Support PV activities within the MEAP hub coverage areas to ensure activities are completed consistently in a timely manner in accordance with internal processes and local and international regulatory requirements. Overall scope consists of providing support to Affiliate Safety Representatives (ASR) in oversight of Pharmacovigilance (PV) activities, primarily in:
Maintaining PV related activities to meet Abbott’s statutory Pharmacovigilance responsibilities.
Performing ICSR processing and quality checks as needed
Keeping relevant databases, archives and trackers up to date
Supporting PV hub team in maintaining standards and implementing improvements
Participating in PV project work when deemed necessary
Ensuring audit and inspection readiness and effective CAPA development relevant to hub operational activities
Complying with company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives Abbott Laboratories
CORE JOB RESPONSIBILITIES
Individual Case Safety Report (ICSR) management (that is, receipt, documentation, forwarding to GPV, tracking, expedited reporting, etc)
Collection of safety data and other PV-related responsibilities in relation to interventional studies (clinical trials)
Collection of safety data and other PV-related responsibilities in relation to organized data collection schemes (that is, non-interventional studies, registries, patient support programs, market research programs, etc. )
Handling of inquiries relating to product safety including regulatory authority inquiries
Handling of safety information arising from product complaints
Write PSURs, PSSFs, HHA and RMPs and other key documents for Local Products
Ensure local adaption of PSURs/PBRERs (Developing National Appendix) and RMPs (Developing National Displays)
Safety signaling activities
PV Agreements handling and maintenance
Review scientific literature, social media and bibliographic sources;
Monitor Affiliate PV system performance and compliance, and resolve nonconformities
Support internal PV audits and inspections from regulatory authorities.
Maintain (an) accurate local products list(s) to clearly show the product status: global or local – as defined per the GPV-all product list.
Handle MOH PV Submissions
Assist with pharmacovigilance processes, trainings, writing of SOPs, product safety reviews as required
Consideration of PV matters during locally performed due diligence activities and locally negotiated contractual agreements, and exchange of safety information as defined in safety data exchange agreements
Ensure record retention (archiving)
Pharmacist Degree is a must
Clinical Research Experience is a plus
Minimum 2 years of relevant experience in Pharmacovigilance
Knowledge of pharmacovigilance procedures, policies and standards
Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity
Detailed oriented, communication, compliance and process Improvement skills.
Proficiency in English & Arabic languages; French is a Plus.
Computer Knowledge: Knowledge of the Office package (Ms Word, Ms Excel, Ms Power Point)
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email Apply to send email to the employer