Profil #48040

Having graduated as a biochemist in 1994, I soon specialized in drug safety and development. After fifteen years in the pharmaceutical industry and the Danish Medicines Agency, I took up a new position as Quality Manager at European Sperm Bank and thus changed my focus of interest to tissues and cells. At present, I also manage the position as DPO.

fertilitet sædbank kvalitet GDPR fertility sperm bank quality safety persondata personal data clinic klinik responsible person ansvarlig person  

Opdateret 28. juli 2020
Min uddannelse
- nu

Cand.scient. i Biokemi

Københavns Universitet

Uddannelsesområde: Naturvidenskab
Periode: - nu
Min erhvervserfaring
2018 - nu

Data Protection Officer

European Sperm Bank

As the DPO (Danish Data Protection Act, section 7/GDPR, section 4), my primary job is to ensure that personal data on staff, customers, donors or any other data subjects – are managed in accordance with applicable data protection rules, i.e. the General Data Protection Regulation (GDPR) and national Data Protection Acts.

I hold a number of certificates related to data protection law (e.g. GDPR Master Class) and have worked closely with data protection specialists in law firms such as Bech-Bruun, Accura and Plesner – and not least the Danish Data Protection Agency.

Key responsibilities involve:

• Providing advice and consultation on the GDPR, national Data Protection Acts (DK, UK, DE) and special law (marketing, bookkeeping, cookies etc.).
• Training staff involved in data processing.
• Conducting audits to ensure compliance and address potential issues proactively.
• Serving as the point of contact between the company and Data Protection Agencies (DK, UK, DE) .
• Monitoring performance and providing advice on the impact of data protection efforts.
• Maintaining comprehensive records of all data processing activities conducted by the company.
• Interfacing with data subjects to inform them about how their data is being used, their right and what measures the company has put in place to protect their personal information.
Arbejdsområde: Medicinal & Sundhed
Periode: maj 2018 - nu
2012 - nu

Quality Manager

European Sperm Bank

As Quality Manager, I am responsible for ensuring that company products and services meet the necessary set of standards based on regulatory requirements and customer expectations. This also include complying with the General Data Protection Regulation (GDPR).

Key responsibilities involve:

• Preparing and maintaining of a quality management system.
• Preparing of company quality documents (Quality Manual, policies, SOPs, Work Instructions, templates etc.).
• Training staff.
• Planning, executing and reporting of internal audits.
• Monitoring national, EU and international legislation and ensuring compliance with regulatory requirements.
• Preparing and managing third-party agreements (partners, test labs, service providers, etc.).
• Preparing, hosting and follow up on inspections, external audits and other assessments.
• Liaising with competent authorities in DK, UK and DE (applications, permits, reports, hearings etc.).
• Coordinating with specialists and staff to enhance procedures, operations and regulatory compliance.
• Preparing and managing staff records.
• Assessing of unintended incidents, deviations and complaints.
• Expedited reporting of adverse reactions/unintended incidents.
• Consulting and supporting company units.
• Continuous product development (e.g. exclusive- and known donor, gamete/embryo storage, home insemination, genetic counselling/matching and services related to donor-donor child contact).

In addition – related to the GDPR:

• Preparing, implementing and maintaining a full GDPR-package.
• Training staff in IT security and the management of personal data.
• Preparing of Record of Processing Activities, Data Protection Impact Assessment (DPIA), retention policies and other quality documentation (e.g. policies, standard procedures, contract/consent forms).
• Preparing of Data Processing Agreements, Data Transfer Agreements (EU model clauses) etc.
• Managing data subject requests, personal data breaches etc.
• Preparing, hosting and follow up on audits (internal/external – e.g. data processors), inspections and other assessments.
• Liaising and sparring with Data Protection Agencies (DK, UK, DE), e.g. related to registrations/applications.
• Monitoring national, EU and international legislation/guidelines and ensuring compliance with regulatory requirements.
Arbejdsområde: Medicinal & Sundhed
Periode: december 2012 - nu
2015 - 2020

Responsible Person

European Sperm Bank

As the RP, I had the ultimate responsibility to ensure, that all licensed activities were conducted with proper regard for the regulatory framework, governing treatment and research involving gametes/embryos (i.e. to ensure patients receive the highest quality of treatment).

Key responsibilities involved:

• Ensuring that staff were qualified and had the necessary training and experience to perform their role.
• Ensuring clear responsibilities, roles and systems of accountability to support good governance.
• Ensuring that activities were carried out on suitable premises and that the company used proper equipment.
• Ensuring that proper arrangements were made for the keeping and disposal of gametes/embryos.
• Ensuring that suitable practices were used in the course of the company’s activities.
• Ensuring that conditions of the license were complied with.
• Ensuring that conditions of third-party agreements relating to the procurement, testing, processing or distribution of gametes/embryos were complied with.
• Ensuring that appropriate actions were taken following feedback from the Danish Patient Safety Authority (DPSA), staff and patients. This included taking action on outcomes of inspections, audits, incident investigations, patient complaints and feedback.
• Ensuring that data about certain specified activities and register data were reported to the DPSA accurately and in a timely manner.
• Ensuring that paperwork, fees and data were submitted to the DPSA in a timely manner.
• Ensuring that the company’s staff co-operated fully with inspections and investigations by the DPSA.
• Ensuring that requests for information and/or documents from the DPSA were responded to promptly.
• Ensuring that areas for improvement were identified and changes were successfully implemented (to deliver improvements).
Arbejdsområde: Medicinal & Sundhed
Periode: januar 2015 - april 2020
2012 - 2012

QPPV Associate

ALK-Abello

Recruited as a consultant to cooperate with the Qualified Person for Pharmacovigilance (QPPV) to ensure and monitor drug safety.

Key responsibilities involved:

• Preparing of GAP-analysis, risk assessment and resource estimation to implement new PV legislation.
• Preparing of PV System Master File.
• Ensuring that local business alliance and third parties PV-agreements are in place, up to date and followed as required.
• Ensuring conduct of pharmacovigilance and submission of all pharmacovigilance-related documents in accordance with the legal requirements and Good Vigilance Practice.
• Overseeing the safety profiles of marketed drugs and any emerging safety concerns.
• Input to the EURD-list.
Arbejdsområde: Medicinal & Sundhed
Periode: januar 2012 - oktober 2012
2010 - 2011

Pharmacovigilance Officer

Danish Medicines Agency

As a Pharmacovigilance Officer, I was responsible for monitoring and reporting the effectiveness and side effects of marketed drugs in the general population.

Key responsibilities involved:

• Drug safety surveillance (especially ATC codes A08-A16, D10, G02-D04).
• Assessing of PSURs/RMPs, ADRs, drug interactions, scientific literature etc. and flagging up early warning signs.
• Addressing requests from consumers, HCPs, MAHs, NCAs, the Ministry of Health and the EMA
• Managing of Safety Alerts, Dear Doctor Letters etc.
• Preparing of quality documentation (SOPs, instructions etc.).
• Preparing of newsletters, PV updates, homepage updates etc.
• Training of staff.
Arbejdsområde: Medicinal & Sundhed
Periode: januar 2010 - december 2011
2009 - 2009

Safaty Data Associate

LEO Pharma A/S

As part of Global Patient Safety, I was responsible for surveilling the safety of pharmaceutical products.

Key responsibilities involved:

• Registrating, assessing, unblinding, reporting etc. of ICSRs (EV Gateway).
• Maintaining of drug safety database (ARISg).
• Acting as point of contact for safety queries and support affiliate personnel.
• Communicating with healthcare professionals, business partners etc.
• User Acceptance Testing (E2B Gateway) etc.
• Training of staff.
Arbejdsområde: Medicinal & Sundhed
Periode: januar 2009 - december 2009
2001 - 2008

Safaty Officer

Medicon A/S

As a contract research organization (CRO), Medicon A/S provided support to the pharmaceutical industry in the form of research activities etc. - outsourced on a contract basis. During my time as Safety Officer, I was overall responsible for pharmacovigilance of drugs tested in clinical trials (phase I-III) and played a key role in the success of the company.

Key responsibilities involved:

• Registrating, assessing, coding, unblinding and reporting of SAEs from clinical trials (EV Web).
• Preparing of narratives, query-forms, CIOMS-reports, Annual Safety Reports etc.
• Safety surveillance/signal detection.
• Maintaining telephone helpline (counseling/guidance on drug effects & safety).
• Communicating with clinical research associates, investigators and other healthcare professionals, sponsors, committees (e.g. DMC and Critical Event Committee) and competent authorities.
• Training of investigators, study nurses etc.
• Medical writing (ICTR, protocol etc.).
• Preparing of quality documentation (SOPs, instructions etc.).
• Preparing of PV-agreements and other sponsor-related documentation.
• Translating of medical information (patient journals, epicrises, medical examinations etc.).
• Participating in trial designing.
• Searching for and assessing scientific literature (sponsor products).
• Monitoring national, EU and international legislation and ensuring compliance with regulatory requirements.
• Acting as external consultant.
Arbejdsområde: Medicinal & Sundhed
Periode: januar 2001 - december 2008
2006 - 2007

Consultant

Eli Lilly A/S

Acting as a consultant from Medicon A/S, I assisted in executing various affiliate-related pharmacovigi-lance activities in close collaboration with Global Patient Safety.

Key responsibilities involved:

• Registrating, assessing, unblinding, reporting etc. of ICSRs (EV Gateway).
• Maintaining of drug safety database (Oracle ARGUS).
• Managing of drug safety mailbox
• Acting as point of contact for safety queries and support affiliate personnel.
• Communicating with Global Patient Safety, consumers, business partners etc.
Arbejdsområde: Medicinal & Sundhed
Periode: februar 2006 - december 2007
2005 - 2005

Consultant

H. Lundbeck A/S

Acting as a consultant from Medicon A/S, I assisted in the safety evaluation and surveillance of pharma-ceutical products – marketed and in clinical development.

Key responsibilities involved:

• Registrating, assessing, unblinding, reporting etc. of ICSRs (EV Gateway)
• Maintaining of drug safety database (ARISg)
• Acting as point of contact for affiliate safety queries and support affiliate personnel.
• Communicating with health care professionals, business partners etc.
Arbejdsområde: Medicinal & Sundhed
Periode: februar 2005 - december 2005
1998 - 2000

Safety Assistant

Novartis

Providing support to the safety manager, clinical study team and other line functions in managing and monitoring the safety of pharmaceutical drugs.

Key responsibilities involved:

• Monitoring the safety profile of pharmaceutical drugs.
• Registrating, assessing, unblinding, reporting etc. of ICSRs.
• Providing responses to inquiries from regulatory authorities, healthcare professionals and consumers.
• Interfacing with the clinical team and coordinating with other line functions for associated activities such as updates, analysis of datasets and ongoing tracking of commitments and effectiveness measures.
• Assisting in the preparation of safety documents (e.g. Annual Safety Update Report, Investigator’s Brochure, safety instructions).
• Providing support for licensing activities, inspections, audits and project recall activities.
• Assisting with project activities on an ad hoc basis.
• Monitoring national, EU and international legislation and ensuring compliance with regulatory requirements.
Arbejdsområde: Medicinal & Sundhed
Periode: januar 1998 - december 2000
1997 - 1997

Clinical Research Associate

Novartis

I helped to prepare, coordinate and oversee the execution of clinical trials of pharmaceutical drugs.

Key responsibilities involved:

• Preparing trial-related documentation (protocol amendments, patient information etc.)
• Managing case record- and query forms, batch journals, certificates of analysis, study medication logistics etc.
• Coordinating the collection, distribution and storage of data obtained during clinical trials.
• Participating in review of clinical study protocols reports.
• Communicating with Novartis Healthcare HQ, contract research organizations, investigators and other healthcare professionals.
Arbejdsområde: Medicinal & Sundhed
Periode: januar 1997 - december 1997
1996 - 1996

Regulatory Affairs Assistant

Novartis

Maintenance of processes to ensure that company products were safe and legal, met customer expectations and complied with regulatory requirements.

Key responsibilities involved:

• Preparing document packages for regulatory submissions (e.g. license renewals, annual registrations and variation applications) to ensure compliance with regulatory requirements.
• Maintaining and updating information about global regulatory requirements.
• Responding to customers and/or authorities requests/inquiries dealing with regulations and product compliance.
• Maintaining of product database.
• Reviewing of product labelling and marketing materials for regulatory compliance.
• Translating of product documentation such as Summery of Product Characteristics, Package Insert Leaflets etc.
Arbejdsområde: Medicinal & Sundhed
Periode: januar 1996 - december 1996
Mine kompetencer
Evner
adverse reaction afvigelse alvorlig hændelse ansvarlig person assisted reproduction assisteret reproduktion audit celle complaint data processing agreement data protection officer databehandler databehandleraftale databeskyttelseslov databeskyttelsesloven databeskyttelsesrådgiver deviation donation dpo egg bank fertilitet fertilitetsbehandling fertilitetsklinik fertility clinic fortegnelse over behandlingsaktiviteter gameter gametes gdpr inspection inspektion. klage konsekvensanalyse kunstig befrugtning kvalitet kvalitetsansvarlig kvalitetsdokument kvalitetssystem personal data persondata persondataforordningen persondatasikkerhed quality quality management system quality manager responsible person risikovurdering risk assessment safety samtykke screening sikkerhed sikkerhedsbrist sperm bank sperm donor sædbank sæddonor tilsyn tissue unintended incident utilsigtet hændelse væv vævsbekendtgørelse vævscenter vævscentertilladelse vævsloven ægbank ægdonor
Sprog på arbejdsniveau
dansk engelsk
Mine præferencer
Jobtype
Deltidsjob Freelance Fuldtidsjob
Arbejdsområde
Forskning & Udvikling Medicinal & Sundhed Naturvidenskab Rådgivning & Support Socialvæsen
Geografi
Bornholm Fyn Midtjylland Nordjylland Nordsjælland Storkøbenhavn Sydvestjylland (Esbjerg) Sydøstjylland Sønderjylland Vestjylland Vestsjælland Øresundsregionen Østjylland (Aarhus) Østsjælland
Kontakt mig!