Associate Director, Drug Safety Physician

Job Title: Associate Director, Drug Safety PhysicianLocation: Cape Town, South Africa; Remote - South AfricaReports to: Executive Director Drug Safety and Pharmacovigilance

Position Summary:

Are you an ambitious Pharmacovigilance Physician who is eager to make an impact in a mission-driven organization?

The Drug Safety Physician in collaboration with the Head of Pharmacovigilance, and PV Specialist will assist with daily drug safety operational activities. A unique opportunity at a 50% part-time allocation, the Physician will collaborate cross-functionally with clinical development, regulatory, biostatistics, and clinical operations while overseeing and the pharmacovigilance vendor. The Physician interacts with internal and external partners, stakeholders, investigators, as well as regulatory agencies on safety topics as necessary.

Help [Employer] translate science into global health solutions – learn more and apply below!

Key Responsibilities:

• Participating in the design and conduct of clinical trials to ensure that safety and efficacy data are collected and analyzed appropriately

• Collaborating with other functional units/departments within the company, such as clinical development, regulatory affairs, to ensure that safety and efficacy data are communicated effectively to internal and external stakeholders

• Contributing to the preparation of regulatory submissions and as necessary responding to questions from regulatory agencies regarding the safety of products in development

• Reviewing and approving, as necessary, safety sections of clinical trial protocols and contributing to safety sections of the clinical study report

• Identifying and assessing safety risks associated with investigational products, and making recommendations for managing or mitigating those risks

• Reviewing and analyzing adverse event reports, clinical trial data, and other safety information related to products being evaluated in clinical trials sponsored by [Employer] or situations where [Employer] has safety reporting obligations

• Provide medical review and completion of analysis of similar events, company causality assessment, and expectedness assessment including review of MedDRA coding for individual safety case reports (ICSRs)

• Contribute to signal detection and risk management for assigned projects.

• Contribute to development of aggregate reports, (DSURs), Investigator’s Brochure updates, Signal detection reports, Safety Management Plans as necessary

• Contribute to oversight of the Pharmacovigilance vendor by reviewing operational compliance reports and the PV unit Risk Register

• Attending monthly project meetings with the PV vendor and the various internal project teams

• Attending Independent Data Monitoring Committee (IDMC) and Global Safety Monitoring Board (GSMB) meetings as necessary

• Assist with ensuring compliance with the requirements of safety data exchange agreements or safety data exchange in clinical trial agreements

• Support the data management team, as necessary, with periodic reconciliation of the clinical and safety databases for assigned projects

• Approve documents requiring filing in the study specific TMF, as necessary

• Support the ED Drug Safety and Pharmacovigilance with continuous process improvement initiatives within the Drug Safety and PV unit.

Education and Experience:

· MD or equivalent required

· Minimum 5 years of experience in a clinical research role with at least 3 years in a drug safety role required

· Experience with HIV /infectious diseases or vaccine development preferred

· Experience with clinical trials in Africa preferred

Qualifications and Skills:

· Experience and understanding of safety operations, safety regulations and clinical research principles 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 is required and ability to meet timelines in a fast-paced environment.

· Excellent verbal and written communication skills are required.

· Critical thinking skills, with the ability to identify problems and possible solutions, and assess impact on timelines is required.

· Ability to work effectively with teams of diverse educational and cultural backgrounds and maintain a high standard of professional conduct as a representative of [Employer] is required.

· Computer and technological literacy, proficiency in Microsoft Office Suite, and ability to quickly learn and master new systems is required.

· Good knowledge and experience with Medical Dictionary for Regulatory (MedDRA) coding of medical concepts

Organizational Overview:

[Employer] is a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges including HIV and tuberculosis. Our mission is to translate scientific discoveries into affordable, globally accessible public health solutions. Through scientific and clinical research in Africa, India, Europe, and the U.S., [Employer] is pioneering the development of biomedical innovations designed for broad global access. We develop vaccines and antibodies in and for the developing world and seek to accelerate their introduction in low-income countries. [Employer] programs and partnerships are grounded in the regions of the world where the disease burden is the greatest, and our approach emphasizes sustainability. Our network of clinical research center partners in Africa and India helps strengthen in-country research capacity and supports the training and education of the next generation of scientists. The global impact of our science includes fundamental contributions to understanding the biology of HIV infection, which [Employer] and others are applying toward advancing vaccine science and immunology. [Employer] accelerates scientific discovery and development by fostering unique collaborations among academia, industry, local communities, governments, and funders to explore new and better ways to address public health threats that disproportionately affect people living in poverty. Our global reach, including a clinical research network in five countries in sub-Saharan Africa and in India, has allowed us to make fundamental contributions to understanding the epidemiology, transmission, virology, and immunology of HIV. This work played a key role in facilitating the design of promising HIV vaccine candidates, as well as the discovery of broadly neutralizing antibodies that are now being advanced as promising approaches for HIV prevention. Our integrated capabilities in vaccine and antibody discovery, development, and clinical research take advantage of bio-pharmaceutical industry expertise to accelerate the development and testing of prevention methods for HIV and other diseases. Through the Product Development Center, we support external researchers with technical and scientific expertise to accelerate the development of their own products.

[Employer] CORE VALUES:

• Commitment: We deliver on our mission, proactively transforming promises into tangible results
• Stewardship: We steward [Employer]'s resources responsibly to ensure [Employer]'s long-term success and global health impact
• Integrity: We uphold strong moral principles to maintain our credibility as a nonprofit scientific research organization
• Collaboration: We work as one [Employer] team and partner with others to deliver globally accessible, urgently needed, public health solutions

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. [Employer] 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.

[Employer] is an equal opportunity employer. It is [Employer]’s policy to provide equal opportunity without regard to race, citizenship, color, sex, gender identity or expression, age, height, weight, disability (including physical and mental conditions unrelated to job performance), religion, creed, caste, home language, ancestry, national origin, pregnancy, marital or partnership status, sexual orientation, status as a protected veteran, ethnicity, genetic information, predisposing genetic characteristic, status as a victim of domestic violence, stalking and sex offenses, HIV status, or any other status protected by applicable federal, state, or local laws.

Compensation And Benefits Information:

Salary is paid in local currency, and is commensurate and competitive with the local labor market.Please note, there may be some variation based on experience level. In addition, this position offers competitive benefits including: generous retirement savings plan employer contributions; competitive health, dental and vision insurance plans; competitive paid time off policy; potential for annual bonuses based on performance; and other benefits. More information can be found on [Employer]'s career page.

Equal Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThis employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review theKnow Your Rightsnotice from the Department of Labor.

Originally posted on [Employer]