07. 05. 2024

Associate Director, Medical Reviewer

RegionBeogradski region

Polje radaZdravstvo / Farmacija

Vrsta posla:Specijalističke i management pozicije


Opis
On behalf of our long-term partner, a successful pharmaceutical company, Adecco is searching for an experienced candidate:
 
Associate Director, Medical Reviewer (Drug Safety)

Responsibilities:
•    Contributes to the development of and maintenance of comprehensive and compliant medical review and medical assessment processes to drive efficiency into the medical safety review business process, introducing automation where possible;
•    Ensures implementation of new or updated regulations and/or ICH Guidelines regarding in-line medical assessment to ensure regulatory compliance for individual case safety reports;
•    Provides in-line medical assessment of individual case safety reports in the context of the available safety data and the known safety profile to assess expectedness and formulate a company statement and a causality assessment as per timelines determined by OARS workflow;
•    Provides in-line medical assessment of harm or potential harm associated with device or device-constituent to support individual case safety report (ICSR) reportability determination as per timelines determined by OARS workflow;
•    Serves as a subject matter expert for in-line medical assessment of individual case safety reports during audits and inspections;
•    Provides device legislation expertise in relation to medical review and medical assessment and reporting responsibilities;
•    Consults with TA lead Clinical Development Safety and/or Clinical Research as needed for cases requiring additional safety or clinical subject matter expertise;
•    Escalates potential safety issues to the attention of the Head Medical Safety Excellence and Safety TA Leads;
•    Contributes to the preparation and responses to Regulatory Agency Inspections as well as internal and external audits;
•    Provide input and review of responses to regulatory agency questions with regards to inline medical assessment of ICSRs Provide expert guidance on relevant PV activities outlined by procedures (SOPs, user manual, etc.);
•    Lead and/or participate in cross-functional projects as the medical safety & device subject matter expert, contributing to continuous process improvement of ICSR assessments;
•    Collaborate internally and externally on processes that ensure compliance with local and global PV regulations;
•    Assess and implement emerging regulations to ensure global alignment of in-line medical assessment of individual case safety activities and processes;
•    Participate in audit and/or inspection readiness activities and assists during the audit or inspection preparation, execution and CAPA resolution phase as needed as Subject Matter Expert;
•    Participate in external benchmarking and industry working groups to drive change across the industry;
•    Tracking and/or generation of medical review and -assessment relevant metrics and KPI monitoring.

Requirements:
•    A minimum 5 years of work experience in the pharmaceutical industry with a specific focus on pharmacovigilance related activities;
•    Strong knowledge of clinical research process, pharmacovigilance processes and end to end process of individual case safety reporting for both clinical research and Post Marketing environments;
•    Strong knowledge of interpretation of adverse experience information and regulatory legislation for medicinal products;
•    Experience in global Medical Device regulations and device safety monitoring;
•    Experience working cross culturally and actively supporting diversity.
 
Only shortlisted candidates will be contacted.
Prijavi se! Cancel

Broj oglasa JN -052024-80399