Nordic Pharmacovigilance Day

Wasim Anwar is a medical graduate from King Edward Medical University, Pakistan and holds a PgD in Pharmacovigilance from University of Hertfordshire, UK. He has over 10 years of experience in the field of pharmacovigilance (PV) while working in different biopharmaceuticals companies in various capacities both as a PV professional as well as a leader. Currently he is working at Global Safety, Novo Nordisk A/S as Deputy QPPV and heading up the team of pharmacovigilance experts responsible for supporting and maintaining global oversight and compliance to pharmacovigilance regulations and processes.

Dr. Caroline Sandström received her PhD in Medical Science from Lund University, Sweden in 2008. Her special interest for chronic inflammation, pharmacology and immunology was reflected in the thesis which was dealing with both human and murine-based systems. She has then worked for Novo Nordisk A/S, Denmark for several years as a pharmacologist driving and executing pharmacological plans supporting pre-clinical projects. Her interest and enthusiasm for project management, continuous improvement, streamlining initiatives and training was then later beneficially used when she moved into the compliance area managing global improvement and training initiatives within R&D Quality Management System (QMS) including Clinical. She was the project manager for implementing the effective use of Root Cause Analysis in Clinical Development activities but also being highly involved in initiatives related to Quality Culture. After almost seven years in Novo Nordisk A/S, Caroline Sandström started as Compliance Specialist at Ferring Pharmaceuticals A/S in Copenhagen, DK. On a daily basis she has been involved in discussing, driving compliance and improvement initiatives within both Non-Clinical, Clinical and Pharmacovigilance related activities. She has taken a very active role in contributing to a collaborative and transparent organization where sharing learnings are a main focus area. From beginning of May 2022 she moved into the position of being Head of the Global Clinical Quality Department. Her scientifically driven problem solving skills are used for implementing global cross-functional initiatives, supporting and strengthening the harmonization and quality mindset in the organization.

Mette has an MSc in Pharmacy from the then Royal Danish School of Pharmacy and a MSc in Pharmacovigilance from the University of Hertfordshire, UK. She has profound knowledge of global pharmacovigilance legislation, compliance, impact assessments, pharmacovigilance processes and systems stemming from more than 20 years pharmacovigilance experience from Ferring, Novo Nordisk and LEO Pharma. In her previous positions she has been responsible for case processing for post-marketing and clinical trials, coordinating and providing PV input audits and inspections PV, GCP and GMP areas, for PV intelligence and impact assessments of new legislation, QPPV review and approval of PSURs, ACOs and RMPs, responses to regulatory requests and compliance with GDPR across safety processes. In her current role she Head of Pharmacovigilance, QPPV, at Hansa Biopharma AB

Klaus Bitsch-Jensen has a master degree in pharmaceutical science from the Danish Pharmaceutical University, Copenhagen, and a graduate diploma in business administration from Copenhagen Business School.
He has worked within the pharmaceutical industry since 2007 primarily within pharmacovigilance, within different pharmaceuticals companies, and in various roles within safety operations, safety surveillance, and QPPV Office settings.
He is currently working at ALK as Director, Head of QPPV Office & EU/UK-QPPV heading up a team of pharmacovigilance specialists responsible for the maintenance of the EU-PSMF & national PSMF management, regulatory surveillance, performance monitoring, PV training, PV Agreements, and general support to affiliates and partners.

Michael has been working in medicinal product safety for the last three decades. He spent 13 years at the European PV headquarters of Fujisawa, which later became Astellas, ultimately leading the Safety Data and Quality Management group. Thereafter he joined Relsys, the developer of the Argus software, and finally came to Oracle with the Relsys acquisition in 2009. As a senior director in the safety strategy team, he helps drive the product roadmap of the Oracle Safety One Platform including Argus, Empirica, Safety One Intake, and Oracle Analytics.

Pilar Carrero is a Medical Doctor with a PhD in Biochemistry & Molecular Biology with 20+ years of experience in the pharmaceutical industry. She has dedicated 15 years to research in both academia (Karolinska Institute in Stockholm) and industry (Novo Nordisk in Copenhagen) working in metabolic diseases and oncology, and 18 years in different roles in pharmacovigilance where she has been a frontrunner in the implementation of optimization activities in processes and systems. Pilar is heading up Global Safety at LEO Pharma since October 2021 where the area has embarked in the implementation of a new safety platform. Pilar is passionate about new technologies and their application to transform the way we work.

Gitte Eiersholt is a pharmaconomist, trained at a Danish pharmacy and has worked within the pharmaceutical industry after the education. In addition, Gitte holds a master degree in data linguistics and training certificates in coaching, managing diversity, and successful cooperation.
She has worked with PSMF management since 2013, first with Novo Nordisk and since 2020 with ALK.
She is currently working at ALK as a senior PV specialist focusing on how to manage local PSMF requirements in the most efficient and standardized way to the benefit of the MAH and the partner facing the requirement.

Masters’ in Pharmacy at Copenhagen University. Currently working as Senior Manager in Quality Audits, Novo Nordisk A/S heading up the department “Pharmacovigilance and GDP Audits”. He is responsible for the operational management of team of auditors responsible for GDP/PV oversight within the organization.

Has more than 25 years of auditing and quality experience in pharmaceutical industry which includes auditing in all GxP areas globally, in depth knowledge pharmaceutical processes/ analyses, quality tools and philosophies. Has acquired understanding on Validation, IT and digital innovation and its impact on Pharmacovigilance system within the organization and HA requirements. Involved in implementing successful internal audit programs that have contributed to the company’s growth and success. Is responsible for managing and leading the PV and GDP auditors which contributed to enhancing the company’s internal controls, risk management, and compliance frameworks.

Has been an active mentor to several internal audit professionals within Novo Nordisk, and has provided them with valuable guidance, support, and professional development opportunities.

I am a Swedish pharmacist with strong interests in patient safety and pharmacovigilance. I began my career within Pharmacovigilance in 2006 when I joined the Uppsala Monitoring Centre (UMC), a WHO Collaborating Centre for International Drug Monitoring. At the UMC my main responsibilities included signal management (detection and assessment of risks associated with the use of a medicinal product) as well as education and pharmacovigilance training of staff at national pharmacovigilance centres.
Since 2014, I have held several positions within the pharma industry, mainly in the areas of setting up pharmacovigilance systems, ICSR handling, risk management, pharmacovigilance auditing, signal management and pharmacovigilance training.
In my current role as a Pharmacovigilance Inspector, I plan and conduct national pharmacovigilance inspections, participate in international working groups and carrying out inspections on behalf of EMA.

Associate Director, Deputy QPPV, PV Operations (MSc.Pharm., certified internal auditor ISO 13485, certified process consultant) with more than 13 years of experience in different roles working with medicinal products, medical devices and combination products across all stages from early development throughout products’ lifecycle.

Currently and for the last six years, course responsible/instructor for the annual 1.5 days course on planning an effective post-market surveillance (PMS) program for medical devices and combination products at Medicoindustrien.

Currently and for the last six years, chairwoman for the Medtech industry’s large PMS group at Medicoindustrien.

Søren Nilaus Præstegaard is a pharmacist by training and has been working in the pharmaceutical industry since 2004. Since 2007, Søren has been working within the pharmacovigilance area in companies such as Ferring Pharmaceuticals, NeuroSearch, LEO Pharma A/S and Novo Nordisk A/S. Through his career, Søren has been working within many different areas within Pharmacovigilance in both specialist and management positions and has obtained broad knowledge of the different aspects of Pharmacovigilance. In Søren’s current role as a PV Compliance Specialist in Novo Nordisk, he is responsible for Pharmacovigilance intelligence.

Shannen is a communicator by trade and a creative at heart. She enjoys crafting compelling social media campaigns using several mediums, whether that be graphic design, film, data visualisations, copywriting or more. She is passionate about telling unique stories and turning complex ideas or methodologies into digestible and engaging content. Before joining Uppsala Monitoring Centre (UMC) in 2022, she worked with various communications tasks at the Stockholm International Peace Research Institute (SIPRI). She holds a BA from Simon Fraser University (Canada) and an MA from Uppsala University (Sweden).