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 PV-SOP management (includes Affiliate QMS documents managed by GDS): Partner with the PV quality systems lead to perform periodic review/ update of GDS/ Affiliate pharmacovigilance procedural documents and templates. Support GDS Subject Matter Experts (SME) with Master Control operations and procedural update training. Maintaining PV vendor’s SOPs/WIs records . Maintaining PSMF annexes as related to the PV vendors and organised data collection programmes . Reviewing contract requests and assessing the need for safety reporting requirements language inclusion in the contract or a standalone PVA· Support preparation of safety management plans for specific studies/ vendors· Represent GDS at periodic Product Quality Complaint trending meetings· Maintain organised data collection programmes (MRP, PSP etc.) trackers. Supports PV Alliance Management operations tracking of PVA/ SDEA obligations and delivery of partner/ PV vendor mandatory training. Maintenance of business partner/ distributor lists, Prepares compliance metrics for PV partners and license partners as per the individual agreements. Coordinate periodic review and maintain the local literature search strategy in collaboration with the local medical directors, Support Pharmacovigilance agreements (PVA) authoring.

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 timelines• 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.• Liaising with the Patient Access Scheme administrators to address RMP deviations.• Preparation, review and distribution of RMP materials in accordance with EU GDSRM.• Tracking and (re) registration of all pharmacies administering RMPInternal affiliate development• To assist with training of the affiliate organisation and associated third parties on safety data reporting requirements and Risk Management Plans.• To provide advice on pharmacovigilance issues to other internal departments, or regional project teams.• To prepare/review/present pharmacovigilance documentation for internal and external customers and to represent the affiliate Drug Safety and Risk Management Department on a company level under the supervision of the Drug Safety and Risk Management Manager.• To mentor and develop more junior colleagues, ensuring development of the Drug Safety and Risk Management function to add value to the affiliate organization• To maintain current awareness of the safety profile of the development and/or marketed company portfolio and their most relevant competitors• To maintain current awareness of the current product labeling on all Celgene’s products (IB, National, SPC, Core label, US PI)

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• To assist with training of the affiliate organisation and associated third parties on safety data reporting requirements• To capture, follow-up and ensure the appropriate persons within Celgene are notified of locally reported Product Quality Complaints.

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• Expedited reporting to regulatory authorities and partners

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.