Rainer Kpeglo
Insulet
Shefford,England
1
Language
7
Years of experience
Pharmacovigilance, medical information and quality professional with over 10 years’ experience across drug safety, post-market surveillance, regulatory reporting and clinical practice. Physician Associate with strong clinical knowledge and experience reviewing scientific literature, clinical data and regulatory documentation, providing evidence-based medical information, identifying safety signals and supporting risk management activities. Experienced in working collaboratively with cross-functional teams and translating complex medical and scientific information for different stakeholders. Now seeking to transition into Medical Affairs, bringing a strong combination of clinical expertise, pharmacovigilance knowledge, medical information experience and regulatory understanding to support evidence-based product and patient-focused activities.
Work History
Senior Global Product Surveillance Specialist
9 Months- Led post-market surveillance activities to ensure ongoing product safety, compliance, and performance in accordance with ISO 13485, MDR, FDA 21 CFR Part 820, and internal quality systems.
- Performed critical care trend analysis (CCT) with integrated medical reviews to identify trends, optimize patient management and support clinical governance.
- Conducted systematic review, assessment, and investigation of customer complaints, adverse events, and product performance issues across multiple product lines.
- Prepared regulatory reports, including vigilance submissions, MDR, MIR, MDIR, KSA reports and trend analyses for internal and external stakeholders.
- Developed and updated surveillance documentation, procedures, and work instructions to maintain compliance and improve operational efficiency.
Product Surveillance Reporting Specialist
6 Months- Lead decision-maker for medical devices reportability decisions and vigilance reporting including local and global submissions, collaborating with cross functional teams for submissions and escalations to the ministry of health and regulatory authorities in EAME and USA. Manage the timeline for end-to-end reporting.
- Writing aggregate reports, oversee regular reporting needs and external requests to maintain safety surveillance standards. Initiate corrective and preventive measures, ensure adherence to industry regulations, safety standards and customer requirements. Perform post-market quality assurance standards and improving processes. Contributed to internal audit readiness and compliance tasks.
- (Contract)
Physician Associate
6 Years 1 Month- Took history, examined, diagnosed and offered clinical/ pharmacological management to patients with acute/ chronic illness.
- Led quality improvements such as Quality Outcome Framework, audits, and prevalence work to enhance patient care quality at NHS.
- Led clinical team in managing diabetes, COPD, Asthma Hypertension, neurological and oncology conditions and improving patient care outcomes.
- Performed oncology reviews as part of quality outcome framework and supported clinical governance activities.
- Conducted complaints review and patient safety investigations to ensure high standards of care.
- Reviewed patient records to ensure compliance with clinical guidelines.
- Maintained comprehensive patient charts to facilitate continuum of care and document patient assessments, interventions and results.
- Ordered blood tests and samples for testing and communicated outcomes to progress patient cases.
- Triaged patients to establish priority cases and respond accordingly.
- Provided follow-up calls to establish patients' response to medication and treatment plans for good care continuity.
- Acted with discretion and compassion to maintain patient dignity and comfort during sensitive consultations.
- Educated patients on diagnoses, treatments and medications and self-management to drive recovery and outcome goals.
- Put together targeted treatment protocols and medication regimens to alleviate patient symptoms.
- Reviewed patient medical information and completed thorough physical examinations, discussing current symptoms and concerns to gain complete picture of present health and wellness.
- Advised patients of medication options and support decision-making according to personal preferences.
Lead Pharmacovigilance Specialist
4 Months- Short term contract where I oversaw the smooth running of the UK/IE case management team in neurology and oncology therapeutic areas, ensuring compliance with local/EU legal requirements.
- I identified signal trends using qualitative and quantitative methods, updated drug labels, performed risk minimization measures and managements. Performed ongoing surveillance through post market studies and periodic safety reports.
- Reviewed and processed development safety update report (DSUR) submission for UK/IE.
- Acted as the UK/IE case management SME in audits and inspections.
- Updated local addendums, gap assessments and wrote departmental standard operating procedures (SOP).
- (contract)
Senior PV/ Medical Information Specialist
3 Years 5 Months- Provided periodic safety summaries including PBRER, DSUR to project stakeholders. Prepared clinical safety summaries such as safety management plans. I identified signal issues and performed risk management activities to ensure product safety. Streamlined operations, timelines and audit readiness for regulatory compliance. Provided accurate and evidence-based medical information to healthcare professionals, patients and internal stakeholders in response to product or therapeutic area-related inquiry. Reviewed, interpreted and analyzed scientific literature, clinical trial data and regulatory documents to ensure accurate information is provided.
Education
PgDip - Physician Associate Studies
BSc (Hons) - Biomedical Science
Skills
Accurate data entry
Analytical
Argus
Audits
Clinical Research
Clinical trials
Coaching
Collaboration
Coordinating
Database Management
Emergency response
Healthcare services.
MedDRA
Operational excellence
Patient Care
PSUR
Quality control
Regulatory Compliance
Regulatory reporting
Risk management
Safety management
Signal detection
Standard Operating Procedures
Strategic leadership
Study protocols.
Vigilance reporting
Post-market surveillance
Aggregate reporting
Excel analysis
Regulatory compliance
Quality systems
Audit readiness
Process improvement
Information analysis
Stakeholder communication
Cross functional collaboration
Problem solving
Excel proficiency
Database management
Languages
English
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
Senior Global Product Surveillance Specialist
Insulet
08.2025 - 05.2026Read More
Product Surveillance Reporting Specialist
Abbvie
03.2025 - 09.2025Read More
Lead Pharmacovigilance Specialist
Teva Pharmaceuticals
07.2024 - 11.2024Read More
Senior PV/ Medical Information Specialist
Peterson Pharma
01.2021 - 06.2024Read More
Physician Associate
NHS England
01.2019 - 02.2025Read More
St Georges Medical School, University of London
PgDip from Physician Associate Studies
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Nottingham Trent University
BSc (Hons) from Biomedical Science
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