Jeg søger stilling som kemiker, biolog eller forsker i Hele Danmark

Experience

Data Protection Officer (DPO) – since 2018
European Sperm Bank ApS

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.

Responsible Person (RP)* – 2015-2020
Nordic Cryobank ApS/European Sperm Bank ApS
*) Not formally registered as RP with the Danish Patient Safety Authority - but carrying out/responsible for RP tasks.

Carrying out the tasks as RP, I was responsible for ensuring, 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).

Quality Manager – since 2013
Nordic Cryobank ApS/European Sperm Bank ApS

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.

Consultant (LRC Consult) – 2012
Nordic Cryobank ApS

Recruited as a consultant to follow up on an inspection by the Danish Medicines Agency (now the Danish Patient Safety Authority).

Key responsibilities involved:

• Liaising with the DMA/follow up on findings.
• Securing compliance with regulatory requirements.
• Preparing of quality documentation (SOPs, instructions etc.).
• Monitoring national and EU legislation and ensuring compliance with regulatory requirements.

Consultant (LRC Consult)/QPPV Associate – 2012
ALK-Abelló A/S, Dept. of Research & Development

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.

Pharmacovigilance Officer – 2010-2012
Danish Medicines Agency, Consumer Safety Division

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.

Safaty Data Associate – 2009-2010
LEO Pharma, Global Patient Safety/Safety Data Management

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.

Safaty Officer – 2001-2009
Medicin A/S (later Cyncron 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.

Consultant (Medicon A/S) – 2006-2007
Eli Lilly A/S, Dept. of Pharmacovigilance

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.

Consultant (Medicon A/S) – 2005
Lundbeck A/S, International Safety & Pharmacovigilance

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.

Safety Assistant – 1998-2001
Novartis Healthcare A/S, Clinical Safety & Epidemiology

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.

Clinical Research Associate – 1997
Novartis Healthcare A/S, Clinical Research

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.

Regulatory Affairs Assistant – 1996-1997
Novartis Healthcare A/S, Drug Regulatory Affairs

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.

Education

Master of Science (cand. scient.): Biochemistry - 1994
University of Copenhagen, Denmark

Post-graduate Education

Key certificates:

• GDPR Master Class – 2019-2020
Plesner, Copenhagen
• Data Protection Law Certificate - 2018
Plesner, Copenhagen
• Internal Auditing – 2015
Danish Technological Institute, Taastrup
• Medical Genetics – 2013
University of Copenhagen
• Document Management – 2013
Pharmakon (Danish College of Pharmacy Practice), Hillerød
• Pharmacoepidemiology (Medicademy Pharmacovigilance, module 3) – 2011
The Danish Association of the Pharmaceutical Industry (Lif), Copenhagen
• Pharmacovigilance - Post Marketing – 2010
Pharmakon (Danish College of Pharmacy Practice), Hillerød
• Good Clinical Practice (GCP) – 2006
Medicon A/S, Allerød
• Clinical Drug Development – 2005
The Danish Association of the Pharmaceutical Industry (Lif), Copenhagen
• EudraVigilance User Training Course – 2005
Pharmakon (Danish College of Pharmacy Practice), Hillerød
• Safety and Pharmacovigilance (module 2) – 2001
The Danish Association of the Pharmaceutical Industry (Lif), Copenhagen
• Pharma Consultant Program – 2003-2004
The Danish Association of the Pharmaceutical Industry (Lif), Copenhagen
• Safety and Pharmacovigilance (module 1) – 2001
The Danish Association of the Pharmaceutical Industry (Lif), Copenhagen

Additional Information
For additional information – e.g. recommendations/statements and personal type assessment - please see my LinkedIn profile: https://dk.linkedin.com/in/lars-rolighed-11367759. Relevant diplomas, personal profile assessments and contact information on reference persons may be forwarded upon request.