Manager, PV Operations

Manager, PV Operations

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 experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation. 

Job Title: Manager, PV Operations

Location: Japan

Function:  Drug Safety

DESCRIPTION:

Local PV Officer works collaboratively with Global PV staff, and cross-functional colleagues/teams for pharmacovigilance activities and ensuring regulatory compliance according to the applicable regional and national laws for all medicinal product(s) and territory(ies) for Sitero is responsible. The primary function is to perform translations of the incoming information (safety / non-safety), managing and supporting pharmacovigilance activities such as conducting non-English follow ups for gathering safety information, local case report distributions & NCA submissions.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Perform translations and/or quality review of the translations (manual / automated) of the incoming information (safety / non-safety).
• Perform accurate, complete, and timely translation of safety-relevant information
• Perform end-to-end case processing and literature surveillance
• Ensure compliance with international and local guidelines (like GDPR & and applicable data protection laws) into account.
• Should have access to the reports of suspected adverse reactions and assist in monitoring the regulatory submissions.
• Perform non-English follow-ups via phone, email etc.
• Support in preparation of submission packages (local forms in local languages) for local Health Authority case submissions.
• Keep abreast of national pharmacovigilance and regulatory affairs regulations.
• Receive and handle medical information enquiries from patients and health care professionals.
• Must be contactable during business hours.
• Demonstrate knowledge and ensure compliance with current global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.), Sitero SOPs and quality standards.
• Stay current with international pharmacovigilance requirements and guidelines.
• Foster an environment of collaboration, team building, and continuous improvement.

EDUCATION AND EXPERIENCE REQUIRED:

• Fluent in source and target language (native or near-native in target language)
• Excellent written communication skills
• Trained in pharmacovigilance terminology
• Documented PV training (e.g., SOP training, GVP awareness)
• Understanding of medical terminology (medical degree not required, but experience is)

PREFERRED SKILLS:

• Preference for a minimum 2 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, experienced 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 all sources and analysis of safety data.
• 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.

EMPLOYMENT TYPE:

Full-time

COMMITMENTS:

• Availability during local business hours.

DISCLAIMER: 

Sitero is an equal opportunity employer and welcomes all job applicants.  All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.