LPPV - Drug Safety

1w1 week ago

Sitero LLC

Belgrade, RS · Contract · €45,000 – €75,000

About this role

Sitero is an emerging leader in clinical services and software solutions for the life sciences industry. The LPPV works collaboratively with QPPV, other PV staff, and cross-functional teams to ensure regulatory compliance for medicinal products where the company holds marketing authorizations. Primary functions include oversight of pharmacovigilance activities, signal management, and literature review for safety findings.

The role involves serving as Local Safety Officer for regions including Serbia, Montenegro, Albania, Macedonia, and Kosovo. Daily tasks include managing collection and processing of safety information, reviewing reconciliation reports, and monitoring regulatory submissions. Responsibilities extend to handling medical information enquiries and ensuring regular local literature reviews.

Collaboration occurs with local affiliates, partner companies, health authorities, and internal departments. The LPPV maintains oversight of national cases, PSURs, RMPs, and risk minimization activities. Communication with health authorities and support for aggregate reports are key team interactions.

Stay current with global PV regulations like CIOMS, EMA, FDA, and ICH, plus Sitero SOPs. Support inspection readiness, participate in audits, and foster continuous improvement. The role emphasizes ethics, compliance, and innovation in clinical research safety.

Requirements

Degree in Medicine, Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background and proven competence in drug safety
Master’s or Doctorate level degree preferred
Preference for a minimum 5 years relevant experience
Knowledge of current global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH)
Familiarity with national pharmacovigilance and regulatory affairs regulations
Experience staying current with international pharmacovigilance requirements (focus on FDA and EMA)
Ability to manage pharmacovigilance activities including signal management and surveillance

Responsibilities

Serve as primary Local Safety Officer for assigned regions: Serbia, Montenegro, Albania, Macedonia, and Kosovo
Ensure compliance with local guidelines and regulations applicable to MAH product portfolio
Support writing and compilation of various Aggregate Reports and regulatory filings
Perform review of reconciliation reports with Local Affiliates, Partner Companies, Call Centers, and other internal departments/systems
Manage end-to-end collection and processing of safety information for single case and aggregate report requirements
Ensure regular monitoring of local literature reviews
Manage relationships and communicate with local Health Authorities
Oversee national quality complaints, line listings with trends, and coordinate potential recalls with local authorities