Full-Time Pharmacovigilance Specialist

Pharmacovigilance Specialist

The Specialist, Regulatory and PV Network is responsible for providing the strategy based on regulatory requirements and completing regulatory and PV deliverables based on an established PV and regulatory plan.

Serves as a liaison between regulatory and other functional areas, external partners, clients, authorities and/or consultants in the planning, organizing, and preparing of regulatory deliverables following project, corporate and industry regulatory strategies.

Acts as a Local Contact Person (LCP) for Pharmacovigilance for the designated country.

Job Responsibilities

Under the direction of a senior team member, assumes leadership and functional representation for low-complexity projects ensuring effective and rapid coordination and management of deliverables striving to meet targets and comply with procedures, trackers, and templates.

Provides intelligence on requirements and contributes to the development of strategy and set up activities (Project Management Plan, joint operating procedures, POAs, and core documents).

Supports identification of issues and corrective actions.

Collects, reviews, tracks, and maintains LCPs' CVs, job descriptions, training records, contact details, and monthly reports.

Ensures correct training assignment to and training compliance by the LCPs.

Promptly identifies and escalates risk/potential risk to the project team which may jeopardise deliverables.

Provides client expertise and guidance at a national level.

Maintains awareness of allocated tasks and hours and promptly identifies and escalates any out-of-scope (OoS) issues.

Prepares client invoices and reviews/approves vendors' project invoices.

Provides support to proposal development and input to budgets, providing department representation to BD meetings as required.

Fosters professional working relationships with internal and external contacts at local and international levels to ensure smooth and efficient service delivery.

Stays abreast of changing regulatory legislative requirements and ensures maintenance of the regulatory intelligence database and timely dissemination of pertinent changes.

Participates in preparation for audits/inspections and provides department representation for assigned projects as required.

Tracks LCPs' key performance indicators and prepares monthly summary reports.

Provides feedback on vendor performance to aid assessment.

Communicates suggestions for changes to departmental/company processes/procedures.

Qualifications

Bachelor's Degree in Chemistry or Life Sciences, Nursing, or equivalent experience.

Previous experience within the pharmaceutical/CRO industry.

PV training and/or working experience and other educational or professional background as required locally.

Language

Fluent in English, both written and verbal.

Proficient in the official language of the country of employment.

Skills

Good planning and organizational skills.

Strong interpersonal skills in a fast-paced, deadline-oriented, and changing environment.

Good attention to detail.

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