Senior Pharmacovigilance Specialist

Med Communications International; Lisboa; Teletrabalho; EUR 40 000 - 60 000; Tempo integral

Resumo da oferta

A global healthcare company is seeking a Senior Pharmacovigilance Specialist to work remotely from Portugal or nearby countries. The ideal candidate will possess an advanced degree in pharmacy and at least three years of experience in pharmacovigilance. Responsibilities include processing safety information, preparing safety reports, and ensuring compliance with regulations. Strong knowledge of safety systems and excellent communication skills are essential.

Qualificações

• Minimum of three years related experience in pharmacovigilance.
• Preferred experience with drugs, medical devices, vaccines, and biologics.
• Excellent knowledge of ICH GCP and other ICH/EMA/FDA and local PV regulations.

Responsabilidades

• Demonstrate proficiency in safety database and coding.
• Process and monitor safety information appropriately.
• Contribute to safety reports (DSUR, PSUR/PBRER, etc.).

Conhecimentos

Attention to detail

Self-Motivated

Problem Solving

Customer Oriented

Communication, Written

Communication, Oral

Active Listening

Accuracy

Technical Aptitude

Organized

Formação académica

Advanced degree in pharmacy (PharmD preferred)

Relevant pharmacovigilance experience

Ferramentas

Oracle Argus Safety

ARISg

Microsoft Office

Embase

Ovid Medline

PubMed

SafetyEasy

Descrição da oferta de emprego

Overview

Senior Pharmacovigilance Specialist - Remote

Highlights:

• Pre and post marketing PV experience
• PV Planning in clinical trials
• DSUR, PSUR/PBRER
• RMP writing

Responsibilities

• Demonstrate proficiency in the use of the safety database and associated safety system(s).
• Demonstrate proficiency with MedDRA and WHODrug coding.
• Integrate scientific expertise with knowledge of safety database functions to ensure accurate and comprehensive case data entry and identification of follow-up requirements for all case types, received from multiple sources (spontaneous, clinical trial, post-authorization safety studies, scientific literature, etc.).
• Monitor the client email inbox, perform review, analysis, triage and filing of safety information within established timeframes.
• Process safety information in the relevant computerized system (e.g., PV database): data entry, MedDRA and WHODrug coding, case narrative writing, quality control, reconciliation, per client requirements.
• Ensure quality, compliance, and consistency of all steps of case processing activities (case management).
• Collaborate with the Medical Reviewer to collect required information and determine AE medical assessment.
• Complete medical literature search activities for pharmacovigilance purposes.
• Complete social media search activities for Client products for pharmacovigilance purposes, if needed.
• Contribute to and/or assist in preparation of expedited and periodic safety reports (including SUSAR, DSUR, line listings, IND safety reports).
• Assist in writing aggregate safety reports (PSURs/PBRERs, ADCOs, PADERs), DSURs, risk management plans and signal detection reports.
• Apply regulatory and compliance guidelines to ensure expedited and non-expedited submissions to appropriate entities.
• Create and review ad-hoc reports from the safety system and tools.
• Perform quality reviews of periodic reports, ad-hoc reports, and data retrieved from the safety system.
• Assist as a member of the safety management team in determining whether new safety information requires amendment to Clinical Trials documentation.
• Develop PV documentation including SOPs, work instructions, and Safety Management Plans under supervision.
• Ensure PV documents are filed according to SOPs and project requirements.
• Communicate with internal and external stakeholders and participate in team meetings.
• Maintain and develop professional knowledge through trainings and self-learning; share knowledge with PV team and Clients to promote patient safety.
• Act as a mentor and trainer for new PV employees, performing content quality checks and supporting issue solving.
• Participate in staff training to ensure adherence to Client quality guidelines and KPIs.
• Support the role of the QPPV and interact as required.
• Assist in collection, verification, and tracking of local and global safety reporting requirements.
• Demonstrate ongoing scientific and business expertise relevant to therapeutic areas and regulatory landscapes.
• Comply with applicable guidelines, policies, legal, regulatory, and compliance requirements.
• Meet or exceed service levels and targets for internal and external customers.
• Work with the PV Team Leader to identify areas of process improvement for processing incoming data and Client information.
• If required, assume responsibility for PV projects implementation and maintenance as Implementation Leader or Team Leader.
• Coordinate PV activities to ensure timely and adequate workload distribution for the team.
• Contribute to overall compliance with project and departmental goals and objectives.
• Identify, prioritize, and monitor quality issues to maintain compliance.
• Assist during PV audits, inspections, and CAPA processing.
• Support implementation of new technologies and solutions, as applicable.
• Report time and activities per SOPs and Line Manager requirements.
• Participate in internal initiatives and other activities as assigned by Line Manager.
• Perform other tasks as assigned by Line Manager or PV QM and other PV activities as requested.

Position Qualifications

Excellent knowledge of ICH GCP and other ICH/EMA/FDA and local PV regulations and standards. Ability to interact with other departments and be proficient in written and verbal communication. Proficient in Microsoft Excel, PowerPoint and Word and quick to learn new software.

Demonstrated proficiency in safety systems such as Oracle Argus Safety, ARISg or SafetyEasy. Ability to apply regulatory and compliance guidelines to content development.

Competency Statements

• Self-Motivated
• Attention to detail, teamwork, and initiative
• Organized
• Accuracy
• Technical Aptitude
• Tactful
• Responsible
• Problem Solving
• Active Listening
• Customer Oriented
• Communication, Written
• Communication, Oral
• Applied Learning

Education and Experience

Education: Advanced degree in pharmacy (PharmD preferred) or other life science degree, or relevant pharmacovigilance experience.

Experience: Minimum of three years related experience in pharmacovigilance; experience with drugs, medical devices, vaccines, and biologics preferred.

Computer Skills: Proficiency with Embase, Ovid Medline, PubMed, Microsoft Office, and safety databases such as Oracle Argus Safety, ArisG LifeSphere, Veeva Safety, AB Cube SafetyEasy and content management systems.

Other Requirements: Preferred pharmaceutical industry experience with understanding global regulatory, legal, and compliance requirements in pharmacovigilance.

Work Environment

Remote: Romania / Poland or Portugal

The company reserves the right to change this job description and assign tasks as needed. This document is not a contract of employment.

To apply for this role

Step 1: Follow the form instructions. Step 2: HR will review your application with feedback. Step 3: If successful, HR will arrange an introductory call. Step 4: Potential online language assessment. Step 5: 1st formal interview. Step 6: 2nd formal interview. Step 7: Offer.

NB: The Job Description will be provided at Step 3 along with further information. We are an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, national origin, age, disability, genetic information, or veteran status.

Recruitment Agency Notice: Recruitment agencies should avoid unsolicited CVs; in-house team manages all hiring processes. Unsolicited CVs or candidate profiles received without prior engagement will be considered with no obligation to Med Communications.