DKT International Nigeria is in search of a proactive, dynamic, and results-oriented professional to fill the role of Pharmacovigilance & Regulatory Affairs Manager. The ideal candidate will oversee the development, implementation, and management of a comprehensive Pharmacovigilance (PV) system while spearheading all regulatory affairs activities pertaining to DKT Nigeria’s product portfolio. This position demands a forward-thinking individual with exceptional leadership, analytical, and stakeholder engagement capabilities, tasked with upholding compliance standards, safeguarding product safety, and contributing to the organization’s strategic growth initiatives.
This position oversees adherence to NAFDAC Good Pharmacovigilance Practice (GVP) and regulatory standards, while spearheading product registration, lifecycle oversight, and innovative product development initiatives. The role prioritizes product safety and quality while driving organizational expansion and ensuring compliance throughout all processes.
Oversee and execute a range of critical duties integral to the role’s success, ensuring alignment with organizational objectives through meticulous planning and proactive engagement. Develop and implement strategies that enhance operational efficiency while maintaining high standards of quality and compliance across all initiatives. Collaborate with cross-functional teams to drive project completion, resolve challenges, and foster an environment of continuous improvement. Monitor performance metrics, analyze data trends, and provide actionable insights to optimize outcomes and support evidence-based decision-making. Serve as a key liaison with stakeholders to facilitate transparent communication, align expectations, and cultivate mutually beneficial partnerships. Uphold accountability for deliverables while adhering to deadlines, budget constraints, and regulatory requirements, demonstrating a commitment to excellence in every endeavor.
We are seeking a dedicated professional to oversee the management of our pharmacovigilance system, ensuring compliance with global regulatory standards and fostering the safe use of medicinal products. The role involves monitoring adverse drug reactions, maintaining comprehensive safety databases, and preparing periodic reports for health authorities. Candidates must possess a degree in pharmacy, medicine, or a related field, along with relevant certification in pharmacovigilance. Proficiency in regulatory guidelines (e.g., ICH, EMA, FDA) and experience with pharmacovigilance software are essential. Strong analytical skills, meticulous attention to detail, and the ability to communicate effectively with stakeholders are required. The position demands a proactive approach to risk management and a commitment to continuous improvement in safety monitoring processes.
Develop, execute, and oversee a comprehensive pharmacovigilance (PV) system that adheres to national regulatory mandates, such as those set forth by NAFDAC, as well as internationally recognized standards.
Ensure the accurate collection, thorough documentation, and efficient management of adverse drug reactions (ADRs).
Responsible for supervising the management of the photovoltaic (PV) database while maintaining the accuracy, thoroughness, and traceability of all stored data.
As the Pharmacovigilance Lead / Safety Officer, you will oversee all product-related safety monitoring and compliance activities. Responsibilities include managing adverse event reporting, ensuring adherence to regulatory standards, and leading pharmacovigilance operations. The role requires expertise in pharmacovigilance systems, strong leadership, and meticulous attention to detail to maintain patient safety and regulatory compliance.
Responsible for overseeing regulatory compliance and managing product registration processes, ensuring adherence to applicable laws and guidelines throughout the product lifecycle. Duties include preparing and submitting regulatory documentation, coordinating with health authorities, and maintaining up-to-date knowledge of evolving regulations to facilitate timely approvals. Requires a strong understanding of global regulatory frameworks, meticulous attention to detail, and the ability to liaise effectively with cross-functional teams to support product launches and maintenance activities.
Spearhead the preparation, submission, and ongoing management of product registration, renewal, and variation applications in collaboration with regulatory bodies such as NAFDAC.
Prepare and file regulatory dossiers in strict accordance with CTD and ECTD specifications.
Facilitate the prompt authorization of all products within the pharmaceutical, medical device, and related categories.
Monitor regulatory deadlines diligently and identify potential submission deficiencies in advance to ensure timely compliance with evolving requirements.
We are seeking a skilled professional to lead the New Product Development (NPD) process, playing a pivotal role in driving innovation and ensuring successful product launches. This position requires a strategic thinker with a proven track record of transforming concepts into market-ready offerings. Responsibilities include conducting market research, collaborating with cross-functional teams, and overseeing the entire product lifecycle—from ideation to commercialization. Candidates must possess strong project management skills, a deep understanding of consumer needs, and the ability to navigate complex challenges while adhering to timelines and budgets. Ideal applicants will have experience in [industry-specific requirements, if applicable] and a passion for creating impactful, high-quality solutions that meet both business and customer objectives.
Offer expert guidance on regulatory compliance and safety considerations throughout the processes of product selection, evaluation, and market introduction.
Oversee regulatory due diligence efforts for new products and market entry initiatives.
Prior to the product launch, verify that all compliance requirements are satisfied.
Collaborate with various cross-functional teams, including marketing, supply chain, and programs, to facilitate seamless product rollouts.
Develop, implement, and maintain Standard Operating Procedures (SOPs) to ensure adherence to regulatory standards and organizational policies. Design and deliver comprehensive training programs to enhance employee competency and ensure compliance with industry regulations. Oversee compliance initiatives to mitigate risks, address audit findings, and foster a culture of regulatory adherence throughout the organization.
Develop, assess, and revise standard operating procedures (SOPs) pertaining to pharmacovigilance and regulatory compliance to ensure adherence to industry standards and organizational requirements.
Ensure adherence to all internal policies and regulatory mandates across the organization.
Design and create instructional programs focused on photovoltaic systems, adherence to regulatory standards, and fulfillment of reporting requirements.
Promote a culture of compliance and accountability throughout every department by ensuring adherence to regulations and policies.
Overseeing safety reporting and implementing robust risk management protocols are fundamental responsibilities within this role. This position entails the meticulous tracking and documentation of safety incidents, near-misses, and hazardous conditions to ensure compliance with regulatory standards. Additionally, the incumbent will analyze trends, identify potential risks, and develop proactive mitigation strategies to minimize workplace hazards. Collaboration with cross-functional teams is essential to foster a culture of safety awareness and ensure the seamless integration of risk management practices across all operational areas.
Promptly identify, evaluate, and document safety cases while adhering to established regulatory deadlines.
Compile and file safety documentation in accordance with regulatory mandates, including Periodic Safety Update Reports (Pours) and Individual Case Safety Reports (ICS Rs).
Identify, evaluate, and address potential risks associated with products to ensure safety, compliance, and overall quality throughout their lifecycle.
Critical safety concerns must be promptly escalated, and actionable recommendations for mitigating risks should be proposed.
The position involves serving as the primary point of contact for regulatory bodies and external stakeholders, facilitating seamless communication and collaboration. Key responsibilities include interpreting and applying regulatory requirements, ensuring compliance with applicable laws and guidelines, and addressing inquiries from authorities and partners. Additionally, the role entails managing stakeholder relationships, fostering strategic partnerships, and representing the organization in discussions with government agencies and industry groups. Strong interpersonal skills, regulatory knowledge, and the ability to navigate complex compliance frameworks are essential for success in this role.
Act as the main liaison between regulatory agencies and external stakeholders, facilitating communication and collaboration to ensure compliance and alignment with organizational objectives.
Build and maintain strategic relationships with regulatory bodies, external partners, and healthcare professionals to ensure compliance and foster collaborative initiatives.
During regulatory inspections, industry forums, and key meetings, serve as the primary organizational representative, ensuring clear communication and adherence to compliance standards.
Offer strategic regulatory counsel to internal stakeholders to facilitate informed decision-making processes.
We are seeking a dedicated professional to oversee quality assurance, conduct comprehensive audits, and drive continuous improvement initiatives. The ideal candidate will possess strong analytical skills and a keen eye for detail, ensuring adherence to regulatory standards and operational excellence. Key responsibilities include implementing robust quality management systems, performing thorough risk assessments, and identifying opportunities for process optimization. Additionally, the role requires collaboration with cross-functional teams to foster a culture of quality and innovation throughout the organization.
Guarantee adherence to relevant regulatory frameworks, including Good Pharmacovigilance Practice (GVP) and Good Manufacturing Practice (GMP).
Conduct internal audits and manage external regulatory inspections to ensure compliance and operational integrity. Oversee audit processes, facilitate inspections, and collaborate with stakeholders to address findings and implement corrective actions.
Conduct a thorough assessment to pinpoint deficiencies, then develop and execute corrective and preventive actions (CAPA) to address them effectively.
Deliver ongoing enhancements to photovoltaic (PV) and regulatory frameworks, systems, and operational outcomes.
Key performance benchmarks (KPIs) will be employed to evaluate the success of this role, measuring productivity, efficiency, and overall contribution to organizational objectives. These metrics provide clear insights into performance levels, ensuring alignment with strategic goals while identifying areas for improvement. Regular assessments will track progress against established targets, fostering accountability and continuous enhancement of operational standards.
Regulatory submissions must be reviewed and finalized in adherence to established deadlines to ensure timely approval.
The ability to consistently submit ADR (Adverse Drug Reaction) reports within the required regulatory timelines is essential to ensure compliance with established reporting standards.
Investigates and resolves any regulatory compliance issues or audit findings to ensure adherence to applicable laws and standards, promptly addressing discrepancies to mitigate potential risks and maintain organizational integrity.
Pharmacovigilance system performance will be evaluated based on key indicators such as case reporting rates and the thoroughness of data completeness.
Ensure timely renewal of all product registrations without exception.
We are seeking a professional to enhance training effectiveness and ensure widespread adoption of compliance measures across the organization. The role involves evaluating current training programs, identifying areas for improvement, and implementing strategies to boost engagement and retention. Additionally, the candidate will monitor compliance adoption, track progress, and provide actionable insights to leadership to support continuous improvement and regulatory alignment. Strong analytical skills, attention to detail, and the ability to collaborate with cross-functional teams are essential for success in this position.
Ensuring the integrity, accuracy, and regulatory adherence of data and systems represents a critical focus, alongside maintaining robust compliance standards throughout all operational processes.
Efficiently expedite the approval processes and ensure flawless execution of product launches to maintain competitive market positioning.
Seeking a candidate with a Bachelor’s degree in a relevant field, coupled with at least three years of hands-on experience in [specific industry/role]. Proficiency in [specific software/tools] is essential, along with strong analytical and problem-solving abilities. The ideal applicant will demonstrate excellent communication skills, both written and verbal, and the capacity to work collaboratively in a team-oriented environment. Prior experience in [specific task/industry requirement] is highly preferred, as is familiarity with [relevant regulations/standards].
A Doctor of Pharmacy (Pharma) degree or a Bachelor’s degree in Pharmacy is required.
Seeking a candidate with a minimum of six to eight years of hands-on experience in pharmacovigilance or regulatory affairs.
Accumulated three or more years of experience in a leadership or oversight capacity.
Possesses comprehensive understanding of national regulatory frameworks, including NAFDAC.
Individuals should possess practical familiarity with safety database platforms and regulatory submission frameworks, ensuring accurate and timely handling of pharmacovigilance data in compliance with applicable guidelines.
Professional certification in pharmacovigilance or regulatory affairs will be considered a valuable asset.
We are seeking a highly skilled professional with a strong background in [specific skills, e.g., project management, data analysis, etc.], along with expertise in [relevant tools, e.g., Excel, Python, etc.]. The ideal candidate must demonstrate exceptional analytical thinking, effective problem-solving abilities, and outstanding communication skills to collaborate with cross-functional teams. Proficiency in [specific industry knowledge, e.g., finance, healthcare, etc.] is essential, as is the ability to work independently while meeting tight deadlines. Additionally, experience in [specific tasks, e.g., process improvement, client relations, etc.] is preferred. This role requires a proactive mindset, adaptability to evolving priorities, and a commitment to delivering high-quality results.
Profound understanding and practical experience with pharmaceutical safety protocols and compliance mandates are essential for this role.
Attention to detail and a commitment to precision are essential for this role.
Analytical and problem-solving skills are essential for evaluating complex situations, identifying key issues, and developing effective solutions. These skills involve the ability to interpret data, assess risks, and make informed decisions under pressure. Employers value candidates who demonstrate logical reasoning and the capacity to break down intricate problems into manageable components. Strong problem-solving abilities enable individuals to innovate, adapt to challenges, and contribute to strategic planning within the organization.
Skilled in effectively engaging with stakeholders and maintaining clear, professional communication.
Proven capability to collaborate effectively across diverse teams and departments while adeptly balancing and prioritizing competing tasks and objectives.
Interested and eligible applicants are invited to submit their curriculum vitae to hr@dktnigeria.org, with the job title clearly stated in the email subject line.
Qualifications
BA/BSc/HND
Experience Required
6 - 8 years
