Pharmacovigilance Specialist, NQPPV Deputy Serbia
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Job Location:
Monthly Salary:
Posted on:
17 hours ago
Vacancies:
1 Vacancy
Job Summary
Join AbbVie as the Pharmacovigilance (PV) Specialist serving as the National Qualified Person for Pharmacovigilance (QPPV) Deputy for this key compliance role you will be accountable for executing the day-to-day operations and compliance activities to maintain high-functioning PV systems across Serbia and Bosnia and Herzegovina.
You will directly support the maintenance and oversight of our local PV system ensuring alignment with AbbVies global standards and Serbian regulatory requirements. Appointed as the National QPPV Deputy in Serbia you will have authority to influence the performance of the quality system and PV activities and to promote maintain and improve compliance with the legal requirements.
Key Responsibilities:
- Oversee and maintain accuracy of the Pharmacovigilance System Master File (PSMF) ensuring all documentation is up-to-date and compliant.
- Support the provision of metrics that will ensure oversight of all aspects of the performance and functioning of the PV system in compliance with local regulations and internal company timelines/standards.
- Develop and maintain local and regional SOPs and procedures in alignment with AbbVies corporate guidance and local legislation.
- Manage Individual Case Safety Reports (ICSRs): processing conducting follow up expedited reporting quality control reconciliation and tracking. Perform medical or scientific literature review.
- Periodic safety reporting (e.g. PSURs DSURs SUSAR Line Listings): review preparation submission and evidence documentation.
- Lead/support internal PV audits regulatory inspections and CAPA processes including timely action tracking to completion.
- Ensure all PV requirements are in place for activities where there is a reasonable possibility for the identification and/or handling of safety information in accordance with AbbVie procedures and local requirements.
- Oversee PV training compliance and the development/maintenance of the PV training materials and training matrix.
- Monitor and assess changes in local/regional PV legislation ensuring prompt impact assessment and implementation.
- Lead/support affiliate risk management activities including RMPs aRMM and local implementation plans.
- Ensures availability to be at AbbVies disposal continuously on a 24-hour basis and that an after-hours process is in place for the reporting of AEs and that a Business Continuity Plan is established to allow for continuation of critical business processes for PV.
Qualifications :
- Degree qualifications from Faculty of Medicine Faculty of Pharmacy or Faculty of Dental Medicine (dentistry).
- Resident of Serbia.
- Fluent in Serbian and a strong command of English.
- A minimum of 1 year of experience in the pharmacovigilance field is required.
- In-depth knowledge of Serbian PV regulations and GVP requirements.
- Strong organizational analytical and communication skills.
- Ability to work independently with high attention to detail and compliance.
- Multilingual capabilities particularly proficiency in the Slovenian language will be regarded as an advantage.
Additional Information :
We offer a very dynamic environment abundant opportunities for professional growth and development exposure to diverse cultures within the region and the chance to collaborate closely with senior leaders. This combination creates a unique and rewarding workplace where individuals can learn contribute and advance their careers. Ready to make an impact Apply now and help us ensure the highest standards of product safety for patients.
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Key Skills
- Sales Experience
- Crane
- Customer Service
- Communication skills
- Heavy Equipment Operation
- Microsoft Word
- Case Management
- OSHA
- Team Management
- Catheterization
- Microsoft Outlook Calendar
- EHS
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
