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    Pharmacovigilance Specialist

    Organon
    +1 years
    Not Disclosed
    Prague
    10 Nov. 24, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

     

    Job Description: Pharmacovigilance Specialist

    Organization: Organon
    Location: Eastern Europe and Israel (EEI Cluster)
    Travel: Limited

    Position Overview

    The Pharmacovigilance (PV) Specialist oversees all PV activities for their assigned product portfolio, ensuring compliance with local laws, regulations, and company standards. Responsibilities include adverse event case management, supporting PV processes, conducting audits, and collaborating with cross-functional teams. This role ensures seamless drug safety oversight with no gaps in reporting and contributes to process improvements.

    Key Responsibilities

    Adverse Event Case Management

    • Manage daily case intake and follow-up activities in compliance with global PV procedures and local regulations.
    • Process individual case safety reports (ICSRs), including translation to English, tracking, acknowledgment, and reconciliation activities.

    PV Process Execution

    • Ensure execution of PV processes, aligning with Quality Management Systems and local legislation.
    • Perform reconciliation of PV cases from internal and external sources, ensuring accuracy and compliance.

    Documentation & Archiving

    • File, store, and archive safety-related data per company policies and local requirements.
    • Ensure documentation is readily available for audits, inspections, and compliance reviews.

    Audits & Inspections

    • Support local PV audit readiness and participate in inspections.
    • Develop corrective and preventative actions (CAPAs) for compliance issues and support audits of contractual partners/vendors.

    Collaboration & Stakeholder Engagement

    • Partner with local business units to align safety activities with strategic decisions, such as new product launches or clinical trials.
    • Liaise with vendors and business partners for activities related to Patient Support Programs (PSP) and Market Research.

    Process Improvement

    • Identify procedural gaps and implement solutions to improve efficiency and effectiveness.
    • Assist in developing local PV procedures that align with regional and global standards.

    Risk Minimization & Compliance

    • Support the implementation and oversight of local Risk Minimization Measures (RMMs) and Additional Risk Minimization Measures (ARMMs).
    • Ensure PV requirements are met in agreements and maintain compliance with Business Development and Licensing Management (BDLM).

    Competencies

    Collaboration and Partnering

    • Demonstrates ability to work effectively with internal and external teams to achieve quality goals.

    Communication Skills

    • Communicates effectively in English and Czech, ensuring clarity in written and verbal interactions.

    Problem Solving

    • Proactively identifies and resolves challenges using creative and structured approaches.

    Project Management

    • Effectively prioritizes tasks and utilizes resources to meet PV timelines and regulatory requirements.

    Decision Making

    • Makes informed decisions, escalating issues appropriately, and leveraging data and networks for rapid resolution.

    Regulatory and Compliance Management

    • Demonstrates a strong understanding of PV regulations, trends, and industry standards.

    Required Education, Experience, and Skills

    Education

    • Bachelor’s degree in Health, Life Sciences, or Medical Sciences.

    Experience

    • Minimum 1 year of pharmacovigilance experience in the pharmaceutical industry.
    • General knowledge of PV regulations in assigned countries and expertise in PV processes.

    Skills

    • Proficient in English and Czech (written and spoken).
    • Strong organizational, time management, and problem-solving skills.
    • Ability to work independently and collaboratively across multiple teams and stakeholders.

    Preferred Education, Experience, and Skills

    • Proficiency in regulatory and compliance frameworks for pharmacovigilance.
    • Experience in supporting audits and implementing CAPAs.
    • Advanced communication and interpersonal skills for cross-functional collaboration.

    About Organon

    Organon is a global healthcare leader committed to delivering innovative health solutions. With a focus on women’s health, biosimilars, and trusted health products, Organon aims to create a healthier world for women and their families. We are dedicated to fostering a diverse and inclusive workplace where everyone can thrive.

    Employment Details

    • Status: Regular
    • Relocation Assistance: Domestic
    • Visa Sponsorship: Not available
    • Work Arrangements: Flex Time

    Organon is an equal opportunity employer and encourages applicants from all backgrounds to apply.

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