Description

Pharmacien avec une expérience de 8 ans dans le domaine de la pharmacovigilance au sein de 2 multinationales (Novartis et BMS), j’ai un domaine d’expertise s’étalant sur plusieurs sujet de la PV allant de la rédaction des rapports de sécurité pour les accès précoce, la gestion opérationnelle de ces projets, la rédaction de RMP locaux, de PSMF et PSSF, l’implémentation des MARR, la gestion des KPI, le case processing, l'audit ainsi que la préparation d’audit et d’inspection …

Grace à mon expérience et à ma capacité d’adaptation et de travail en équipe je pourrai gérer vos projets en rapport avec la PV d’une façon tout à fait autonome.

Languages

English
Native or bilingual
French
Native or bilingual
Arabic
Native or bilingual

Workplace preferences

Remote only

Primarily works remotely

Oribase Health Sciences
pharmacovigilance consultant and founder
PHARMACEUTICALS INDUSTRY
September 2022 - Today (3 years and 9 months)
Pharmacovigilance Auditor for Cooper in Tunisia: Conducted a
comprehensive audit of one of their distributors in Tunisia.
 Consultant for the implementation of pharmacovigilance systems within
5 different pharma companies in Tunisia in the framework of the new
pharmacovigilance Tunisian guidelines:
o Pharmacovigilance procedures writing
o PSMF (Pharmacovigilance System Master File) writing
o RMP (Risk Management Plan) writing
o PSUR (Periodic Safety Update Report) Writing
 Support of a Medical and Scientific Information Agency by elaborating
their Pharmacovigilance and Quality system in the framework of their audit
preparation
 Outsourced QPPV for a local company
 Pharmacovigilance trainer in association to the National Center of Pharmacovigilance
of Tunisia and to BiotechPole Sidi Thabet the framework of
the new pharmacovigilance Tunisian guidelines. Trainer Topics: implementation
of a PV system, RMP, PSUR, PSMF, signal detection more than
45 persons took part to these 6 days training
 Instructed and delivered a course on 'Critical Procedures for Establishing
a Pharmacovigilance System' at the Faculty of Pharmacy, Monastir, as part
of the Master's Program in Technological Innovation, Management, and
Engineering Applied to the Pharmaceutical Industry.
Bristol-Myers Squibb
Manager Patient Safety
MEDICAL
July 2021 - June 2022 (11 months)
Operational management of early access program (ATUs/AAP) including
CRO interactions
 Draft the ATU PV part of periodic summary reports
 Local France PV cases analysis, local signal detection (Onco-hematology
products including CAR -T Cell product)
 Involvement in the design and implementation of risk minimization tools
 Provide Inputs and review for ATU/AAP regulatory documents to ensure
necessary process and controls on collection and reporting of adverse
event
 PV Quality task (Deviation and CAPA)
 PV compliance tasks (KPI)
 Audit and inspection preparation
 Country regulation screening with associated impact analysis
 Implementation of new requirements / processes within the merge with
BMS (case management - new PV base including CNIL requirements,
safety report, risk management, procedural document)
 Implementation and follow-up of change controls
Novartis
Senior patient Safety specialist
MEDICAL
August 2016 - July 2021 (4 years and 11 months)
 As LSR, act as single Pharmacovigilance contact point for the national

medicines authorities on a 24-hour basis and as contact point for
Pharmacovigilance inspections.
 PSSF preparation in accordance with global PSMF.
 Local RMP preparation.
 Literature screening and related signal detection.
 Development, update and implementation of local procedures in accordance
with Patient Safety global procedures and national requirements.
 Management of the collection, processing, documentation, reporting and
follow-up of all adverse event reports for all Novartis products from clinical
trials, non-interventional studies, Patient Oriented Programs, literature,
Spontaneous Reports, etc.
Participation to an audit as co auditor for an external partner
(Review of pre-documentation, participation to interviews of the
auditees, drafting some parts of the audit report…)
 Audit and self-inspection preparation.
 Preparation and submission of KPI reports in a timely manner including
identification of root cause(s) for late reporting to LHA, development and
implementation of corrective action(s) as needed
 Management of reporting/submission/distribution of safety reports/updates/
information (e.g. SAE, SR, IN/SUSAR, Biannual SUSAR Listing, DSUR)
to Local Health Authorities
 Provide Inputs, review and approval of program proposals (POP, Digital,
Clinical Trial) for language, content and establishment of necessary controls
on collection and reporting of adverse event information.
 Perform reconciliation with other departments (e.g. Medical Information,
Quality Assurance and third party contractor, if applicable) for potential
AEs
 Develop and update training materials for pharmacovigilance and ensure
training of Country Organization associates on relevant Patient Safety
procedures for AE reporting.