Over Diego
Key expertise:
• Signal detection & management (FDA/EMA/VAERS/EudraVigilance)
• ICSR case processing, PSUR/PBRER/RMP authoring & review
• GVP audits, CAPA, pharmacovigilance compliance
• Safety in vaccines, oncology, immuno-inflammatory diseases
• Pharmacovigilance support (case processing, signal assessment)
• PSUR/RMP writing & review
• GVP audits and inspection preparation
• Safety consulting for biotech/pharma
• Local Contact Person for PV (LCPPV)
Skills
Pharmacovigilance, Drug Safety, Signal Detection, Signal Management, ICSR, PSUR, PBRER, RMP, GVP, Pharma Compliance, Medical Affairs, Regulatory Affairs, Vaccines, Oncology, Immunology, Case Processing, GVP Audits, Risk Management, FDA, EMA, EudraVigilance, VAERS.
Now available as a freelance consultant for short- or long-term missions (remote):
Immediately available – flexible (part-time or full-time)
Feel free to reach out to discuss your needs. Quick response guaranteed.
Please visit my Linkedin profile to get the full idea on my career.
Frans
Tweetalig / moedertaal
Engels
Tweetalig / moedertaal
Uitsluitend remote
Werkt voornamelijk remote
Werkervaring
- GSKAssociate Medical Director, Safety Evaluation & Risk ManagementPHARMACEUTISCHE INDUSTRIEjuli 2022 - maart 2026 (3 jaren en 8 maanden)Wavre, BW, Belgium• Led global pharmacovigilance and safety signal management strategies for assigned products.• Performed benefit-risk assessments and aggregate safety data reviews, ensuring compliance with regulatory requirements.• Drove cross-functional collaboration with Regulatory Affairs, Clinical Development, and Medical Affairs to align safety communications and strategies.• Prepared and review safety sections of clinical and regulatory documents, including study protocols, IBs, CSRs, and ICFs.• Led periodic safety report preparation (PSURs, DSURs) and safety submissions for global regulatory agencies.• Provided safety leadership for Data Safety Monitoring Boards (DSMBs) and internal safety governance.• Oversaw medical assessments of individual case safety reports (ICSRs) and ensure timely reporting of SUSARs and urgent safety issues.
- GSKSenior Manager Safety Physician, Safety Evaluation & Risk ManagementPHARMACEUTISCHE INDUSTRIEnovember 2018 - juni 2022 (3 jaren en 7 maanden)Wavre, BW, Belgium• • Chaired Safety Review Team (SRT) meetings, leading discussions on benefit-risk evaluations.• • Authored and reviewed key safety documents, including PSURs, DSURs, RMPs, and regulatory responses.• • Provided medical oversight for safety sections in clinical trial documentation (protocols, CSRs, IBs, and ICFs).• • Led safety discussions with regulatory agencies and participated in IDMC/DSMB meetings.
- GSKVaccines Medical Affairs ManagerPHARMACEUTISCHE INDUSTRIEdecember 2015 - februari 2018 (2 jaren en 2 maanden)Kinshasa, KN, Democratic Republic of Congo• Provided medical and scientific leadership in vaccine safety and risk management.• Engaged with Key Opinion Leaders (KOLs) and healthcare professionals to support vaccine education and advocacy.• Managed regional pharmacovigilance strategies, strengthening regulatory compliance in Central Africa.
Aanbevelingen
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Opleidingen
- Executive MasterUniversity of Siena & Novartis Vaccines Academy2014Executive Master
- Doctor of Medicine (MD)University of Kinshasa2010Doctor of Medicine (MD)