Post-market safety surveillance, Signal detection & evaluation, Benefit-risk & product risk assessment, ICSR review, Aggregate reports, RMP.
Aktualisiert am 14.09.2026
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 01.10.2026
Verfügbar zu: 100%
davon vor Ort: 100%
Good Pharmacovigilance Practice
Good Clinical Practice
Medical writing
Medical review
case processing
Meddra coding
Aggregate report writing
Submission for FDA
EMA submission
PMDA submission
C
NMPA Submission
ICH guidelines
PRAC response Document
Health authority response documents
Risk management plans
PSUR
DSUR
ACO
PBRER
Lind listings
Signal detection report
English
ILR 4
Hindi
ILR 4
Kannada
ILR 4
German
ILR 1

Einsatzorte

Einsatzorte

Frankfurt am Main (+500km) United kingdom (+200km)
Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

1 year 5 months
2025-05 - now

Development, review, and maintenance of standard operating procedures

Genetic Consultant
Genetic Consultant
  • Develop, review and maintain SOPs, work instructions, policies and procedural documentation.
  • Perform process mapping and identify opportunities for standardisation, compliance and continuous process improvement.
  • Support controlled documentation, version management, audit readiness and quality-focused processes.
  • Collaborate with SMEs and stakeholders to translate complex operational requirements into practical, sustainable processes.
SUMOGENOMICS LTD
Germany
10 months
2024-07 - 2025-04

Preparation of PSURs and DSURs for products in Europe

PV Aggregate Report Scientist/ Clinical Safety Consultant
PV Aggregate Report Scientist/ Clinical Safety Consultant
  • Led project management activities for PSUR and DSUR preparation for marketed specialty medicines in Europe.
  • Coordinated timelines, documentation, contributors and external vendors to ensure timely safety deliverables.
  • Worked with safety physicians on EU-RMP updates, signal detection and assessment, and evaluation of emerging safety signals.
  • Supported safety communication and EU risk-minimisation activities with affiliates and Local Safety Officers.
  • Supported regulatory and labelling considerations arising from safety surveillance.
DAIICHI-SANKYO
Germany
11 months
2023-07 - 2024-05

Support with summary safety reporting

PV Safety Scientist/ Clinical Safety Consultant
PV Safety Scientist/ Clinical Safety Consultant
  • Supported aggregate safety reporting, routine safety surveillance, signal identification/ evaluation and EU-RMP activities.
  • Supported safety communications, regulatory/product-labelling assessments and cross-functional stakeholder coordination.
  • Managed project activities, timelines and safety deliverables.
DAIICHI-SANKYO
Germany
1 year 2 months
2022-05 - 2023-06

Submission of PSURs, DSURs, PADERs, RMPs and CCDSs

Pharmacovigilance Consultant
Pharmacovigilance Consultant
  • Authored and supported submission of PSURs, DSURs, PADERs, RMPs and CCDSs.
  • Prepared and reviewed signal assessments, safety documentation and health-authority materials.
  • Supported QA, CAPA, audit readiness and compliance activities; contributed to training and mentoring.
REGULATORY EXPERTS LTD
UK
3 months
2021-08 - 2021-10

Support for signal assessment reports, RMPs and CCDSs

Benefit-Risk Scientist
Benefit-Risk Scientist
  • Prepared/reviewed PSURs, DSURs, PADERs and ACOs; supported signal assessment reports, RMPs and CCDSs.
  • Contributed to benefit-risk evaluation, safety variations, audit/inspection readiness, deviations and CAPA.
  • Supported submission metrics, scheduling, forecasting and client/stakeholder communication.
DIAMOND PHARMA SERVICES
UK
1 year
2019-06 - 2020-05

Support for security monitoring

PV Project Manager - Oncology
PV Project Manager - Oncology
  • Supported safety surveillance, signal evaluation and clinical safety assessment in oncology.
  • Contributed to DSURs, PSUSARs, Investigator?s Brochures and RMPs and supported PMDA, EMA and FDA-related activities.
  • Worked with regulatory, data management, literature and safety stakeholders; developed dashboards and tracked actions.
  • Gained exposure to medical-device/product safety risk-management activities within broader product safety and risk assessment.
MERCK
Darmstadt (Germany)
7 months
2018-12 - 2019-06

GPS Operations

Associate Consultant
Associate Consultant
Supported ICSR processing, coding, narratives, data quality, QC, medical review and submission readiness.
MERCK
Germany
1 year 2 months
2017-10 - 2018-11

GPS PV LCM

Contract Senior Safety Scientist
Contract Senior Safety Scientist
  • Supported a major product safety crisis involving a significant increase in ICSR reporting.
  • Prioritised medical review/approval, contributed to benefit-risk reporting and safety assessments, and supported health-authority briefing activities.
  • Performed literature review, signal detection and RMP/risk-minimisation activities.
MERCK
Germany
6 months
2017-04 - 2017-09

Support for locking or finalizing the security database

Contract Senior Pharmacovigilance Associate
Contract Senior Pharmacovigilance Associate
  • Supported safety database lock/closure, clinical and safety database reconciliation, safety queries and study-specific safety management plans.
  • Worked across multiple clients and therapeutic areas and supported training.
WORLDWIDE CLINICAL TRIALS
UK
1 year 9 months
2015-07 - 2017-03

Conducting ED triage

Regulatory Affairs Officer & Safety Associate
Regulatory Affairs Officer & Safety Associate
  • Performed AE triage/assessment, database entry, coding, seriousness, narratives, causality and labelling activities.
  • Supported reconciliation across Medical Information, Quality and external partners and reviewed regulatory submission packages.
THE REGULATORY EXPERTS LTD
UK

Aus- und Weiterbildung

Aus- und Weiterbildung

08/2013
MSc Clinical Research Management
Cranfield University, UK

1997 - 2003
BAMS
Rajiv Gandhi University of Health Sciences, Bangalore, India

Position

Position

PHARMACOVIGILANCE & CLINICAL SAFETY PROFESSIONAL

Kompetenzen

Kompetenzen

Top-Skills

Good Pharmacovigilance Practice Good Clinical Practice Medical writing Medical review case processing Meddra coding Aggregate report writing Submission for FDA EMA submission PMDA submission C NMPA Submission ICH guidelines PRAC response Document Health authority response documents Risk management plans PSUR DSUR ACO PBRER Lind listings Signal detection report

Schwerpunkte

  • Pharmacovigilance & Drug Safety Management
  • Safety Surveillance & Signal Management
  • Benefit-Risk Assessment
  • Aggregate Safety Reporting: PSUR/ PBRER/ DSUR/ PADER/ ACO
  • Risk Management Plans & Risk Minimisation
  • Regulatory Safety Compliance
  • Quality Management, Deviations & CAPA
  • SOP & Work Instruction Development
  • Process Mapping & Continuous Improvement
  • Audit & Inspection Readiness
  • Vendor & Stakeholder Management
  • Cross-functional Project Leadership
  • ICSR Processes & Medical Review
  • Literature Surveillance
  • Regulatory Submissions: MAA/ NDA/ CTD
  • Safety Communications & Labelling

Produkte / Standards / Erfahrungen / Methoden

PROFILE
Pharmacovigilance and Clinical Safety professional with 10+ years of experience across pharmaceutical companies, CROs and consulting environments in Germany and the UK. Extensive expertise in pharmacovigilance systems, safety surveillance, signal detection and evaluation, benefit-risk assessment, aggregate reporting, risk management, regulatory compliance, quality processes and inspection readiness. Experienced in leading cross-functional safety activities, developing SOPs and controlled documentation, managing deviations/CAPA-related activities and coordinating internal and external stakeholders. During experience at Merck, gained exposure to medical-device/product safety risk-management activities, providing a foundation for the interface between product safety, risk assessment and pharmacovigilance. Currently focused on SOPs, process mapping, compliance and continuous improvement.

THERAPEUTIC EXPERIENCE
  • Clinical Development: Immunology; Oncology ? Phases I, II and III. Post-Marketing: Neurology; General Medicine; Fertility; Oncology; Immunology; Specialty Medicines.

Einsatzorte

Einsatzorte

Frankfurt am Main (+500km) United kingdom (+200km)
Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

1 year 5 months
2025-05 - now

Development, review, and maintenance of standard operating procedures

Genetic Consultant
Genetic Consultant
  • Develop, review and maintain SOPs, work instructions, policies and procedural documentation.
  • Perform process mapping and identify opportunities for standardisation, compliance and continuous process improvement.
  • Support controlled documentation, version management, audit readiness and quality-focused processes.
  • Collaborate with SMEs and stakeholders to translate complex operational requirements into practical, sustainable processes.
SUMOGENOMICS LTD
Germany
10 months
2024-07 - 2025-04

Preparation of PSURs and DSURs for products in Europe

PV Aggregate Report Scientist/ Clinical Safety Consultant
PV Aggregate Report Scientist/ Clinical Safety Consultant
  • Led project management activities for PSUR and DSUR preparation for marketed specialty medicines in Europe.
  • Coordinated timelines, documentation, contributors and external vendors to ensure timely safety deliverables.
  • Worked with safety physicians on EU-RMP updates, signal detection and assessment, and evaluation of emerging safety signals.
  • Supported safety communication and EU risk-minimisation activities with affiliates and Local Safety Officers.
  • Supported regulatory and labelling considerations arising from safety surveillance.
DAIICHI-SANKYO
Germany
11 months
2023-07 - 2024-05

Support with summary safety reporting

PV Safety Scientist/ Clinical Safety Consultant
PV Safety Scientist/ Clinical Safety Consultant
  • Supported aggregate safety reporting, routine safety surveillance, signal identification/ evaluation and EU-RMP activities.
  • Supported safety communications, regulatory/product-labelling assessments and cross-functional stakeholder coordination.
  • Managed project activities, timelines and safety deliverables.
DAIICHI-SANKYO
Germany
1 year 2 months
2022-05 - 2023-06

Submission of PSURs, DSURs, PADERs, RMPs and CCDSs

Pharmacovigilance Consultant
Pharmacovigilance Consultant
  • Authored and supported submission of PSURs, DSURs, PADERs, RMPs and CCDSs.
  • Prepared and reviewed signal assessments, safety documentation and health-authority materials.
  • Supported QA, CAPA, audit readiness and compliance activities; contributed to training and mentoring.
REGULATORY EXPERTS LTD
UK
3 months
2021-08 - 2021-10

Support for signal assessment reports, RMPs and CCDSs

Benefit-Risk Scientist
Benefit-Risk Scientist
  • Prepared/reviewed PSURs, DSURs, PADERs and ACOs; supported signal assessment reports, RMPs and CCDSs.
  • Contributed to benefit-risk evaluation, safety variations, audit/inspection readiness, deviations and CAPA.
  • Supported submission metrics, scheduling, forecasting and client/stakeholder communication.
DIAMOND PHARMA SERVICES
UK
1 year
2019-06 - 2020-05

Support for security monitoring

PV Project Manager - Oncology
PV Project Manager - Oncology
  • Supported safety surveillance, signal evaluation and clinical safety assessment in oncology.
  • Contributed to DSURs, PSUSARs, Investigator?s Brochures and RMPs and supported PMDA, EMA and FDA-related activities.
  • Worked with regulatory, data management, literature and safety stakeholders; developed dashboards and tracked actions.
  • Gained exposure to medical-device/product safety risk-management activities within broader product safety and risk assessment.
MERCK
Darmstadt (Germany)
7 months
2018-12 - 2019-06

GPS Operations

Associate Consultant
Associate Consultant
Supported ICSR processing, coding, narratives, data quality, QC, medical review and submission readiness.
MERCK
Germany
1 year 2 months
2017-10 - 2018-11

GPS PV LCM

Contract Senior Safety Scientist
Contract Senior Safety Scientist
  • Supported a major product safety crisis involving a significant increase in ICSR reporting.
  • Prioritised medical review/approval, contributed to benefit-risk reporting and safety assessments, and supported health-authority briefing activities.
  • Performed literature review, signal detection and RMP/risk-minimisation activities.
MERCK
Germany
6 months
2017-04 - 2017-09

Support for locking or finalizing the security database

Contract Senior Pharmacovigilance Associate
Contract Senior Pharmacovigilance Associate
  • Supported safety database lock/closure, clinical and safety database reconciliation, safety queries and study-specific safety management plans.
  • Worked across multiple clients and therapeutic areas and supported training.
WORLDWIDE CLINICAL TRIALS
UK
1 year 9 months
2015-07 - 2017-03

Conducting ED triage

Regulatory Affairs Officer & Safety Associate
Regulatory Affairs Officer & Safety Associate
  • Performed AE triage/assessment, database entry, coding, seriousness, narratives, causality and labelling activities.
  • Supported reconciliation across Medical Information, Quality and external partners and reviewed regulatory submission packages.
THE REGULATORY EXPERTS LTD
UK

Aus- und Weiterbildung

Aus- und Weiterbildung

08/2013
MSc Clinical Research Management
Cranfield University, UK

1997 - 2003
BAMS
Rajiv Gandhi University of Health Sciences, Bangalore, India

Position

Position

PHARMACOVIGILANCE & CLINICAL SAFETY PROFESSIONAL

Kompetenzen

Kompetenzen

Top-Skills

Good Pharmacovigilance Practice Good Clinical Practice Medical writing Medical review case processing Meddra coding Aggregate report writing Submission for FDA EMA submission PMDA submission C NMPA Submission ICH guidelines PRAC response Document Health authority response documents Risk management plans PSUR DSUR ACO PBRER Lind listings Signal detection report

Schwerpunkte

  • Pharmacovigilance & Drug Safety Management
  • Safety Surveillance & Signal Management
  • Benefit-Risk Assessment
  • Aggregate Safety Reporting: PSUR/ PBRER/ DSUR/ PADER/ ACO
  • Risk Management Plans & Risk Minimisation
  • Regulatory Safety Compliance
  • Quality Management, Deviations & CAPA
  • SOP & Work Instruction Development
  • Process Mapping & Continuous Improvement
  • Audit & Inspection Readiness
  • Vendor & Stakeholder Management
  • Cross-functional Project Leadership
  • ICSR Processes & Medical Review
  • Literature Surveillance
  • Regulatory Submissions: MAA/ NDA/ CTD
  • Safety Communications & Labelling

Produkte / Standards / Erfahrungen / Methoden

PROFILE
Pharmacovigilance and Clinical Safety professional with 10+ years of experience across pharmaceutical companies, CROs and consulting environments in Germany and the UK. Extensive expertise in pharmacovigilance systems, safety surveillance, signal detection and evaluation, benefit-risk assessment, aggregate reporting, risk management, regulatory compliance, quality processes and inspection readiness. Experienced in leading cross-functional safety activities, developing SOPs and controlled documentation, managing deviations/CAPA-related activities and coordinating internal and external stakeholders. During experience at Merck, gained exposure to medical-device/product safety risk-management activities, providing a foundation for the interface between product safety, risk assessment and pharmacovigilance. Currently focused on SOPs, process mapping, compliance and continuous improvement.

THERAPEUTIC EXPERIENCE
  • Clinical Development: Immunology; Oncology ? Phases I, II and III. Post-Marketing: Neurology; General Medicine; Fertility; Oncology; Immunology; Specialty Medicines.

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