Summary of The Position:

The Senior Pharmacovigilance Associate (sPVA) I, works under minimal supervision, and is responsible for the pharmacovigilance activities on project-level in accordance with applicable guidelines, regulations, and Standard Operating Procedures (SOPs) and is overseen and supported by the designated project Research Physician. The sPVA also functions in a supportive role to the Pharmacovigilance Manager and Associate Director, Pharmacovigilance or designee/s across the spectrum of departmental activities, performing diversified functions as required, in accordance with qualification competence. The purpose of the SPVA on departmental level is to provide training to and mentoring of PV Associates. The overall objective is to ensure that the Pharmacovigilance Department of FHI Clinical functions optimally and effectively to foster good quality safety data and safety surveillance per project in compliance with ICH Good Clinical Practices (GCP), SA GCP and local legal requirements, European, FDA and other international guidelines, as well as FHI Clinical (or sponsor, if applicable) SOPs.

Essential Functions:

Planning, start-up, maintenance, and close-out pharmacovigilance activities per project, assist with safety and medical monitoring, medical writing, data management activities and ad hoc administrative services as and when required for clinical projects awarded to FHI Clinical.

Communicate with team members regarding safety management and important safety aspects for and during trial conduct and the collaboration of services between departments and role players with regard to deliverables, timelines and adherence to relevant directives, guidelines, standards of medical ethics and legal requirements of accrediting bodies.

Perform or assist with trial-specific pharmacovigilance activities, including but not limited to:

• Communication with the Project Management Team and Investigation sites.
• Development of Safety Management Plans and related safety reporting forms.
• Coordinating the development of safety databases.
• Providing training on the electronic safety reporting system and safety databases.
• Serious adverse event (SAE) and/ other Reportable Adverse Event (RAE) receipt, safety triage, review, evaluation, querying, follow up and tracking.
• Ensuring appropriate safety reporting to investigational sites, regulatory authorities, and independent ethics committees.
• Determining, in consultation with the designated project Research Physician, the appropriate management and/or escalation of reported safety data in terms of trial endpoints, pause criteria and/or Safety Data committees such as DSMB, Protocol Safety Review Team (PSRT) Independent Data Monitoring Committee (IDMC) as applicable.
• Assisting as core member of the safety management team in the determination of whether new safety information requires amendment to Investigator’s Brochures (IB), Informed Consent Forms (ICF), Clinical Trial Plans (CTP) and/or other documentation.

Assist with data management activities, including but not limited to:

• Data entry and verification.
• Data validation and query management.
• Coding of data using standard coding dictionaries, where applicable.
• Quality control activities.
• SAE Reconciliation.
• Database lock activities

Once assigned to a particular trial the sPVA is to take responsibility for the management of the safety database for the trial.

Assist with the writing and review of appropriate sections of:

• Protocols.
• Clinical Study reports.
• Safety update reports.
• Publications.
• Other documents in accordance with contractual requirements.

Assist with maintaining Department systems in a validated state.

Diversified administrative and clerical support, ensuring required trial specific as well as departmental documents are obtained, saved, ordered, easily accessible and appropriately filed per applicable project requirements and procedural documents.

Assist with the maintenance, review, and update of departmental SOPs.

Participate in, assist or perform activities related to required training:

• Pro-active role in obtaining and sharing relevant industry safety information, updates and changes to guidelines and regulations.
• Participation in training sessions and workshops, including presenting reports from any conferences attended.
• Providing training for other safety team members or other departments as appropriate.

Fulfill a governance role by functioning in an assistive oversight capacity of safety team members:

• Support the Associate Director/ Pharmacovigilance Manager or designee in reviewing and ensuring safety team member as well as departmental performance and required compliance.
• Delegation of pharmacovigilance workload, in consultation with the Associate Director, Pharmacovigilance or designee, to assigned safety team member.
• Review compliance with processes, procedural documents, project-specific requirements, and regulatory and statutory requirements to identify non-compliance and escalation to the Associate Director/ Pharmacovigilance Manager or designee

Other duties as may be assigned from time to time.

Knowledge, Skills, and Abilities:

• Excellent organizational skills with the ability to manage competing priorities.
• Excellent judgment and decision-making skills. Focuses on solutions and problem resolution versus complaining or placing blame.
• Excellent time management skills.
• Excellent oral and written communication skills.
• Ability to communicate in English, effectively and accurately, both orally and in writing.
• Superb understanding of medical and scientific terminology, of the principles of clinical assessment of adverse drug events, of international regulations and of reporting requirements.
• Uncompromising attention to detail and the ability to think analytically.
• Ability to problem-solve
• Positive attitude and ability to interact diplomatically and professionally with internal and external customers in a global environment.
• Demonstrates the ability to mentor, coach, motivate or lead an individual or team.
• Capable of providing constructive feedback in a professional and respectful manner. Excellent computer skills and the ability to learn appropriate software, as necessary.
• Good knowledge of at least one relevant therapeutic area.
• Great medical writing skills.
• Excellent knowledge of all FHI Clinical SOPs, ICH GCP, SA GCP, and local legal requirements, European, FDA, and other relevant international guidelines applicable to clinical research.

Position Requirements

Education:

• Bachelors or higher graduate degree. A degree in a medical/science-related field is preferred.
• In lieu of a degree, an equivalent combination of diplomas, certifications, or relevant work experience is required.
• Licensed or certified health care training will be beneficial.

Preferred Job-related Experience:

• A minimum of three (3) years of experience as a PVA or in a clinical research setting is preferred.
• Broad experience as a PVA performing services on complex studies is preferred.
• A track record of excellence in terms of quality and delivery is preferred.
• A reputation of sustained performance and accomplishment is preferred.

Additional Eligibility Qualifications:

• Experienced in Microsoft Office (i.e., Word, Excel, PowerPoint, Outlook, SharePoint, Teams, etc.).
• Experience with an EDC or CTMS is preferred.
• Knowledge and experience in at least one safety database in front-end use and trial-specific configuration.
• In-depth knowledge and understanding of theory and practice of safety monitoring.
• Ability to compile concise high-quality safety manuals and procedural documents.
• Ability to assess knowledge gaps in peers and to find appropriate opportunities to enable colleagues to gain the required experience.
• Able to determine the most appropriate methods and procedures when given a new assignment and able to take a leadership role in implementing the safety monitoring aspects of a clinical trial.
• Able to review reports, regulatory documents and other trial-related documentation to ensure documents meet required standards

Physical Expectations:

• Typical office environment. Ability to sit and stand for extended periods of time. Ability to lift or move 5-15 lbs. or 2.26 – 6.8kg.

Travel Requirements:

• Expected travel time is 10% for this position

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned with or without notice.

FHI Clinical, Inc. and its subsidiary and affiliate companies provide equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, or service in the military.

This job posting summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.

FHI 360 is an equal opportunity and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable law.

Our values and commitments to safeguarding: FHI 360 is committed to preventing any type of abuse, exploitation and harassment in our work environments and programs, including sexual abuse, exploitation and harassment. FHI 360 takes steps to safeguard the welfare of everyone who engages with our organization and programs and requires that all personnel, including staff members and volunteers, share this commitment and sign our code of conduct. All offers of employment will be subject to appropriate screening checks, including reference, criminal record and terrorism finance checks. FHI 360 also participates in the Inter-Agency Misconduct Disclosure Scheme (MDS), facilitated by the Steering Committee for Humanitarian Response. In line with the MDS, we will request information from job applicants’ previous employers about any substantiated findings of sexual abuse, exploitation and/or harassment during the applicant’s tenure with previous employers. By applying, job applicants confirm their understanding of these recruitment procedures and consent to these screening checks.

FHI 360 will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws.

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