Job Description
PURPOSE OF THE ROLEResponsible person/Local Drug Safety Officer (LDSO) for p
harmacovigilance in the BeneluxDevelop and maintain a system to detect, assess,
understand and prevent/minimize adverse events or any other drug-related
ms in accordance with both EU and local legislation and company procedures.The
function must ensure that the whole local company organization is contributing
o this mission and to the global Risk Management responsibility of the Company.
KEY TASKS & RESPONSIBILITIESACCOUNTABILITY AREAPharmaceutical Affairs
Benelux: Pharmacovigilance - all TA's Regulatory Affairs relating to Clinical
Trial submissions (NL)AUTONOMY & AUTHORITYA. Responsible for all Pharmacov
igilance activities in The Benelux being but not limited to:1. Initial collec
tion of safety data and transmission to WWCS&P–Training of Company’s local per
sonnel (all employees including KAMs and Management) on collection and
sion of safety related information to the LDSO. Collaborate with WWCS&P to
ment a standard systematic local training material and presentation, and
n local accreditation to safety related matters.–Establishing local SOPs in lin
e with the Corporate SOPs–Organizing back-up and 24/7 coverage–Linking with Me
dical Information reliably-Triage and Local recording of individual cases and
timely transmission to WWCS&P–Following up serious cases2. Reporting to loca
l Authorities and Ethics Committees–Expedited reporting of Spontaneous and Cli
nical Trial cases–Periodic Reporting of cumulative data (spontaneous and Clinic
al Trial cases)–Other local submissions3. Involvement in local Post Authoris
ation (Safety) Studies (MMFM and MAST processes): -Review of the concept shee
t and study protocol at least for the indication status, the study design, the
dequacy of the safety data collection, follow-up and reporting) -Ensure that th
e study protocol, progress reports and final report are submitted to national
alth Authorities.4. Safety information requests from Health Authorities -Tr
ansmitting any safety request from HA to the appropriate Corporate and local
ctions. -Reviewing the proposed answers and ensuring timely submission. 5.
Local regulations-Keeping updated on local PV regulations and inform WWCS&P a
ccordingly.-Informing local management and WWCS&P about any relevant news in th
is area.6. Archiving and tracking of local documents:-Source documents (ori
ginal case reports in local language, full correspondence on each case).-Copies
of documents submitted to HA /ECs.7. Other-Ability and possibility to posi
tively influence Local Management in order to contribute to patient’s security,
product’s Risk Management and global company compliance. B. Responsible for Re
gulatory affairs activities (NL) relating clinical trial applications to CCMO
A) in collaboration with EU-RA, CRAs and CDO.FUNCTIONAL KNOWLEDGESpecifi
c Knowledge/experience in Pharmacovigilance, Clinical trials legislation and
rent EU/local legislation:· to be registered as Local Drug Safety Officer at He
alth authorities· to implement corporate procedures into local procedures· to
perform Adverse Event reporting as required by law and internal proceduresSome
knowledge in Regulatory Affairs and in GxP quality systems and current
ion is an advantage.BUSINESS EXPERTISE3-5 years experience in Pharmacovigila
nce in the pharmaceutical industry/health authorities or consultancy PROBLE
M SOLVINGŸ To deal with objectives, projects and customers in a organized and
business focused wayŸ Be able to act and work in a solitary capacity as well as
in teams and be able to make decisions.Ÿ Keep the line manager informed about
the progress of projects and involved in case of serious issues.Ÿ Be able to
deal in a practical way with all applicable laws and regulations and internal
oceduresŸ Ability to work in a multifunctional environment, negotiating skills
with other local functions, ability to create and maintain strong and trustful
elationship with corporate groups, pro activity, total professional integrity.
EDUCATION/LANGUAGESBoth written and verbal:DutchEnglishSome knowledge of F
rench is an advantagePROFESSIONAL SKILLS & EXPERIENCEScientific ((bio)medic
al or pharmaceutical) qualified with experience in the pharmaceutical industryE
xperience in pharmacovigilancePERSONAL SKILLS & COMPETENCIESPlanning and or
ganization skillsBeing able to pay attention to detailsWell developed analytic
al skillsStress resistantTeam playerCustomer focusedGood communication skill
sStrong interpersonal skillsWillingness to travel sometimes for international
meetings and courses.
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