The Cutting-Edge Pharmacovigilance Services at PhaMe
Eman Elsherif works as a Pharmacovigilance Specialist at Biocodex Pharmaceutical and Medical Services (PhaMe). She describes here the diversity of the pharmacovigilance tasks performed by a Pharmacovigilance Specialists at PhaMe.
The Pharmacovigilance Specialist is a multi-talent
“When I had completed my five-year bachelor’s degree program in the pharmaceutical sciences in May 2002 and after gaining a breadth of experiences working in different aspects in the pharmaceutical industry over the years, I joined PhaMe as pharmacovigilance specialist in August 2020”, tells Eman.
“I am responsible for a broad range of post-marketing pharmacovigilance activities – for Biocodex as well as other pharmaceutical companies in Finland”, she continues.
The main task of a Pharmacovigilance Specialist is to ensure that all pharmacovigilance (PV) activities are compliant with the regulations. The PV activities include maintaining the pharmacovigilance system master file (PSMF), managing of individual case safety reports (ICSRs), leading the triage process, data entry and quality review of drug safety reports using the MedDRA code as well as writing required narrative texts.
Further, Eman uses multiple PV databases e.g. Argus, Aris, SafetyEasy, manages e-transmission of ICSRs via EVWEB and the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD). Also, she monitors the EVWEB and screens the global literature to detect signals for the drug safety which important e.g. to update the periodic benefit risk assessment report for marketed medicinal products.
Quality comes with pharmacovigilance
In addition to pharmacovigilance, quality-related tasks are part of the PV specialist’s daily work. Eman is supports the quality management system of Biocodex by handling deviations and corrective and preventive actions as well as coordinating and supporting during internal and external audits. Also, she regularly reviews and updates the company’s standard operating procedures and is currently developing the cosmetovigilance guidelines.
Biocodex PhaMe – a high-impact service provider in the Nordics
The pharmaceutical industry has been facing increasing challenges in recent years to reduce healthcare burden and maximize productivity and efficiency – in world that is yet to recover from the COVID-19 pandemic. A particular concern has been the challenge to balance R&D spending with acceptable return on investments. Therefore, outsourcing presented an opportunity for the pharmaceutical industry to meet such needs against a background of rapidly changing and increasingly challenging global landscape.
In this context, PhaMe is strategically positioned to become a high-impact service provider in the Nordic region, given the capacity to provide cutting edge on-demand services, improve operational efficiency, and widen geographical presence.
“I believe PhaMe has more to offer than cutting operational costs, given the constant pursuit of achieving the fine balance between quality and efficiency. This, in my opinion, would allow PhaMe to become more of a long-term strategic partner of regional and international pharmaceutical companies rather than a service provider”, expects Eman for the future.
The service portfolio of PhaMe
With our qualified professionals, PhaMe can provide full solutions for any of the following activities with 100% compliance with the regulations and in a cost-effective manner:
- Food supplements and cosmetics
- Market access
- Quality management
- Medical affairs
- Medical devices
- Regulatory affairs
- Pharmaceutical wholesaling
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