PV/QA & Compliance Manager- Pharma

Náplň práce, právomoci a zodpovednosti

• Management of ADRs – reporting, archiving.
• Management of PSUR, RMP, EdM and DHCP (and other RMM) in collaboration with ŠUKL.
• Distributions of information on risk minimization measures to relevant departments.
• Monitoring of local literature and webpages for safety issues.
• Planning and providing PV/quality and products complaints training for SK employees.
• Monitoring of local processes and changes in collaboration with SUKL, regular monitoring of SUKL and MoH webpage.
• Contribution on processing, reporting changes in the safety and quality issues of products.
• 24 hours availability for safety issue communication
• Evaluation of PV aspect of local NIS, MR and IIT including the PV training of external providers (if applicable).
• Responsibility for regular updating company´s databases/systems.
• Create Standard Operating Procedures (SOP) and generate and maintain local system Hermés/SOP Guard.
• Involvement in the approval of promotional materials in the local system.
• Participation in audit and inspection activities.

Compliance

• Supporting the implementation global compliance projects and initiatives in the country with guidance from Legal & Compliance Department in Vienna.
• Implementation of GDPR, Anti-Bribery and Code of Conduct rules into day-to-day processes, including regular updating of forms and contracts.
• Implementation and responsibility for communication & training for employees regarding compliance content.
• Regular review/update of local policies/SOPs (if any) related to compliance & data protection.
• Participation in training and educating sessions for both areas.

Osobnostné predpoklady a zručnosti

• min. 3 ročná skúsenosť na podobnej pozícii -potrebná
• skúsenosť vo pharmacovigilancii, quality a compliance- potrebná
• výborná znalosť farmaceutického prostredia, zákony, legislatíva, GDPR
• príjemné a kultivované vystupovanie
• cit pre detail, precíznosť a zodpovednosť
• pokročilá úroveň AJ
• vedieť zvládať viac rôznych úloh naraz