Job Title: Local Person Responsible for Pharmacovigilance (LPPV)
Location: Serbia (Remote)
Department: Drug Safety Services
Employment Type: Contractual, Need-Based
Work Schedule: Availability required during business hours
Compensation: Hourly contractor rate commensurate with experience
Experience Required: Minimum 5 years of relevant experience in pharmacovigilance, clinical safety, or drug safety operations within pharmaceutical, biotechnology, or clinical research organizations.
Role Overview
The Local Person Responsible for Pharmacovigilance (LPPV) collaborates with the Qualified Person for Pharmacovigilance (QPPV), pharmacovigilance teams, and cross-functional stakeholders to ensure compliance with regional and national regulatory requirements for medicinal products where the Marketing Authorization Holder (MAH) maintains authorization. The role provides oversight and management of pharmacovigilance activities, including signal management, safety surveillance, regulatory response management, literature review, and risk management processes across assigned territories.
The LPPV serves as the primary local safety contact for assigned regions and ensures effective implementation of global pharmacovigilance standards and local regulatory obligations.
Key Responsibilities
Serve as the primary Local Safety Officer for assigned regions including Serbia, Montenegro, Albania, North Macedonia, and Kosovo.
Ensure compliance with local pharmacovigilance regulations and guidelines applicable to the MAH product portfolio.
Support preparation, writing, and compilation of aggregate safety reports and regulatory submissions.
Review reconciliation reports with local affiliates, partner organizations, call centers, and internal systems.
Access and review reports of suspected adverse reactions and support monitoring of regulatory submissions.
Manage end-to-end collection, processing, and reporting of safety information for individual case safety reports and aggregate reporting requirements.
Conduct and oversee regular local literature monitoring and safety data surveillance.
Maintain communication and manage relationships with local health authorities.
Stay updated on national pharmacovigilance and regulatory requirements.
Handle medical information inquiries from patients and healthcare professionals.
Provide oversight of national safety cases, signal detection activities, market research programs, post-marketing studies, PSURs, Risk Management Plans (RMPs), and risk minimization activities.
Monitor national quality complaints, identify safety trends, and coordinate potential product recalls with local authorities when required.
Ensure compliance with global pharmacovigilance regulations and guidelines, including CIOMS, EMA, FDA, and ICH standards, and adhere to Sitero SOPs and quality standards.
Support inspection readiness activities and participate in audits and regulatory inspections.
Promote collaboration, continuous improvement, and quality enhancement within pharmacovigilance operations.
Education and Experience Requirements
Bachelor’s or advanced degree in Medicine, Pharmacy, Nursing, Epidemiology, Biosciences, or an equivalent healthcare discipline with pharmaceutical industry experience.
Master’s or Doctorate degree preferred.
Proven competence in drug safety and pharmacovigilance operations.
Minimum 5 years of relevant experience in medical, clinical, scientific, or pharmaceutical environments, particularly in pharmacovigilance or drug safety roles.
Preferred Skills and Qualifications
Strong knowledge of Good Pharmacovigilance Practices and global drug safety regulations, including US FDA and EU regulatory requirements.
Experience in safety data review, signal detection, and analysis of safety information from multiple sources.
Experience in development, review, and submission of aggregate reports such as PSURs, DSURs, IND Annual Reports, NDA Annual Reports, Risk Management Plans, and Risk Evaluation and Mitigation Strategies.
Knowledge of global clinical and post-marketing safety regulations, reporting processes, and regulatory guidance documents.
Experience with MedDRA and XEVMPD coding and safety database systems.
Ability to contribute to development and implementation of SOPs, work instructions, and safety documentation.
Strong organizational, analytical, and communication skills with attention to regulatory compliance and quality standards.
Equal Opportunity Statement
Sitero is an equal opportunity employer and welcomes applications from all qualified candidates. All employment decisions are made without discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other status protected by applicable law.
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