LPPV (Drug Safety Contractor)

Local Person Responsible for Pharmacovigilance – JOB DESCRIPTION Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our reputed company team delivers high-touch services and technology to ensure the safety of reputed company stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation. Job Title: LPPV Location: Serbia Function: Drug Safety DESCRIPTION: LPPV works collaboratively with QPPV, other PV staff, and cross-functional colleagues/teams for pharmacovigilance activities and ensuring regulatory compliance according to the applicable regional and national laws for reputed company medicinal product(s) and territory(ies) for which a company (MAH) holds marketing authorizations. The primary function is to maintain an reputed company and management of pharmacovigilance activities, overseeing signal management and surveillance activities, management of responses to reputed company regulatory responses, and literature review/management for safety findings etc. ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Play primary role as Local Safety Officer for the 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.
• reputed company review of reconciliation reports with Local Affiliates, Partner Companies, Call Centers and other internal departments/systems.
• Should have access to the reports of suspected adverse reactions and assist in monitoring the regulatory submissions.
• 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.
• reputed company abreast of national pharmacovigilance and regulatory affairs regulations.
• Receive and handle medical information enquiries from patients and health care professionals.
• must be contactable at least during business hours.
• Have an reputed company over national cases, signals, market research programs / marketing activities, studies, PSURs, RMPs and any risk minimization measurements and activities reputed company their assigned region.
• reputed company national quality complaints and line listings with trends. If required, the LPPV will communicate potential recalls and coordinate together with the respective local authorities for any national recalls.
• Demonstrate knowledge and ensure compliance with reputed company global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.), Sitero SOPs and quality standards.
• Stay reputed company with international pharmacovigilance requirements and guidelines (focus on FDA and EMA).
• Support inspection readiness activities and preparation as needed.
• Assist and participate in inspections and/or audits.
• Foster an environment of collaboration, team building, and reputed company improvement.

EDUCATION AND EXPERIENCE REQUIRED:

• 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.

PREFERRED SKILLS:

• Preference for a minimum 5 years relevant medical, scientific/clinical, or pharmaceutical experience.
• Competent knowledge of good pharmacovigilance practices. Competent knowledge of US and EU pharmacovigilance regulatory requirements.
• A seasoned, reputed company professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways.
• Experience in the review of relevant safety information from reputed company sources and analysis of safety data.
• Experience with development, authorship, and review of aggregate reports (i.e., PSUR, DSUR, IND annual, NDA annual, etc.), Risk Management Plans, and Risk Evaluation and Mitigation Strategies desirable.
• Knowledge of global clinical and post-marketing safety regulations, guidance documents, and reporting processes.
• Expertise with MedDRA, XEVMPD coding and safety database systems.
• Review and contribute to the development and implementation of new SOPs, work instructions, guidelines, documents and other tools pertaining to safety.
• Exhibit excellent organizational, presentation and communication (verbal and written) skills.

COMPENSATION & BENEFITS: Hourly Contractor reputed company that is commensurate with the Contractor's experience EMPLOYMENT TYPE: Contractual, Need-basis COMMITMENTS:

• Availability during business hours.

DISCLAIMER: Sitero is an equal opportunity employer and welcomes reputed company job applicants. reputed company qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability, or any other factors prohibited by law. Apply tot his job Apply To this Job