Phiture
Overview
Senior Pharmacovigilance Specialist - Remote
The Senior Pharmacovigilance Specialist is a professional with scientific, clinical, and therapeutic area expertise responsible for case management activities, expedited/non-expedited reporting activities, periodic reporting activities, risk management, signal detection and surveillance, ad-hoc reporting, and participation in safety meetings for drugs, biologics, devices, vaccines, cosmetics, and/or animal products, according to applicable Standard Operating Procedures (SOP), project specific supporting documents, ICH Good Clinical Practice (ICH GCP), Good Pharmacovigilance Practice (GVP) and all other applicable regulations and standards. Senior Pharmacovigilance Specialists tasks depend on the process/project/role assigned.
Position Summary
The Senior Pharmacovigilance Specialist is a professional with scientific, clinical, and therapeutic area expertise responsible for case management activities, expedited/non-expedited reporting activities, periodic reporting activities, risk management, signal detection and surveillance, ad-hoc reporting, and participation in safety meetings for drugs, biologics, devices, vaccines, cosmetics, and/or animal products, according to applicable SOP, ICH GCP, GVP and all other applicable regulations and standards.
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 relevant computerized systems (e.g., PV database): data entry, MedDRA/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).
Cooperate with the Medical Reviewer to collect all 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 and/or assist in preparation (writing, compilation) of expedited and periodic safety reports (including SUSAR, DSUR, Line listings, IND safety reports).
Assist in writing of aggregate safety reports (PSURs/PBRERs, ADCOs, PADERs, etc.), DSURs, risk management plans and signal detection reports.
Apply regulatory and compliance guidelines to ensure expedited and non-expedited submissions to the appropriate entities, and periodic report submissions.
Create and review ad-hoc reports from the safety system and tools.
Complete Quality Review of periodic reports, ad-hoc reports, and data retrieved from safety systems and tools.
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 TLs or PV Quality Manager supervision.
Ensure PV documents are filed according to SOPs and project requirements.
Communicate effectively with internal and external stakeholders and participate in team meetings.
Maintain and develop professional knowledge through training and self-learning; share PV knowledge with the PV team, other departments and Clients, promoting patient safety principles.
Act as a mentor and trainer for new PV employees (knowledge sharing, content quality checks, issue solving support).
Participate in staff training to ensure Med Communications International compliance with 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, products, disease state management, emerging therapies, and the competitive landscape.
Comply with all 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 of incoming data and Client information.
If required, take responsibility for PV Projects implementation and maintenance as Implementation Leader or Team Leader.
Coordinate PV activities to ensure timely and adequate workload distribution for assigned team, as applicable.
Contribute to overall compliance with project and departmental goals and objectives.
Identify, prioritize, and monitor quality issues to be resolved to maintain compliance.
Assist during PV audits, inspections and CAPA processing.
Support implementation and use of new technologies and solutions, as applicable.
Report time and activities performed according to SOPs and Line Manager requirements.
Participate in internal initiatives and additional activities as assigned by Line Manager.
Perform other activities/tasks as assigned by Line Manager/PV QM.
Other pharmacovigilance activities as requested.
Qualifications Excellent knowledge of ICH GCP and other ICH/EMA/FDA and local regulations and standards applicable for PV area.
Ability to interact with other departments within the company and be proficient in e-mail, written, and verbal communication.
Proficient in Microsoft Excel, PowerPoint and Word and quickly able 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.
Competencies
Self-Motivated
Attention to detail, teamwork, and initiative
Organized
Accuracy
Technical Aptitude
Tactful
Responsible
Problem Solving
Active Listening
Customer Oriented
Written Communication
Oral Communication
Applied Learning
Education and Experience Education:
Advanced degree in pharmacy (PharmD preferred), or other life science degree, or relevant, equivalent pharmacovigilance experience.
Experience:
Minimum of three years related experience. Demonstrated expertise in pharmacovigilance activities with drugs, medical devices, vaccines, and biologics preferred.
Computer Skills:
Proficiency with Embase, Ovid Medline, PubMed, Microsoft Office products, safety databases such as Oracle Argus Safety, ARISg LifeSphere, Veeva Safety, AB Cube SafetyEasy and content management systems.
Other Requirements:
Preferred pharmaceutical industry experience including an excellent understanding of global legal, regulatory, and compliance requirements with regards to pharmacovigilance.
Work Environment Remote: Romania / Poland or Portugal
Apply Process To apply for this role:
Follow the form instructions
HR will review your application with feedback
If successful, HR will arrange an introductory call
Potential online language assessment
First formal interview
Second formal interview
Offer
NB: The Job Description will be provided at Step 3 along with further information so that all aspects of the role are covered as much as possible.
Disclaimers and Notices Disclaimer: By attaching your CV/resume or completing an online application, you consent to collection, processing, use, transfer (including to other countries/jurisdictions), storage, and disclosure of your personal data as described in the company Privacy Policy. We are an equal opportunity employer and all qualified applicants will receive consideration for employment 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 as our in-house team manages all hiring processes. Unsolicited CVs will be considered free with no obligation on the part of the company.
Expiry Status: Open – no indication that the role is closed in the description.
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The Senior Pharmacovigilance Specialist is a professional with scientific, clinical, and therapeutic area expertise responsible for case management activities, expedited/non-expedited reporting activities, periodic reporting activities, risk management, signal detection and surveillance, ad-hoc reporting, and participation in safety meetings for drugs, biologics, devices, vaccines, cosmetics, and/or animal products, according to applicable Standard Operating Procedures (SOP), project specific supporting documents, ICH Good Clinical Practice (ICH GCP), Good Pharmacovigilance Practice (GVP) and all other applicable regulations and standards. Senior Pharmacovigilance Specialists tasks depend on the process/project/role assigned.
Position Summary
The Senior Pharmacovigilance Specialist is a professional with scientific, clinical, and therapeutic area expertise responsible for case management activities, expedited/non-expedited reporting activities, periodic reporting activities, risk management, signal detection and surveillance, ad-hoc reporting, and participation in safety meetings for drugs, biologics, devices, vaccines, cosmetics, and/or animal products, according to applicable SOP, ICH GCP, GVP and all other applicable regulations and standards.
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 relevant computerized systems (e.g., PV database): data entry, MedDRA/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).
Cooperate with the Medical Reviewer to collect all 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 and/or assist in preparation (writing, compilation) of expedited and periodic safety reports (including SUSAR, DSUR, Line listings, IND safety reports).
Assist in writing of aggregate safety reports (PSURs/PBRERs, ADCOs, PADERs, etc.), DSURs, risk management plans and signal detection reports.
Apply regulatory and compliance guidelines to ensure expedited and non-expedited submissions to the appropriate entities, and periodic report submissions.
Create and review ad-hoc reports from the safety system and tools.
Complete Quality Review of periodic reports, ad-hoc reports, and data retrieved from safety systems and tools.
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 TLs or PV Quality Manager supervision.
Ensure PV documents are filed according to SOPs and project requirements.
Communicate effectively with internal and external stakeholders and participate in team meetings.
Maintain and develop professional knowledge through training and self-learning; share PV knowledge with the PV team, other departments and Clients, promoting patient safety principles.
Act as a mentor and trainer for new PV employees (knowledge sharing, content quality checks, issue solving support).
Participate in staff training to ensure Med Communications International compliance with 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, products, disease state management, emerging therapies, and the competitive landscape.
Comply with all 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 of incoming data and Client information.
If required, take responsibility for PV Projects implementation and maintenance as Implementation Leader or Team Leader.
Coordinate PV activities to ensure timely and adequate workload distribution for assigned team, as applicable.
Contribute to overall compliance with project and departmental goals and objectives.
Identify, prioritize, and monitor quality issues to be resolved to maintain compliance.
Assist during PV audits, inspections and CAPA processing.
Support implementation and use of new technologies and solutions, as applicable.
Report time and activities performed according to SOPs and Line Manager requirements.
Participate in internal initiatives and additional activities as assigned by Line Manager.
Perform other activities/tasks as assigned by Line Manager/PV QM.
Other pharmacovigilance activities as requested.
Qualifications Excellent knowledge of ICH GCP and other ICH/EMA/FDA and local regulations and standards applicable for PV area.
Ability to interact with other departments within the company and be proficient in e-mail, written, and verbal communication.
Proficient in Microsoft Excel, PowerPoint and Word and quickly able 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.
Competencies
Self-Motivated
Attention to detail, teamwork, and initiative
Organized
Accuracy
Technical Aptitude
Tactful
Responsible
Problem Solving
Active Listening
Customer Oriented
Written Communication
Oral Communication
Applied Learning
Education and Experience Education:
Advanced degree in pharmacy (PharmD preferred), or other life science degree, or relevant, equivalent pharmacovigilance experience.
Experience:
Minimum of three years related experience. Demonstrated expertise in pharmacovigilance activities with drugs, medical devices, vaccines, and biologics preferred.
Computer Skills:
Proficiency with Embase, Ovid Medline, PubMed, Microsoft Office products, safety databases such as Oracle Argus Safety, ARISg LifeSphere, Veeva Safety, AB Cube SafetyEasy and content management systems.
Other Requirements:
Preferred pharmaceutical industry experience including an excellent understanding of global legal, regulatory, and compliance requirements with regards to pharmacovigilance.
Work Environment Remote: Romania / Poland or Portugal
Apply Process To apply for this role:
Follow the form instructions
HR will review your application with feedback
If successful, HR will arrange an introductory call
Potential online language assessment
First formal interview
Second formal interview
Offer
NB: The Job Description will be provided at Step 3 along with further information so that all aspects of the role are covered as much as possible.
Disclaimers and Notices Disclaimer: By attaching your CV/resume or completing an online application, you consent to collection, processing, use, transfer (including to other countries/jurisdictions), storage, and disclosure of your personal data as described in the company Privacy Policy. We are an equal opportunity employer and all qualified applicants will receive consideration for employment 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 as our in-house team manages all hiring processes. Unsolicited CVs will be considered free with no obligation on the part of the company.
Expiry Status: Open – no indication that the role is closed in the description.
#J-18808-Ljbffr