Specialist, Safety Operations

at  IAVI

POSITION DESCRIPTION

Job Title: Specialist, Safety Operations
Location: Cape Town, South Africa; Remote – South Africa; Nairobi, Kenya; Amsterdam, Netherlands; OR Remote – United Kingdom
Reports to: Executive Director, Drug Safety and Pharmacovigilance

POSITION SUMMARY:

Are you an experienced Drug Safety Professional, who is eager to apply it in a mission-driven setting focused on public heath?
IAVI is seeking a Specialist, Safety Operations who will execute operational and administrative activities within the drug safety & pharmacovigilance function, ensuring timely completion of reports for distribution to health authorities, partners, as well as internal and external stakeholders, ensuring alignment to safety reporting regulations and ICH/GCP guidelines. The Specialist works closely with the Executive Director, Drug Safety & Pharmacovigilance in maintaining the safety sections of eTMF, ensuring necessary blinding is maintained for the trial teams. The Specialist will support the Executive Director, DSPV ensuring adequate oversight of the Pharmacovigilance vendor, while ensuring good documentation practice is followed and adhered to, filing documentation for the department in the designated SharePoint site, and providing general administrative support for safety operations. The Specialist will also help develop, update, and implement governance and procedural documents in the Drug Safety & Pharmacovigilance unit, working closely w/ Quality Assurance.
Help IAVI translate science into global health solutions as a Specialist, Safety Operations!

EDUCATION AND EXPERIENCE:

• Bachelor’s degree, preferably within a scientific or related field is required.
• Minimum 3 years of industry experience is required.
• Experience working in drug safety operations is required.

QUALIFICATIONS AND SKILLS:

• Experience and understanding of PV operations and/or clinical trial operations related to safety reporting and research principles is required.
• Knowledge of and experience working with medical terminology and medical coding dictionaries (e.g. MedDRA) is required.
• Strong organizational skills, including the ability to work on multiple projects with overlapping schedules and flexibility, as well as to be able to change priorities to meet deadlines and organizational needs.
• Ability to work both independently and collaboratively in large, complex, cross-functional project teams.
• Attention to detail.
• Excellent verbal and written communication skills.
• Ability to complete tasks on time and with high quality.
• Critical thinking skills, with the ability to identify problems and possible solutions, and assess impact on timelines.
• Ability to work effectively with teams of diverse educational and cultural backgrounds and maintain a high standard of professional conduct as a representative of IAVI.
• Computer and technological literacy, proficiency in Microsoft Office Suite, and the ability to quickly learn and master new systems is required.
• Experience in electronic Trial Master File software such as Veeva or similar eTMF system is highly desirable.
• Experience in a Pharmaceutical/CRO environment is highly preferred.

IAVI CORE VALUES:

• Dedication to the Mission: We are committed to the translation of scientific discoveries into affordable, globally accessible public health solutions.
• Innovative Evolution: We are committed to solving complex problems in creative and innovative ways, learning from our mistakes and successes and never giving up
• Integrity: We are committed to meeting the highest ethical and professional standards in everything we do and to taking responsibility for our actions to earn respect
• Collaboration: We are committed to embracing diversity, the power of global teamwork and the belief that by working as one we can make a difference
  Disclaimer: Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities and skills required of personnel so classified. This document does not create an employment contract, implied or otherwise, other than an “at-will” relationship. IAVI is an equal opportunity employer and applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
  IAVI IS AN EQUAL OPPORTUNITY EMPLOYER actively committed to fostering a diverse and inclusive global organization. IAVI believes that diversity and inclusion among our teammates is critical, and we seek to recruit, develop and retain the most talented people from a representative candidate pool. At IAVI, we celebrate the spectrum of colleagues’ experiences and believe that dedication to our mission above all is essential to our success as a scientific global non-profit. IAVI upholds these principles through IAVI’s Global Diversity and Inclusion Committee.
  IAVI has zero tolerance for discrimination or harassment on the basis of race, color, ethnicity, caste, national origin, home language, ancestry, religion, marital or civil partnership status, age, physical or mental disability, HIV status and any other medical condition, genetic information, pregnancy, sexual orientation, gender identity or expression, and veteran status, in addition to any other status protected under the law in any of our locations worldwide.

• Provide administrative and logistical support (scheduling, distributing agendas, taking and distributing minutes/action items) for teleconferences, internal and external meetings, trainings, or other meetings.
• Support the Executive Director, Drug Safety and Pharmacovigilance with financial management of the PV vendor, including tracking, reviewing and processing invoices as needed, and loading contract requests in contract central.
• Support the Executive Director, Drug Safety and Pharmacovigilance to assure optimal PV operational plans (e.g. Safety Management Plan, SAE/AE Reconciliation Plans) and consistency with the PV vendor contract and scope of work as well as alignment of appendices in the PV operational plans for specific trials with clinical operations plans/activities.
• File all relevant unit documents in the dedicated SP folder and relevant essential documents in the safety sections of the e-TMF, including documents related to ICSR case processing and communication to protect the clinical team from accidental unblinding, performing quality control checks as necessary.
• Participate in review of draft CIOMS prepared by PV vendor against the source document (ICSR reporting form) for quality, consistency, and accuracy.
• Liaise with research sites directly or via clinical operations for any unresolved ICSR queries escalated by the PV vendor.
• Assist with the development of tracking tools for PV activities and perform daily entry into and maintenance of appropriate tracking systems.
• Oversee the maintenance of training records for project team members.
• Participate in on-call duties for specific projects to ensure 24-hr coverage for safety reporting.
• Assist with gathering regulatory intelligence in respect of safety reporting requirements in territories in which IAVI is conducting or planning to conduct or support clinical trials.
• Anticipate/identify potential areas of non-compliance, enter/write deviations (internal and external) in the QMS, implement corrective actions, and escalate where appropriate.
• Assist with the completion of monthly metrics /assessment of PV vendor key performance indicators.
• Support audits and inspections as required for assigned projects.
• Assist with review of regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures, and guidelines.
• Perform other duties as assigned by the Executive Director, Drug Safety & Pharmacovigilance.