Hela Lakhoua
Renens
Summary
PharmD-qualified Pharmacovigilance Specialist with a solid background in pharmacovigilance project management and regulatory reporting. I have experience working at both Bristol-Myers Squibb (BMS) as a PSMF Manager and at Servier as a Pharmacovigilance Project Manager. I am now seeking to leverage my expertise in a project management role within a forward-thinking pharmaceutical company, where I can drive impactful projects and contribute to patient safety.
Overview
7
7
years of professional experience
Work History
Manager PSMF Office, QPPV Office
Bristol Myers Squibb
03.2024 - Current
- Lead maintenance and evolution of key elements of the Pharmacovigilance System Master File PSMF
- Ensure continuous oversight of PV System and awareness of Pharmacovigilance related activities and topics to ensure seamless continuity of EEA QPPV responsibilities / BMS PV system and head of PSMF.
- Lead quality activities related to PSMF process and maintenance.
- Audit Readiness
- Participation in integration initiatives in the context of company acquisition
- Procedural documents writing
Pharmacovigilance Project Manager
Les Laboratoires Servier
10.2022 - 01.2024
- Coordination of Global signal detection for cardiovascular medicines in portfolio
- Coordination in the writing of safety reports: DSURs, PSURs, Clinical Overview, expert reports, response to questions from authorities and subsidiaries, PV surveys, or any data analysis document from security.
- Literature review
- Coordination of risk management plans (RMPs)
- Contribution to training (tutoring) in pharmacovigilance procedures: (new employees, initial and continuous training of Local PV Managers, external service providers responsible for entering/medical proofreading of case.
- As part of the core team/project teams/medical safety team: interlocutor of internal and external collaborators: for any questions relating to security of use of the product(s) for which i am responsible.
- Contribution to the development of new safety studies
Pharmacovigilance Officer
Les Laboratoires Servier
09.2019 - 09.2022
- Surveillance of the therapeutic safety of drugs in the international range
- Quality control of ICSRs
- Signal detection
- Data analysis and writing of periodic safety reports PSURs, DSURs, RMPs
Internship Pharmacovigilance Officer
Les Laboratoires Servier
09.2018 - 09.2019
Internship, Medical Data Reviewer
AB Science
04.2018 - 08.2018
- Insuring medical consistency of clinical data entered in eCRF: adverse events, medical history, vital signs, lab results...
- Medical review of significant adverse events
- Detection and review of medical and therapeutic protocol deviations
Internship
CHU Montpellier, Endocrinology Department
09.2017 - 04.2018
- Implementation of a clinical study on self assessment of diabetes
- Participation in endocrinology, diabetology and nutrition workshops
- Recruitment and follow up of patients for a clinical study on insulin pumps
Education
Doctor of Pharmacy - Pharmacy
University of Montpellier
Montpellier, France12.2021
Master's Degree: Vigilance Et Sécurité Sanitaire -
University Paris Cité
Paris, France 2019
Languages
English
Bilingual or Proficient (C2)
French
Bilingual or Proficient (C2)
Arabic
Upper intermediate (B2)
INTERESTS
Theater (Theater troupe), Sports (Running, hiking)
Timeline
Manager PSMF Office, QPPV Office
Bristol Myers Squibb
03.2024 - Current
Pharmacovigilance Project Manager
Les Laboratoires Servier
10.2022 - 01.2024
Pharmacovigilance Officer
Les Laboratoires Servier
09.2019 - 09.2022
Internship Pharmacovigilance Officer
Les Laboratoires Servier
09.2018 - 09.2019
Internship, Medical Data Reviewer
AB Science
04.2018 - 08.2018
Internship
CHU Montpellier, Endocrinology Department
09.2017 - 04.2018
Doctor of Pharmacy - Pharmacy
University of Montpellier
Master's Degree: Vigilance Et Sécurité Sanitaire -
University Paris Cité
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