Specialist, Quality

The Pharmacovigilance (PV) Specialist supports the Marketing Authorisation Holder (MAH) entities of the Cosmo group ensuring their compliance with pharmacovigilance duties of the MAH.
The role acts as the key liaison point between Cosmo and the external, contracted pharmacovigilance (PV) service providers, managing pharmacovigilance responsibilities with distributors and commercial partners, and ensuring that all contractual, regulatory, and quality obligations are met. The position ensures that the MAH maintains ultimate accountability for patient safety and regulatory compliance, while delegating operational activities to an external, contracted PV service provider. The position ensures safety reporting obligations from and to territories where products are marketed outside the EU, in line with contractual agreements and MAH responsibilities.
The position reports to the Chief Scientific Officer, and liaise with the Global Head of Regulatory Affairs to align PV activities with regulatory tasks and duties of Cosmo’s entities acting as MAHs.

Responsibilities of the position
To ensure that the PV provider is notified of any changes to Market Authorisations held by Cosmo within the timeframes stipulated in the agreement and is aware of all new territory requirements and partners providing assistance as well to assess the requirements for local contact personnel in all territories and ensure all responsibilities are being made according to local legislation and suitable agreements are in place with vendors/partners to provide these services.
To ensure timely reporting of adverse events (AEs), serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs), and periodic safety update reports (PSURs/PBRERs) in accordance with global regulatory requirements.
To develop and maintain PV SOPs in line with national and international requirements to cover all relevant PV responsibilities and ensure that these are shared with the QPPV.
To take responsibility for identifying all partners and vendors that are part of the PV system in order to ensure that due diligence and ongoing risks are monitored, and a suitable audit program is implemented.
To notify the QPPV of any issues arising from audits or inspections of Cosmo or any of their partners and to exchange relevant information including reports within the agreed timeframes and work with the PV provider and QPPV to assist in making decisions regarding potential signals and required actions.
To ensure that a procedure for product recall is in compliant with PV requirements and managed appropriately at Cosmo.
To provide data for the Cosmo PSMF as per the agreement and review and sign off it on a quarterly basis to ensure that the document is inspection ready at all times.
To be aware of requirements for updates to Risk Minimisation Plans and of aggregate report requirements in all territories (i.e. PSURs, PBRERs and DSURs) and provide the required information to the PV provider.
To review compliance and Key Performance Indicators (KPIs) relating to pharmacovigilance and attend regular meetings with the PV provider and act as the key point of contact for PV queries at Cosmo for the PV provider, QPPV and Cosmo third parties.
To ensure audit readiness for both MAH and vendor-related PV activities and to support regulatory inspections by ensuring documentation and vendor oversight evidence are available.

Qualification
A BS degree in a biomedical or related life science.
Minimum 2–3 years’ experience in pharmacovigilance, preferably with vendor management/ oversight and commercial partners exposure.
Excellent knowledge of EU GVP requirements and international PV regulations: good working knowledge of medical terminology is preferable.
Familiarity with pharmacovigilance system audits, inspections, and SDEAs.
Willingness to travel for business (less than 20% of time)
Excellent oral and written communication, organizational and planning skills
Excellent English skills, written and spoken.
Excellent computer skills and experiences in the use of standard office programs (Word, Excel, Power Point, etc.)


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The research complies with Legislative Decree 198/2006