What Pharmacovigilance Jobs are in Kenya?
Showing 25 Pharmacovigilance jobs in Kenya
Senior Drug Safety Physician - Pharmacovigilance
Posted 17 days ago
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Job Description
Our client, a globally recognized leader in pharmaceutical innovation, is seeking a highly experienced Senior Drug Safety Physician to join their expanding pharmacovigilance team. This position is designed to be fully remote, offering a unique opportunity to contribute to global patient safety from your own dedicated workspace. The Senior Drug Safety Physician will play a critical role in monitoring the safety profiles of investigational and marketed pharmaceutical products, ensuring compliance with global regulatory requirements. This role involves in-depth medical assessment of adverse event reports, signal detection, risk management, and contributing to regulatory submissions. The ideal candidate possesses a strong clinical background, extensive experience in pharmacovigilance, and a meticulous approach to data analysis and medical interpretation. We are looking for a proactive and independent physician who can provide expert medical input and lead safety-related projects. This is a significant opportunity to make a substantial impact on patient safety and drug development within a highly respected organization, all within a flexible, remote working structure. The challenges in drug safety are ever-increasing, and this role is central to navigating them effectively.
Key Responsibilities- Provide medical expertise in the evaluation and assessment of adverse event reports from clinical trials and post-marketing sources.
- Lead and contribute to signal detection and risk assessment activities for assigned products.
- Author and review aggregate safety reports, including Periodic Benefit-Risk Evaluations (PBRERs) and Development Safety Update Reports (DSURs).
- Contribute medical input to the development and review of Investigator's Brochures (IBs), clinical trial protocols, and Clinical Study Reports (CSRs).
- Collaborate with regulatory affairs to ensure timely and accurate submissions of safety information to health authorities worldwide.
- Participate in cross-functional safety review meetings and contribute to risk management planning and implementation.
- Provide medical oversight for case processing activities and ensure the quality and accuracy of safety databases.
- Mentor and guide junior medical safety professionals and contribute to the development of departmental procedures and training materials.
- Stay current with global pharmacovigilance regulations, guidelines, and best practices.
- Serve as a key medical point of contact for internal stakeholders and external partners regarding product safety matters.
- Medical Doctor (MD or equivalent) degree with board certification in a relevant specialty (e.g., Internal Medicine, Cardiology, Neurology, Psychiatry).
- Minimum of 6 years of experience in drug safety and pharmacovigilance within the pharmaceutical industry.
- Strong understanding of clinical development processes and regulatory requirements for pharmacovigilance globally (e.g., FDA, EMA).
- Proven experience in medical assessment of adverse events, signal detection, and risk management.
- Excellent medical knowledge and ability to critically evaluate scientific literature.
- Exceptional analytical, problem-solving, and decision-making skills.
- Superior written and verbal communication skills, with the ability to clearly articulate complex medical and safety information.
- Demonstrated ability to work independently and manage multiple priorities effectively in a remote setting.
- Experience with safety databases and pharmacovigilance software.
- Ability to collaborate effectively with diverse, cross-functional teams.
Our client offers a highly competitive salary and bonus structure, along with a comprehensive benefits package including premium health, dental, and vision insurance, a generous retirement savings plan with company match, and substantial paid time off. This role is fully remote, offering maximum flexibility and work-life balance. We provide significant opportunities for professional development, including support for continuing medical education, conference attendance, and internal training programs. Employees have access to cutting-edge research and development projects, contributing to advancements in medicine. Career progression opportunities within the global pharmacovigilance department are excellent. The company fosters a culture of scientific excellence, collaboration, and employee well-being. Stock options may be considered for highly qualified candidates. We are committed to fostering a diverse and inclusive work environment where all employees feel valued and respected. This role provides the chance to work on impactful projects from anywhere in the world.
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Job Description
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Lead Pharmacovigilance Scientist - Drug Safety & AE Management
Posted 14 days ago
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Job Description
Our client is a prominent global pharmaceutical company seeking a highly motivated and experienced Lead Pharmacovigilance Scientist to enhance their drug safety operations. This critical, fully remote role involves overseeing the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. You will be instrumental in ensuring regulatory compliance and safeguarding patient health by meticulously managing adverse event (AE) data and contributing to safety signal detection. This position offers the unique opportunity to lead a vital function within the pharmaceutical sector from a remote work setup, collaborating with a world-class team dedicated to producing safer and more effective medicines. Your leadership and scientific expertise will directly influence the safety profile of our client's products globally. We are dedicated to maintaining the highest standards of drug safety and are looking for a candidate who shares this commitment.
Key Responsibilities- Lead and manage the pharmacovigilance activities for assigned products, ensuring compliance with global regulatory requirements and company policies.
- Oversee the accurate and timely processing, assessment, and reporting of adverse event data to regulatory authorities and internal stakeholders.
- Conduct comprehensive safety data review and signal detection activities, identifying potential safety issues and recommending appropriate actions.
- Contribute to the development and maintenance of aggregate safety reports, including Periodic Benefit-Risk Evaluation Reports (PBRERs) and Development Safety Update Reports (DSURs).
- Collaborate with cross-functional teams, including regulatory affairs, clinical development, and medical affairs, to address safety-related inquiries and issues.
- Develop and implement pharmacovigilance processes and procedures to ensure efficiency and compliance in a remote environment.
- Serve as a subject matter expert on pharmacovigilance regulations and best practices.
- Train and mentor junior pharmacovigilance scientists and staff, fostering a culture of continuous improvement.
- Participate in the preparation and review of safety sections for regulatory submissions and other relevant documents.
- Manage vendor relationships and oversight for outsourced pharmacovigilance activities as applicable.
- Advanced degree (MSc, PhD, PharmD, MD) in a relevant scientific discipline.
- Minimum of 7 years of experience in pharmacovigilance within the pharmaceutical or biotechnology industry.
- Extensive knowledge of global pharmacovigilance regulations (e.g., FDA, EMA, CIOMS) and guidelines.
- Proven experience in aggregate data analysis, signal detection, and risk management.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional written and verbal communication skills, with the ability to effectively communicate complex safety information.
- Demonstrated ability to lead projects and teams in a remote setting.
- Proficiency with pharmacovigilance databases and safety reporting systems.
- Ability to work independently, manage multiple priorities, and meet tight deadlines.
- Strong understanding of clinical trial processes and pharmaceutical development.
- Competitive salary package and performance-based bonuses.
- Comprehensive medical, dental, and life insurance coverage.
- Retirement savings plan with generous employer match.
- Generous vacation and sick leave policy.
- Opportunities for professional growth, training, and conference attendance.
- Home office setup allowance and reimbursement for work-related expenses.
- Flexible remote working arrangements.
- Access to cutting-edge pharmacovigilance tools and technologies.
- A collaborative and inclusive global team environment.
- The chance to contribute significantly to patient safety worldwide.
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Pharmacovigilance Specialist - Drug Safety Monitoring
Posted 19 days ago
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Job Description
Our client, a renowned pharmaceutical organization, is seeking a vigilant and experienced Pharmacovigilance Specialist to join their dedicated drug safety team. This role is entirely remote, providing an excellent opportunity for a qualified professional to contribute to the safety monitoring of pharmaceutical products globally from their home office. The Specialist will be responsible for the accurate and timely collection, assessment, and reporting of adverse event data. This position is critical in upholding patient safety and ensuring compliance with international regulatory standards. We foster a collaborative and supportive remote work environment focused on ethical drug safety practices.
Key Responsibilities- Collect, process, and assess adverse event (AE) reports from various sources, including spontaneous reports, literature, and clinical studies.
- Ensure accurate and timely entry of AE data into the pharmacovigilance database.
- Perform case narrative writing and regulatory reporting of safety information to health authorities as required.
- Collaborate with internal departments (e.g., Clinical, Medical Affairs, Regulatory) and external partners to obtain necessary safety information.
- Contribute to the preparation of Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs).
- Stay updated on global pharmacovigilance regulations and guidelines.
- Participate in signal detection activities and contribute to safety assessment.
- Assist in the development and review of pharmacovigilance procedures and training materials.
- Ensure compliance with company policies and regulatory requirements for pharmacovigilance.
- Maintain confidentiality and integrity of sensitive safety information.
- Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
- Minimum of 3 years of experience in pharmacovigilance or drug safety.
- Thorough understanding of pharmacovigilance principles, processes, and regulatory requirements (e.g., GVP, FDA regulations).
- Experience with safety databases (e.g., Argus, ArisG) is highly desirable.
- Strong analytical skills and meticulous attention to detail.
- Excellent written and verbal communication skills.
- Ability to work independently, manage workload effectively, and meet strict deadlines in a remote setting.
- Proficiency in medical terminology and case processing.
- Good organizational skills and ability to prioritize tasks.
- Must have a dedicated home office with a stable, high-speed internet connection.
Our client offers a competitive salary and a comprehensive benefits package, including health, dental, and vision insurance. A robust retirement savings plan with employer matching is provided. Generous paid time off, encompassing vacation, sick leave, and public holidays, is offered. Opportunities for professional development, including specialized training and certifications, are encouraged. Join a forward-thinking pharmaceutical company committed to patient safety and offering the flexibility of a remote work arrangement.
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Job Description
- Supervise and coordinate the daily activities of solar PV installation crews.
- Ensure all installations are performed safely, efficiently, and in accordance with company standards, electrical codes, and manufacturer guidelines.
- Conduct site inspections before, during, and after installation to ensure quality and adherence to design plans.
- Manage installation schedules, materials, and equipment to ensure timely project completion.
- Provide technical guidance and support to installation teams, troubleshooting issues as they arise.
- Maintain accurate installation records, including daily logs, progress reports, and material usage.
- Communicate effectively with clients, addressing any questions or concerns during the installation process.
- Ensure compliance with all safety regulations and conduct regular safety briefings for crews.
- Train and mentor junior installation staff.
- Liaise with project managers and sales teams to ensure seamless project execution.
- Proven experience in solar PV installations, with at least 3 years in a supervisory or lead role.
- Strong understanding of solar PV system components, electrical wiring, and installation best practices.
- Knowledge of local building codes and electrical safety regulations.
- Excellent leadership, communication, and problem-solving skills.
- Ability to read and interpret blueprints, schematics, and installation manuals.
- Experience with various mounting systems and inverter technologies.
- Must possess a valid driver's license and have a clean driving record.
- Ability to work effectively in a team environment and manage multiple projects simultaneously.
- Certification from a recognized solar training program is highly desirable.
- Must be physically fit and able to work at heights and in various weather conditions.
- Competitive hourly wage and potential for overtime pay.
- Company vehicle provided for work-related travel.
- Health, dental, and vision insurance options.
- Paid training and opportunities for professional development and certifications.
- Generous paid time off and holiday schedule.
- Opportunity to work with a growing renewable energy company.
- Team-building events and a positive work culture.
- Tools and safety equipment provided.
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Pharmacovigilance Specialist - Drug Safety - Remote First
Posted 19 days ago
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Job Description
- Receive, assess, and process adverse event reports from various sources (e.g., healthcare professionals, patients, clinical trials).
- Ensure accurate and timely data entry of adverse event information into the safety database.
- Perform medical coding of adverse events and related terms using standard dictionaries (e.g., MedDRA).
- Generate and submit regulatory safety reports (e.g., CIOMS, P2R) to health authorities and ethics committees in compliance with global timelines.
- Monitor literature for potential safety signals and new information related to company products.
- Collaborate with internal teams (e.g., Clinical Operations, Regulatory Affairs, Medical Affairs) and external partners to gather necessary information for case assessment.
- Participate in the development and maintenance of pharmacovigilance procedures and training materials.
- Contribute to signal detection activities and risk management plans.
- Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
- Minimum of 3 years of experience in pharmacovigilance or drug safety, with hands-on experience in case processing.
- Proficiency in safety database systems and MedDRA coding.
- Solid understanding of global pharmacovigilance regulations (e.g., FDA, EMA, ICH guidelines).
- Excellent analytical, problem-solving, and organizational skills.
- Strong written and verbal communication skills.
- Ability to work independently, manage multiple priorities, and meet strict deadlines in a fully remote environment.
- Commitment to patient safety and data integrity.
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Remote Pharmacovigilance Scientist
Posted 12 days ago
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Job Description
Our client is a global biopharmaceutical company dedicated to ensuring the safety and efficacy of its medicines. We are looking for a vigilant and analytical Remote Pharmacovigilance Scientist to join our safety surveillance team. This is a fully remote position, allowing you to work from anywhere in Kenya and contribute to the critical task of monitoring and evaluating drug safety. You will be responsible for detecting, assessing, and preventing adverse drug reactions, ensuring patient safety remains paramount throughout the product lifecycle. Your expertise will be vital in maintaining regulatory compliance and safeguarding public health.
Key Responsibilities- Collect, process, and evaluate adverse event reports from various sources (e.g., healthcare professionals, patients, clinical trials).
- Perform case causality assessments and determine the seriousness and expectedness of adverse events.
- Contribute to the preparation and submission of safety reports to regulatory authorities (e.g., Periodic Safety Update Reports - PSURs, Development Safety Update Reports - DSURs).
- Monitor and analyze safety data to identify potential safety signals and trends.
- Participate in risk management planning and the development of risk mitigation strategies.
- Collaborate with clinical operations, medical affairs, and regulatory teams on safety-related matters.
- Ensure compliance with global pharmacovigilance regulations and company policies.
- Maintain accurate and organized safety databases and documentation.
- Assist in the preparation of safety sections for regulatory submissions and Investigator Brochures.
- Stay current with pharmacovigilance best practices, guidelines, and emerging safety issues.
- Bachelor's degree in Pharmacy, Nursing, Medicine, Life Sciences, or a related healthcare field.
- Minimum of 3 years of experience in pharmacovigilance or drug safety.
- Strong understanding of pharmacovigilance principles, methodologies, and regulatory requirements (e.g., ICH E2B, E2C).
- Experience with safety databases and case processing software.
- Excellent analytical skills and the ability to interpret complex safety data.
- Detail-oriented with strong organizational and documentation skills.
- Ability to work independently and manage workload effectively in a remote setting.
- Effective written and verbal communication skills, with the ability to communicate safety information clearly.
- Proficiency in English is essential; knowledge of other languages is a plus.
- Experience in signal detection and risk management is highly desirable.
This fully remote role offers the flexibility to work from home while contributing to vital patient safety initiatives. Our client provides a competitive salary, comprehensive benefits package, and opportunities for professional development in the field of drug safety. You will be an integral part of a global team dedicated to ensuring the safe use of medicines, working remotely from your chosen location within Kenya .
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