ALK is on an ambitious journey to become the preferred allergy company globally and therefore we are looking for a Pharmacovigilance Manager to join our Benelux team in the Netherlands. The PV Manager / Deputy National Person responsible for PV (d-NPPV) supports the National Person responsible for Pharmacovigilance (NPPV) with responsibilities including (but not limited to): maintaining ALKs PV Quality System, recording and processing of ICSRs; ensuring all ALK Benelux staff are trained and up to date with the relevant SOP’s,
Due to expansion of our company we are looking to recruit a PV Manager / Deputy-NPPV who will be reporting to NPPV.
ecording, processing, evaluation and follow-up (obtaining further information) of drug risks such as side effects and pharmaceutical-technical complaints from The Netherlands, Belgium and Luxemburg
upport of the nationally responsible person for pharmacovigilance (Benelux) in their tasks for The Netherlands, Belgium, and Luxemburg (e.g., market research projects, social media projects, investigator-initiated trials, non-interventional studies, Implementation of pharmacovigilance Agreements and trainings for external business partners, revision of SOPs, etc.)
nsuring good and effective cooperation in the Pharmacovigilance Europe team as well as with the Global Pharmacovigilance department in Denmark and with other international pharmacovigilance and QA departments
upport in case of audit(s) of internal and external vendors.
aintaining a local PV system in collaboration with PV staff.
e aware of any websites or blogs under the responsibility of ALK-Abello B.V. and assure that local procedures are in place so that information about adverse events from these digital media are brought to the attention of the NPPV to be forwarded to GPV.
hen safety information is received that is suggestive of a serious or non-serious adverse event, ALK-Abello B.V. will record the date the information is provided and details about the event. All attempts to get further information should be documented in a similar fashion.
aintain the original single case paper files at the affiliate according to local SOPs and provide paper files for Adverse Drug Reactions (ADR) reports to GPV upon request.
ollect single cases (ADRs, solicited reports, complaints etc. as described in previous sections).
aintain PV tracking system of collected and potential ADRs at affiliate.
n case of non-interventional studies performed in country ensure the reporting of Adverse Events/Serious Adverse Events (AEs/SAEs) described in the protocol, Corporate SOPs and trial or study specific agreement is adhered to.
equesting additional information from reporter (e.g., the Health Care Provider or Consumer) of Individual Case Safety Reports (ICSR) if requested from GPV for assessment of cases.
erform reconciliations with Global PV and relevant internal and external stakeholders.
rchiving PV related documentation according to the local archiving SOP.
ssist the NPPV with PV trainings for all internal stakeholders to ensure staff are trained in how, where and when to report ICSRs.
achelor’s Degree in Life Sciences or related discipline preferred e.g. human biology, nurse, pharmacist
inimum 3 years’ experience within pharmacovigilance
luency in spoken as well as written English
amiliar with basic computer skills (Microsoft Office)
bility to interact and communicate effectively with internal and external stakeholders
bility to work both independently and within a team
bility to maintain confidentiality of data and information during interactions with staff at all levels.
quality mindset, an eye for details, can work under pressure/short timelines