Senior Pharmacovigilance Specialist - Remote

Senior Pharmacovigilance Specialist Remote

POSITION SUMMARY

The Senior Pharmacovigilance Specialist is a professional with scientific clinical and therapeutic area expertise responsible for case management activities expedited/nonexpedited reporting activities periodic reporting activities risk management signal detection and surveillance adhoc 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.

ESSENTIAL FUNCTIONS

To perform this job successfully an individual must be able to perform each essential duty satisfactorily. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions.

Essential Functions Statement(s):

• 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 followup requirements for all case types received from multiple sources such as spontaneous clinical trial postauthorization safety studies scientific literature etc
• Monitors the Client email Inbox performs review analysis triage and filing of safety information within established timeframes
• Processes safety information in relevant computerized system (e.g. PV database): data entry MedDRA and WHODrug coding case narrative writing quality control reconciliation as per client specific requirements
• Ensures quality compliance and consistency of all steps of case processing activities (case management)
• Cooperates 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
• Contributes and/or assists in preparation (writing compilation) of expedited and periodic safety reports (including Suspected Unexpected Serious Adverse Reactions (SUSAR) DSUR Line listings IND safety reports)
• Assistance/writing of aggregate safety reports (PSURs/PBRERs ADCOs PADERs etc.) DSURs risk management plans and signal detection reports
• Knowledge of regulatory and compliance guidelines to ensure expedited and nonexpedited submissions to the
• appropriate entities
• Knowledge of regulatory and compliance guidelines to ensure periodic report submission to the appropriate entities
• Knowledge of regulatory and compliance guidelines to ensure risk management activities are completed and reported within regulatory determined timelines to the appropriate entities
• Create and review adhoc reports from the safety system and associated safety tools
• Completes Quality Review of periodic reports and adhoc reports
• Completes Quality Review of data retrieved from the safety system and associated safety tools
• Assisting as member of the safety management team in the determination of whether new safety information requires amendment to Clinical Trials documentation
• Develops PV documentation including: SOPs Work Instructions Safety Management Plans under TLs or PV Quality Manager(PV QM) supervision
• Ensures that all PV documents are filed according to SOPs and project requirements
• Effectively communicates with internal and external stakeholders participates in internal and external team meetings
• Maintains and develops professional knowledge by participating in internal/external trainings and by selflearning;
• Shares PV knowledge and expertise with PV team other departments and Clients actively promoting patient safety principles and awareness
• Acts as a mentor and trainer for new PV employees (shares knowledge performs content quality check provides support in issue solving)
• Participate in staff training and other measures to ensure Med Communications International compliance with Client quality guidelines and key performance metrics.
• Supports the role of the QPPV and interacts as required.
• Assists in collection verification and tracking of local and global safety reporting requirements
• Demonstrate ongoing scientific and business expertise relevant to therapeutic areas including 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(IL) or Team Leader(TL)
• Coordinates PV activities to ensure timely and adequate distribution of workload for assigned team as applicable
• Contributes to overall compliance with project and departmental goals and objectives
• Identifies prioritizes and monitors quality issues to be resolved to maintain compliance
• Assists during PV audits inspections and CAPA processing
• Supports implementation and use of new technologies and solutions as applicable
• Reports time and activities performed according to SOPs and Line Manager requirements
• Participates in internal initiatives and additional activities (as assigned by Line Manager)
• Performs other activities/tasks if assigned by Line Manager/PV QM
• Other pharmacovigilance activities as requested.

POSITION 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 email written and verbal communication.
Proficient in Microsoft Excel Power Point 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.

Competency Statements

• SelfMotivated Ability to be internally inspired to perform a task to the best of ones ability using his or her own drive or initiative.
• Above average attention to detail teamwork and initiative.
• Organized Possesses the trait of being well organized or following a systematic method of performing a task.
• Accuracy Ability to perform work accurately and thoroughly.
• Technical Aptitude Ability to comprehend complex technical topics and specialized information.
• Tactful Ability to show consideration for and maintain good relations with others.
• Responsible Ability to be held accountable or answerable for ones conduct.
• Problem Solving Ability to find a solution for or to deal proactively with workrelated problems.
• Active Listening Ability to actively attend to convey and understand the comments and questions of others.
• Customer Oriented Ability to take care of the clients needs while following company procedures.
• Communication Written Ability to communicate in writing clearly and concisely.
• Communication Oral Ability to communicate effectively with others using the spoken word.
• Applied Learning Ability to participate in needed learning activities in a way that makes the most of the learning experience.

SKILLS AND ABILITIES

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: Prefer 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

The company has reviewed this job description to ensure that essential functions and basic duties have been included. It is intended to provide guidelines for job expectations and the employees ability to perform the position described. It is not intended to be construed as an exhaustive list of all functions responsibilities skills and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate. This document does not represent a contract of employment and the company reserves the right to change this job description and/or assign tasks for the employee to perform as the company may deem appropriate.

To apply for this role:

Step 1: Proceed to follow the form instructions
Step 2: Our HR team will review your application with feedback
Step 3: If successful HR will arrange your Introductory call
Step 4: A potential online language assessment
Step 5: 1st formal interview
Step 6: 2nd formal interview
Step 7: Offer

NB* To be fully informed 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.

Disclaimer

By attaching your Curriculum Vitae (CV) resume and/or completing an online application you are consenting to the collection processing use transfer (including but not limited to other countries/jurisdictions) storage and disclosure of your personal data as described in the Med Communications Inc. Privacy Policy. Please read this policy carefully for more information on your rights regarding personal data protection.

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:

Thank you for your interest in working with Med Communications. We kindly ask that recruitment agencies avoid sending unsolicited CVs as our inhouse team manages all hiring processes.

Please be aware that any unsolicited CVs or candidate profiles received without prior engagement or agreement with our recruitment team will be considered free and carry no obligation on the part of Med Communications. We thank you for your compliance with our policy.

Should collaboration opportunities arise we will reach out to preferred partners proactively. Your understanding and cooperation are appreciated.

Remote Work :

No