered and reviewed ICSRs from clinical and post-marketing sources into the local safety database, ensuring regulatory compliance.
- Evaluated safety data from market research programs (e.g., HUMIRA Lead) and escalated potential safety reports.
- Partnered with healthcare professionals, medical representatives, and patients to address safety concerns.
- Performed monthly reconciliations with medical representatives, medical information teams, and third-party vendors to ensure data consistency.
Senior Pharmacovigilance Associate at Arrow Generics Ltd. (2010-10 – 2013-06)
- Led the project to register the company as a Marketing Authorisation Holder (MAH) with EudraVigilance, enabling electronic ICSR submissions.
- Coordinated and executed mandatory EMA testing pre–go live, ensuring successful transition from paper to electronic submissions.
- Authored and implemented SOPs and work instructions, supporting compliance with regulatory reporting requirements.
- Acted as team lead for regulatory submissions, overseeing reporting of all ICSRs to EMA, MHRA, and other health authorities.
- Monitored acknowledgements for ICSR submissions, resolving failed submissions, and raising CAPAs for missed or incorrect reports.
- Produced monthly compliance reports to track ICSR submissions and ensure alignment with regulatory standards.
Drug Safety Associate at Ipsen Biopharm Limited (2010-06 – 2010-10)
- Entered and reviewed adverse event case reports from post-marketing and clinical trial sources into the global safety database (ARISg).
- Raised and managed follow-up SAE queries with investigator sites and clinical research associates to complete case data.
- Generated follow-up letters to obtain critical safety information, ensuring timely case closure.
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