The Associate Specialist, PV is responsible for undertaking specified PV activities (as delegated/assigned by their manager) and with oversight by their manager or a designated PV colleague. The Associate Specialist, PV is responsible for ensuring adherence to all applicable regulations, company policies and procedures.
Responsibilities:
Assists with execution of local PV processes and activities in collaboration with internal functional areas and external parties as assigned. Activities may include but are not limited to management of local PV agreements, local due diligence activities, Post approval Safety Monitoring Program (PSMP) implementation, scheduling and submitting aggregate safety reports.
Assists with day-to-day adverse events case management which may include case intake (where needed), translations (English and/or local language, (as applicable)), acknowledgments, follow-up and submission activities in accordance with PV procedures and country regulations.
Supports local PV audits and inspections when requested.
Participates in issue management/compliance activities and assists in coordinating/preparing the necessary local corrective actions.
Supports development and maintenance of local PV procedures and controlled documents.
Supports PV self-inspections as required by PV Legislations (where applicable).
Supports appropriate implementation and oversight of Risk Minimization Measures and Additional Risk Minimization Measures locally as per local procedure and local legislations.
May be responsible for managing and performing local literature screening and assessment in accordance with company procedure and local requirements (as applicable).
Support local implementation of applicable business continuity plans.
Translates or QCs translation of applicable PV documents.
Responsible for filing, storage and archiving of safety-related documentation in accordance with company policies and local requirements.
Participates in special projects or rotational assignments within or outside of IPV as part of their professional development.
Responsible for completing all required/applicable trainings assigned at time of hire and after hire, by the due dates and before performing the activity.
Requirements: Education:
Health, life science, or medical science degree or equivalent by education/experience (Hiring Manager discretion permitted).
Work Experience:
Experience in the pharmaceutical industry is preferred (Hiring Manager discretion permitted).
General knowledge of AE reporting requirements and relevant PV regulations.
Job-specific competencies & skills:
Must be fluent in English (written and spoken) while proficient in local language.
Good communication, organizational, and time management skills.
Required Skills:
Adverse Event Report, Adverse Event Report, Adverse Events, Biological Sciences, Business Continuity, Communication, Compliance Investigations, Data Analysis, Data Management, Data Processing, Data Quality Assurance, Detail-Oriented, Drug Safety Surveillance, Employee Training Programs, English Language, Issue Management, Life Science, Microbiology, Pharmaceutical Management, Pharmacovigilance, Policy Implementation, Protocol Development, Regulatory Communications, Regulatory Compliance Audits, Regulatory Compliance Consulting {+ 1 more}
This position is open to all candidates.