Experience

hameln pharma ltd

• United Kingdom
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• • Apr 2020 - Present

  writing PSURs and periodic safety assessment reports including signal management, clinical overviews and addendums; new product development -preparation of Prescribing Information (SmPC &PIL), risk management plans (RMPs), bridging reports, similarity reports, handling RFIs and clinical aspects for big DCP procedures; benefit-risk assessment for type II variations (addition of new indications based on literature data) patient risk assessments for batch specific variations;

• • Jan 2017 - Mar 2020


LOCUM PHARMACIST
• United Kingdom
• Pharmacist

  • Apr 2015 - Dec 2016


Alliance Pharmaceuticals Limited

• United Kingdom
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Medical Information Assistant (maternity cover)

  • Jun 2015 - Nov 2015

  Responding to first and second line medical inquiries, gap analysis for CCDS updates,performing literature searches upon internal and external requests; updating and creation of FAQs and formulary packs; literature screening for PV purposes on weekly basis;participating in monthly Signal Detection Meeting; reviewing clinical papers, standard texts, guidelines and any other relevant for MI, regulatory and commercial activities Responding to first and second line medical inquiries, gap analysis for CCDS updates,performing literature searches upon internal and external requests; updating and creation of FAQs and formulary packs; literature screening for PV purposes on weekly basis;participating in monthly Signal Detection Meeting; reviewing clinical papers, standard texts, guidelines and any other relevant for MI, regulatory and commercial activities



MSD

• Software Development

• Safety Data Specialist

  • Mar 2014 - Feb 2015

  Working as a case processor and intake officer in Data Management Center, Pharmacovigilance Department, Warsaw, Poland. Processing spontaneous adverse drug reaction reports of Merck marketed products, assessing and evaluating reported information, proper analysis including appropriate MedDRA coding conventions for adverse drug reactions and entering the information into ARGUS database; responsible for aggregate submission DBL/, PSUR, DSUR, SUSARs: regular monitoring and tracking reports, sending individual/team reminders on daily basis and cooperation with other DMC in this area, communication with HQ in response to request on Case Finalization alerts. Show less



Co-operative Pharmacy

• United Kingdom
• Personal Care Product Manufacturing
• 1 - 100 Employee

• Locum pharmacist

  • Jul 2013 - Feb 2014

  Working as a locum pharmacist at community pharmacies (including independent pharmacies) in the UK; drug dispensing, clinical checking, delivering NHS core services for patients including: MURs, NMSs, EHC under PGD, opioid substitution for substance misusers services and repeat dispensing, patients' counselling Working as a locum pharmacist at community pharmacies (including independent pharmacies) in the UK; drug dispensing, clinical checking, delivering NHS core services for patients including: MURs, NMSs, EHC under PGD, opioid substitution for substance misusers services and repeat dispensing, patients' counselling



Medical University of Silesia, Poland

• Scientific worker

  • Oct 2008 - Feb 2013

  Conducting lectures on physiology and pathology of cardiovascular system for Pharmacy, Biotechnology, Medical Analytics students. Conducting medical research at District Hospital in Jaworzno, Poland: preparing documents for Ethics Committee approval (informed written consent forms, patients questionnaires), establishing study protocol, patients’ recruitment and interviewing; medical data collection and managing, statistical analysis and results interpretation; preparing professional articles for publishing in medical journals Show less



Polish Community Pharmacies, Silesian area, Poland

• Pharmacist

  • May 2008 - Jan 2012

  Working as a qualified pharmacist and manager deputy. Responsibilities: patients’ counselling, drugs dispensing, preparing compound drugs according to doctors’ prescriptions, accuracy and clinical checking, endorsement checking, stock ordering, maintaining good relations with GPs and medical staff as well as sales representatives Working as a qualified pharmacist and manager deputy. Responsibilities: patients’ counselling, drugs dispensing, preparing compound drugs according to doctors’ prescriptions, accuracy and clinical checking, endorsement checking, stock ordering, maintaining good relations with GPs and medical staff as well as sales representatives