DKT International Nigeria is in search of a highly motivated, dynamic, and results-oriented professional to fill the role of Pharmacovigilance & Regulatory Affairs Manager. The ideal candidate will establish, maintain, and supervise a comprehensive Pharmacovigilance (PV) system while spearheading all regulatory affairs initiatives for DKT Nigeria’s product portfolio. This position demands a proactive individual with exceptional leadership, analytical, and stakeholder engagement abilities, dedicated to fostering compliance, ensuring product safety, and advancing the organization’s strategic growth objectives.
This position ensures adherence to NAFDAC Good Pharmacovigilance Practice (GVP) standards and all applicable regulatory mandates, while overseeing product registration processes, lifecycle management, and the introduction of new products to uphold product safety, maintain quality standards, and drive organizational expansion.
Key duties encompass planning, organizing, and overseeing project timelines, ensuring alignment with organizational objectives and regulatory standards. Collaborating with cross-functional teams, the role involves delegating tasks, monitoring progress, and providing strategic guidance to enhance productivity and efficiency. Additionally, the position demands meticulous budget tracking, resource allocation, and risk management to mitigate potential setbacks. Regular performance evaluations, stakeholder reporting, and process improvements are integral to maintaining operational excellence and delivering measurable outcomes.
We oversee the Pharmacovigilance System to ensure compliance with regulatory standards and maintain robust safety monitoring. This role involves managing adverse event reporting, signal detection, and periodic safety update reports while collaborating with cross-functional teams to implement risk mitigation strategies. Additionally, we conduct regular audits and inspections to verify adherence to Good Pharmacovigilance Practices and global regulatory requirements, ensuring the integrity and reliability of our pharmacovigilance processes.
Develop, execute, and sustain a comprehensive pharmacovigilance (PV) system that complies with both national regulatory mandates—such as those stipulated by NAFDAC—and internationally recognized standards.
Responsible for systematically gathering, recording, and overseeing adverse drug reactions (ADRs) to maintain comprehensive documentation and ensure seamless management of safety data.
Responsible for supervising the management of the photovoltaic (PV) database, with a primary focus on maintaining high standards of data integrity, completeness, and traceability throughout all processes.
Act as the primary Pharmacovigilance Lead and Safety Officer, overseeing all product-related safety and pharmacovigilance activities.
As a Regulatory affair and Product Registration Specialist, you will be responsible for ensuring compliance with global regulatory standards, managing the submission and approval processes for product registrations, and maintaining up-to-date knowledge of evolving regulations. Your role will involve coordinating with cross-functional teams, preparing comprehensive regulatory documentation, and addressing inquiries from regulatory authorities. Additionally, you will liaise with internal stakeholders to facilitate timely approvals and mitigate risks associated with non-compliance. Strong attention to detail, analytical skills, and the ability to interpret complex regulatory requirements are essential for success in this position.
Spearhead the preparation, submission, and management of product registration, renewal, and variation applications in collaboration with regulatory bodies such as NAFDAC to ensure compliance and timely approval.
Prepare and submit regulatory dossiers in strict accordance with Common Technical Document (CTD) and electronic Common Technical Document (ECTD) standards.
Ensure the prompt approval of all products, including pharmaceuticals, medical devices, and related categories.
Monitor and manage regulatory timelines while identifying and resolving submission gaps in advance to ensure compliance.
We are seeking a skilled professional to lead our New Product Development (NPD) initiatives, driving innovation and ensuring the successful launch of cutting-edge products. The ideal candidate will oversee the entire lifecycle of product development, from initial concept and market research to prototyping, testing, and commercialization. Responsibilities include collaborating with cross-functional teams such as R&D, engineering, marketing, and supply chain to align product strategies with business objectives. Additionally, the role requires analyzing market trends, identifying opportunities, and managing project timelines and budgets to meet strategic milestones. Proficiency in project management methodologies, strong analytical skills, and a track record of delivering high-impact products are essential. A degree in a relevant field, such as engineering, business, or design, along with prior experience in product development or a related discipline, is required.
Offer strategic regulatory and safety guidance during the selection, evaluation, and introduction phases of new product development to ensure compliance and mitigate risk.
Conduct comprehensive regulatory due diligence to assess new products and facilitate market entry.
Verify that all compliance requirements have been fully satisfied before the product launch.
Provide assistance to cross-functional teams, including marketing, supply chain, and programs, throughout the product rollout process.
Develop, implement, and oversee standard operating procedures (SOPs) to ensure organizational compliance with regulatory requirements and internal policies. Conduct comprehensive training programs to enhance employee proficiency in operational protocols, safety standards, and compliance frameworks. Monitor adherence to established guidelines, identify gaps, and recommend corrective actions to mitigate risks and maintain operational integrity. Collaborate with cross-functional teams to refine procedures, streamline workflows, and ensure alignment with industry best practices and legal obligations. Maintain meticulous documentation of training records, compliance audits, and procedural updates to support continuous improvement and regulatory accountability.
Develop, assess, and revise standard operating procedures (SOPs) pertaining to pharmacovigilance and regulatory compliance to ensure alignment with current guidelines and best practices.
Ensure adherence to all internal policies and regulatory mandates across the entire organization.
Design and develop instructional programs focused on photovoltaic systems, regulatory compliance standards, and mandatory reporting obligations. Ensure these training initiatives are structured to enhance participant understanding and practical application of the specified topics.
Foster a culture of compliance by ensuring awareness and accountability are upheld throughout every department.
Responsible for overseeing safety reporting protocols and implementing comprehensive risk management strategies, this role ensures compliance with regulatory standards and organizational policies. Duties include identifying potential hazards, conducting thorough risk assessments, and developing mitigation plans to minimize workplace incidents. Additionally, the position requires maintaining accurate documentation of safety incidents, analyzing trends to identify systemic issues, and reporting findings to management for informed decision-making. Strong attention to detail, analytical skills, and familiarity with safety regulations are essential for success in this role.
Timely identification, evaluation, and reporting of safety cases must be conducted in strict adherence to regulatory deadlines.
Compile and transmit mandatory safety documentation, including Periodic Safety Update Reports (Pours) and Individual Case Safety Reports (ICS Rs), in accordance with established regulatory timelines.
Analyze potential product risks, evaluate their impact, and implement preventive measures to ensure safety and compliance.
To address critical safety concerns, escalate such issues promptly and propose effective measures to mitigate potential risks.
Serves as the primary conduit between the organization and regulatory bodies, facilitating seamless communication and collaboration. Responsible for proactively identifying and addressing regulatory requirements, ensuring full compliance with applicable laws and guidelines. Engages stakeholders across various sectors to foster transparent dialogue, align expectations, and mitigate potential risks. Leads initiatives to streamline regulatory processes, enhance reporting accuracy, and promote adherence to industry standards. Requires a minimum of five years of relevant experience in regulatory affairs or a closely related field, along with strong interpersonal and negotiation skills. Proficiency in interpreting complex regulations and translating them into actionable strategies is essential.
Act as the main liaison between the organization and regulatory bodies, as well as external stakeholders.
Develop and maintain effective collaborations with regulatory bodies, strategic partners, and healthcare professionals to ensure compliance and foster mutually beneficial initiatives.
Serve as the official delegate for the organization during regulatory inspections, engagements with governmental bodies, and participation in industry forums.
Furnish regulatory guidance to internal stakeholders to facilitate informed decision-making processes.
We are seeking a professional to oversee quality assurance, conduct comprehensive audits, and drive ongoing process improvements within the organization. The ideal candidate will ensure adherence to regulatory standards, identify areas for enhancement, and implement corrective actions to optimize operational efficiency. Responsibilities include performing detailed audits, maintaining compliance records, analyzing performance metrics, and fostering a culture of continuous improvement across all departments. A strong background in quality management systems, analytical skills, and a proactive approach to problem-solving are essential. Proficiency in audit methodologies and continuous improvement frameworks is required, along with the ability to collaborate effectively with cross-functional teams.
Ensure adherence to all relevant regulatory standards, including Good Pharmacovigilance Practice (GVP) and Good Manufacturing Practice (GMP), to maintain compliance and operational integrity.
Conduct internal audit activities and manage external regulatory inspection processes.
Analyze discrepancies and develop, as well as execute, corrective and preventive actions (CAPA) to address identified issues.
Enhance the efficiency, effectiveness, and compliance of photovoltaic (PV) and regulatory systems through ongoing refinement and innovation.
The position involves tracking and evaluating measurable metrics, known as Key Performance Indicators (KPIs), to assess team or individual productivity and progress toward strategic objectives. Regular monitoring and analysis of these indicators are essential for identifying trends, highlighting areas requiring improvement, and ensuring alignment with established performance targets. The role necessitates a systematic approach to data collection and interpretation to support informed decision-making and continuous operational enhancement.
Approved regulatory submissions are completed punctually and in accordance with established deadlines.
Ensure strict adherence to the established deadlines for submitting ADR (Adverse Drug Reaction) reports to maintain regulatory compliance and accuracy.
Handle a range of regulatory compliance issues or audit findings, ensuring adherence to applicable laws, standards, and internal policies while mitigating risks associated with non-compliance. Analyze findings to determine root causes, implement corrective actions, and track progress to resolution, maintaining detailed documentation for audits and regulatory reviews. Collaborate with cross-functional teams to address deficiencies, provide guidance on compliance requirements, and foster a culture of accountability and continuous improvement within the organization.
Effectiveness metrics for the pharmacovigilance system, including case reporting rates and the completeness of submitted reports, are evaluated to ensure compliance with regulatory standards.
Promptly renew product registrations to ensure compliance with regulatory requirements and maintain uninterrupted market access.
Training effectiveness and compliance adoption are critical components of organizational success, ensuring that educational initiatives not only meet performance standards but also align with regulatory requirements. These efforts involve assessing the impact of training programs on employee performance, identifying areas for improvement, and fostering a culture of adherence to company policies and industry regulations. By systematically evaluating training outcomes and reinforcing compliance protocols, organizations can mitigate risks, enhance operational efficiency, and maintain legal and ethical integrity in their operations.
Ensuring the accuracy of data, maintaining system integrity, and adhering to compliance standards are critical priorities for this role. The position requires meticulous attention to detail to safeguard data quality, rigorous adherence to regulatory requirements, and a proactive approach to preserving system reliability. Additionally, the role involves continuous monitoring to ensure that all processes and outputs meet established compliance benchmarks and organizational expectations.
Efficiently expediting the approval processes for new products and ensuring their successful market introduction are key responsibilities of this role.
Seeking a candidate with a Bachelor’s degree in a relevant field, complemented by a minimum of three years of hands-on experience in a comparable role. Proficiency in industry-specific tools and software is essential, along with a strong understanding of best practices and regulatory standards. Excellent analytical, problem-solving, and communication skills are required to effectively collaborate with cross-functional teams and drive project success. Familiarity with data analysis and reporting methodologies is a valued asset, as is the ability to adapt to evolving business needs and priorities.
A Doctor of Pharmacy (Pharma) degree is required, with a Bachelor’s degree in Pharmacy also acceptable.
A minimum of six to eight years of professional experience in pharmacovigilance and/or regulatory affairs is required.
With a minimum of three years of experience in a managerial or supervisory capacity, candidates should demonstrate proficiency in leading teams and overseeing operations effectively.
Demonstrates a comprehensive understanding of national regulatory frameworks, including NAFDAC regulations, with proven expertise in compliance and oversight.
Proficiency in utilizing safety databases and regulatory submission systems is required.
Proficiency in professional certification within pharmacovigilance or regulatory affairs would be considered a valuable asset.
Proficient in a variety of technical and soft skills, the ideal candidate will demonstrate strong analytical abilities, effective communication, and collaborative teamwork. Familiarity with industry-specific tools and methodologies is essential, along with the capacity to adapt to evolving technologies and processes. Problem-solving skills are crucial, as is the ability to manage multiple priorities while maintaining high standards of accuracy and efficiency. Experience in a related field is preferred, and the ability to work independently or as part of a team is required.
Possesses comprehensive expertise in drug safety protocols and compliance with regulatory standards, ensuring adherence to all applicable laws and guidelines throughout the process.
Attention to detail and a strong commitment to accuracy are essential for this role.
Proficient in analyzing complex scenarios and devising effective solutions through critical thinking and methodical approaches. Adept at identifying underlying issues, evaluating multiple perspectives, and implementing data-driven strategies to resolve challenges efficiently. Strong capability to interpret intricate information, synthesize insights, and translate findings into actionable outcomes. Requires meticulous attention to detail and the ability to navigate ambiguity with logical reasoning.
Strong interpersonal abilities and adeptness at managing relationships with stakeholders
Demonstrates strong capability in collaborating across departments while effectively balancing and prioritizing multiple tasks and projects. Exhibits adaptability in fast-paced environments where competing demands require clear organization and prioritization skills. Proven ability to align team efforts with broader organizational goals while maintaining focus on critical deadlines and deliverables.
Qualified and enthusiastic applicants are encouraged to submit their CVs to hr@dktnigeria.org, with the job title clearly indicated in the email subject line.
Qualifications
BA/BSc/HND
Experience Required
6 - 8 years
