Farishta Moshref Email & Phone Number

Princeton, NJ, US

Acts as PV vendor operational point of contact· Support the PV quality systems lead with functional CAPA coordination, trending and tracking – support functional SMEs with quality event investigation, CAPA planning. Accountable for CAPA evidence gathering and CAPA trending/ reporting to GDS leadership and other Amicus compliance committees. · Support with.

Lawrence Township, NJ, US

Summit, New Jersey, US

• Comply to the conditions of the Marketing Authorisation of Celgene Products through preparation, planning and the implementation of Celgene RMP in accordance with local and international legislation and the agreed.
• Set-up and implementation of measures to assess the compliance rate and effectiveness of the RMP
• Consolidation and review of pharmacy audit data including Prescription Authorisation Forms (PAFs)/Audit Forms/Order Forms to be presented within a report for submission to the MHRA and IMB
• Responsible for applying measures to ensure the validity of audit data
• Preparation and review of RMP documentation including SOPs/WPs and RMP reports
• Effectively liaising with the regulatory department and MHRA and IMB to ensure regulatory compliance.

• SAE/AE Case Processing
• To ensure the accurate, timely and complete receipt, evaluation and follow- up of domestic adverse event reports.
• To maintain the local archive of safety reports
• To maintain current awareness of local and global safety regulations
• To ensure compliance with local expedited and periodic regulatory reporting requirements for marketed products and those under development, utilizing ARISg and E2B.
• To contribute to the development and maintenance of corporate policies, standard operating procedures and associated documents on safety data handling.Internal affiliate development

Bourne End, Buckinghamshire, GB

• Processing of adverse event reports from clinical studies, post-marketing studies, spontaneous, regulatory authority and literature report sources
• Assessing seriousness, labelling and expedited reporting requirements.
• Triage incoming reports and write patient narratives
• QR of data entry onto the safety database
• Ensure compliance with EU regulatory requirements
• SAE CAPA tracking and requesting any follow-up information for product quality reports

Nuneaton, England, GB

Vast experience of recruiting, coaching, driving sales, profit and daily accounts.Invaluable ability to work well in a fast pace environment. Acquired GNVQ Level Herbal knowledge qualification. Strong ability to explain product information to clients, demonstrating an aptitude to listen constructively.