Postdoctoral Researcher

• Mar 2022 - Present

Research Assistant

• Nov 2018 - Mar 2022

Pharmacovigilance Specialist

• Jun 2017 - Apr 2018

- To be responsible that 457 pharmaceutical products risk management and safety management -Executing the Pharmacovigilance management process (including prepare the PBRER, line-listing of local, reconciliations Affiliates) -Managing licensees SDEAs, Contractors, specific processes and safety documentation) in Pharmacovigilance activities related to the products powered by SAP . - Preparating of PBRERs/ACOs for the product(s) under national registration for which ADEKA is MAH ,Maintaining /Updating to the Reference Safety Information, Maintaining /Updating Agreement Searching the Local medical/scientific literature -Reporting and Follow-up to Pregnancy ICSRs, Using to theMedDRA, Show less

R&D Specialist(Medical Device)

• Jul 2016 - May 2017

- To be responsible with each of 119 products which contains medical devices, cosmetics and supplements grading to manage process both of trading, manufacturing, APIs provide and exporting as convenient that local MoH and their responsible authority (EU,UAE). - Prepearing the proforma invoice and managing the supplier process within SAP FF, PP FM modules mantained following up the complaints from to pharmaceutical companies which located in Local, UAE,EU. - Providing support on preparing and reviewing core dossier of pharmaceutical companies which located in Local,UAE,EU. Supporting to major market regulatory approvals to pharmaceutical companies which located in Local,UAE, - Supporting the communication and relation for the trade of high percent of pharmaceutical companies which located in Local,UAE,EU. - Searching new APIs and marketing analysis for the new Projects. Providing the quality APIs and intermediates to pharmaceutical companies which located in Local,UAE,EU. - Supplying the APIs to pharmaceutical companies which located in Local,UAE,EU. Managing the logistic and operational process to Contracting manufacturer/ Pharmaceutical Companies within Local,UAE,EMA and FDA. Show less

RA Spec.& QPPV

• Oct 2015 - Jul 2016

ESTEVE which is headquartered in Barcelona, Company members relating with one of them is Pensa Pharma. Job Description: - To Prepare of products Licence transfer documents,co-marketing dossier and licence renewal documents with approved PBRER dossier for approved by MoH -To be prepared the CTD documents from module 1 to 3 with last revised formatted -To it presenting the documents to the MoH for approval , -To responsible the Medical governance for approval mentioned congress,meeting symposium, registration the doctor who is provided to support to about announced by MoH Show less

Regulatory Affairs and Pharmacovigilance Specialist

• Jan 2014 - Oct 2015

TEKA is one of the distributor company of SIFI S.p.A , Vivacy and I.f.c Cantabria . - Registering to the MoH e-Submission data module which are cosmetic products, supplements - Registering and maintaining of medical devices in TITUBB ,class II filling material, - Preparing the drug approval dossier about the variations/ licence renewal, - Preparing PBRER within pharmacovigilance division , - Providing "stability datas" related to required manufacturer tests, - Giving the pharmacovigilance and product training related to office personnel - Delivering the ICSRs as CIOMs to Regulatory Authorities for verification and reconciliation, - Preparing and submitting reimbursement dossiers Show less

Vaccine deparment trainee

• Sep 2013 - Jan 2014

- To provide required documents and informed to Medical dept. head "Dr. Devrim Ulusoy" as being support, - To coordinate with PM Pharm.Ece Bilge before the event/organization/ congress - To approve mentioned doctor or member of mentioned association related vaccines based on considering specialist that is own branch, - To attend required E-learning and certificate programming considering to the schedule that prepared by responsible executive, - Observing and learning distribution of "Cold Chain Products" related to the Vaccines Show less

Regulatory Affairs Intern

• Nov 2012 - May 2013

I have been working with "Pharm. Burcu Sen" , she was my supervisor. Regulatory Affairs Department Responsibilities that gained: - To observe while the initial files of new products prepare in CTD format. - Preparing analysis files to providing analysis equipment and finished drug products to Health Authority for analysis. - Controlling that Update SmPC and PIL in line with Health Authority regulations - Providing to support prepare the documents that performs " Finished Product" quality releases to the market in connection with Third Party Distributor. - Observing to distribution of "Cold Chain Products (From Third Party Logistic (TPL)" to customers) that relevant SOP/WI are applied. - Understanding and Check up approval SOP revisions. - Supporting to prepare the Release back-orders files in collaboration with the TPD (Inspect and release all drug products before returning to saleable stock - Approve the further release of returned drug product)(via SAP SD module) - Providing to support that preparing the GMP submission files in line with Health Authority regulations. - Ensuring support to preparing the Clinical Research Files Show less

Drug Development Research Programme trainee

• Jun 2012 - Sep 2012

I've been attended internship programme in Glasgow Cancer Research Center (connect to glasgow university) in 2012. This programme accordance to the Glasgow University. My supervisor is Phd Manosh Paul within Glasgow University Pharmaceutical Technology Department. Acquired skills - Characterising Nanopharmaceutical and biotechnological molecule based on QbD to treat breast cancer, - Producing the layer of composition that existed in nanopharmaceutical within controlled release dosage forms and bioavailability, - Monitoring the patient pharmacokinetic activitiesin required time intervals after the drug applicated, Show less

Trainee

• Jan 2011 - May 2011

I attended International Pharmaceutical Student Federation while I am in Munich/Germany, . The organisation is provided to me the job opportunity in Boehringer Ingelheim.I worked with "Claudia Panitz" , the RA project coordinator related to the Clinical Trials who contacted with me. Responsibilities: -To learn the essential regulatory requirements for clinical research in Europe and key US requirements which impact on trials in Europe. -To learn how that highlight the major differences between the Regulation and the current Directive. -To apply practical advice it that be concerning the "new Clinical Trial Regulation" Show less

PHARMACOVIGILANCE&REGULATORY AFFAIRS TRAINEE

• Jun 2010 - Sep 2010

-To worked in Rregulatory affairs department with Dicle Balbay ( pharmacovigilance is available within the department also) in Turkey Regional Office . -To prepare CTD dosiers and to learnthe MoH letter answering that is about variotion types, -To prepare first PSUR(Periodic Safety Update Report), - To report the ADRs to the MoH and -To Be supporting to prepare CTD dossiers. -To worked in Rregulatory affairs department with Dicle Balbay ( pharmacovigilance is available within the department also) in Turkey Regional Office . -To prepare CTD dosiers and to learnthe MoH letter answering that is about variotion types, -To prepare first PSUR(Periodic Safety Update Report), - To report the ADRs to the MoH and -To Be supporting to prepare CTD dossiers.