DKT International Nigeria is currently recruiting for the position of Pharmacovigilance & Regulatory Affairs Manager, seeking a highly motivated, proactive, and outcome-focused professional to lead this critical function. The selected candidate will be tasked with developing, implementing, and supervising a comprehensive Pharmacovigilance (PV) framework while spearheading all regulatory affairs initiatives across DKT Nigeria’s product portfolio. This role demands a strategic leader with exceptional analytical capabilities, strong stakeholder engagement expertise, and the ability to uphold compliance standards, safeguard product safety, and contribute to the organization’s expansion goals.
This position oversees adherence to NAFDAC Good Pharmacovigilance Practice (GVP) and all relevant regulatory standards, spearheading product registration processes, lifecycle oversight, and the introduction of new products to uphold safety, maintain quality, and drive organizational expansion.
Oversee a comprehensive range of critical duties, including but not limited to strategic planning, team leadership, and operational execution to drive organizational success. Develop and implement policies that enhance efficiency and compliance with industry standards while fostering a culture of innovation and accountability. Collaborate cross-functionally to align business objectives with departmental goals, ensuring seamless integration of initiatives. Monitor performance metrics to identify trends, mitigate risks, and optimize resource allocation for sustained growth. Maintain strong stakeholder relationships through transparent communication and proactive problem-solving.
We oversee the continuous enhancement and operational efficiency of the pharmacovigilance system to ensure compliance with regulatory standards and optimal performance. This role involves maintaining and improving the system’s functionality, integrating updates, and verifying that all processes align with current guidelines. Additionally, we manage system documentation, conduct regular audits, and address any deviations to uphold the integrity and reliability of pharmacovigilance activities.
Establish, implement, and continuously maintain a comprehensive pharmacovigilance (PV) system that fully complies with national regulatory mandates, including those set by NAFDAC, as well as internationally recognized standards.
We are responsible for meticulously collecting, accurately documenting, and efficiently managing adverse drug reactions (ADRs) to ensure comprehensive pharmacovigilance and regulatory compliance.
Responsible for the administration of the photovoltaic (PV) database, maintaining rigorous standards for data accuracy, comprehensiveness, and traceability to support reliable reporting and decision-making processes.
Provide leadership and oversight as the Pharmacovigilance Lead / Safety Officer, responsible for all products.
Regulatory Affairs & Product Registration professionals ensure compliance with global regulatory standards while managing product registrations. They oversee the preparation, submission, and maintenance of regulatory documentation, liaising with health authorities to obtain necessary approvals. Responsibilities include monitoring regulatory changes, conducting gap analyses, and advising cross-functional teams on compliance requirements. Strong attention to detail, analytical skills, and expertise in regulatory frameworks are essential, alongside proficiency in relevant software tools. Experience in the pharmaceutical, biotechnology, or medical device industries is typically required, with a preference for candidates holding a degree in a scientific or regulatory discipline.
Spearhead the preparation, submission, and management of product registration, renewal, and variation applications with regulatory bodies, including NAFDAC, ensuring full compliance with established guidelines and timelines.
Prepare and file regulatory dossiers in compliance with CTD/ECTD specifications, ensuring adherence to all submission standards and timelines.
Ensure all products, including pharmaceuticals, medical devices, and related categories, receive timely approvals.
Monitor regulatory timelines vigilantly and identify submission gaps in advance to ensure timely compliance and mitigate potential risks.
New Product Development (NPD) involves the systematic process of conceiving, designing, and launching innovative products to meet market demands. This role requires a strong background in product lifecycle management, market research, and cross-functional collaboration to ensure successful product launches. Key responsibilities include identifying customer needs, conducting feasibility studies, and overseeing prototyping and testing phases. Candidates should possess a degree in engineering, business, or a related field, along with experience in project management and proficiency in industry-standard software tools.
Offer expert guidance on regulatory compliance and safety considerations during the assessment, selection, and launch phases of new product initiatives.
Conduct regulatory due diligence for the introduction of new products and expansion into new markets.
Before proceeding with the product launch, verify that all compliance requirements have been fully satisfied.
Collaborate seamlessly with cross-functional teams—including marketing, supply chain, and programs—to facilitate successful product rollout initiatives.
We are responsible for developing, implementing, and maintaining Standard Operating Procedures (SOPs), ensuring adherence to regulatory compliance standards, and delivering comprehensive training programs. This role entails establishing robust frameworks to govern operational consistency, conducting thorough audits to verify compliance with internal policies and external regulations, and designing and executing training initiatives to enhance employee competency and performance. Additionally, we monitor ongoing compliance metrics, address deviations promptly, and continuously improve processes to align with evolving industry requirements and organizational objectives.
Develop, assess, and revise standard operating procedures (SOPs) governing pharmacovigilance and regulatory operations.
Ensure adherence to all internal policies and regulatory standards across the entire organization.
Design and develop comprehensive training programs focusing on photovoltaic (PV) systems, regulatory compliance standards, and mandatory reporting requirements. Ensure these programs effectively communicate complex technical and legal concepts to diverse audiences, equipping participants with the necessary knowledge and skills to meet industry obligations.
Promote adherence to compliance standards by fostering awareness and accountability throughout every department.
Safety Reporting and Risk Management professionals are responsible for identifying, assessing, and mitigating potential hazards to ensure workplace safety and compliance with regulatory standards. They develop and implement safety protocols, conduct risk assessments, and maintain accurate records of incidents and near-misses. Additionally, they provide training to employees on safety procedures and emergency response, ensuring a proactive approach to risk prevention. Strong analytical skills, attention to detail, and familiarity with OSHA or other relevant safety regulations are essential requirements for this role.
Timely identification, evaluation, and documentation of safety cases must be conducted in strict adherence to regulatory deadlines.
Develop and file regulatory safety documentation, including Periodic Safety Update Reports (Pours) and Individual Case Safety Reports (ICS Rs), in accordance with applicable guidelines and timelines.
Conduct thorough evaluations to pinpoint potential risks associated with the product, analyze their impact, and implement effective measures to mitigate those risks.
Report critical safety concerns promptly and propose measures to mitigate potential risks.
The position involves serving as the primary regulatory liaison and fostering strong stakeholder relationships to ensure alignment with industry standards and organizational objectives. Responsibilities include interpreting and communicating regulatory requirements, addressing compliance concerns, and advocating for the organization’s interests in interactions with governing bodies. Additionally, the role entails building and maintaining collaborative partnerships with key stakeholders to facilitate transparent communication and promote mutual understanding. The ideal candidate will possess a strong background in regulatory affairs or a related field, along with exceptional interpersonal and negotiation skills to effectively manage diverse interests and drive consensus.
Act as the main liaison between the organization and regulatory bodies as well as external stakeholders.
Foster and maintain strategic alliances with regulatory bodies, collaborative partners, and healthcare professionals to ensure compliance and operational alignment.
Serve as the official organizational delegate in regulatory audits, industry conferences, and compliance forums, ensuring adherence to standards and fostering stakeholder engagement.
Deliver expert regulatory guidance to internal stakeholders to inform and support their decision-making processes.
We are seeking a meticulous professional to oversee quality standards, conduct comprehensive audits, and drive continuous improvement initiatives within our organization. The ideal candidate will ensure adherence to regulatory requirements, industry best practices, and internal policies while identifying opportunities to enhance efficiency, reduce waste, and elevate product and service excellence. Responsibilities include performing systematic audits, analyzing performance data, implementing corrective and preventive actions, and fostering a culture of accountability and innovation. Proficiency in quality management systems, strong analytical skills, and the ability to collaborate across departments are essential. Experience in a similar role within a regulated environment is preferred.
Ensure adherence to relevant regulatory frameworks, including Good Pharmacovigilance Practice (GVP) and Good Manufacturing Practice (GMP), to maintain operational integrity and meet industry standards.
Conduct internal audits and facilitate external regulatory inspections.
Examine discrepancies within processes and systems, then develop and execute corrective and preventive measures to address identified issues and mitigate potential risks.
Promote ongoing enhancements across photovoltaic (PV) and regulatory frameworks, systems, and operational outcomes to ensure sustained excellence and compliance.
The position entails monitoring and evaluating progress through quantifiable metrics known as Key Performance Indicators (KPIs), which serve as benchmarks for assessing organizational success and operational efficiency. These indicators are critical in measuring performance against predetermined targets, enabling data-driven decision-making and strategic adjustments to enhance productivity and outcomes. Regular analysis of KPIs ensures alignment with business objectives while identifying areas for improvement, fostering continuous growth and accountability within the team or department.
Regulatory submissions are finalized and approved in accordance with established deadlines.
ADR reporting timelines must be adhered to strictly to ensure compliance.
Handle a variety of regulatory compliance challenges and audit discrepancies with precision and thoroughness. Identify, document, and resolve issues efficiently to uphold organizational standards and mitigate potential risks. Ensure adherence to applicable laws, regulations, and internal policies while maintaining accurate records and supporting evidence. Collaborate with cross-functional teams to implement corrective actions and prevent recurrence of identified problems.
Pharmacovigilance system effectiveness is assessed through metrics such as the rate of case reporting and the thoroughness of case documentation.
Ensure that all product registrations are renewed punctually to maintain compliance with regulatory standards and operational continuity.
Effectiveness of training programs and adherence to compliance standards represent critical focal points within this role. Responsibility encompasses evaluating the impact of learning initiatives while ensuring full alignment with regulatory and organizational requirements.
Ensuring high standards of data accuracy, maintaining robust system integrity, and adhering to strict compliance protocols are essential priorities for this role.
Accelerating the pace of new product approvals and ensuring successful launches are central to this role. The position demands meticulous oversight of the entire approval process, from submission to final clearance, while simultaneously driving strategies that guarantee market-ready product deployment. Success hinges on balancing regulatory compliance with operational efficiency, all while meeting aggressive launch deadlines without compromising quality or safety.
Seeking a candidate with a Bachelor’s degree in a related field and a minimum of three years of hands-on experience in a comparable role. Proficiency in industry-standard software and 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. Familiarity with project management methodologies and prior leadership experience are highly advantageous.
A Doctor of Pharmacy (Pharma) degree is strongly preferred, with a Bachelor’s degree in Pharmacy also considered acceptable.
A minimum of six to eight years of professional experience in pharmacovigilance or regulatory affairs is required.
With a minimum of three years of experience in a managerial or supervisory capacity, candidates should demonstrate a proven track record in leadership and team oversight.
Proficiency in national regulatory frameworks, including NAFDAC guidelines, is essential for this role.
Proficiency in utilizing safety databases and regulatory submission systems is essential for this role. Candidates should possess hands-on experience with these specialized tools to ensure compliance and efficient data management. A strong understanding of regulatory frameworks and the ability to navigate submission processes are also required.
Professional certification in pharmacovigilance or regulatory affairs would be considered a valuable asset.
Proven expertise in relevant technical or functional areas, combined with strong problem-solving abilities and attention to detail, is essential. Demonstrated leadership in driving initiatives, fostering collaboration, and adapting to evolving business needs is required. Excellent communication skills, both written and verbal, are necessary to articulate complex ideas clearly and influence stakeholders at all levels. A track record of delivering measurable results within specified timelines is expected, along with a commitment to continuous learning and professional development. Proficiency in industry-standard tools and methodologies, as well as the ability to analyze data to inform strategic decisions, are critical. Candidates must exhibit a proactive mindset, resilience under pressure, and a dedication to upholding high ethical standards in all professional interactions.
Possesses comprehensive expertise in pharmacovigilance principles and compliance with regulatory frameworks, ensuring strict adherence to safety standards and legal obligations.
Attention to detail and a strong commitment to accuracy are essential for success in this role.
Demonstrates strong analytical and problem-solving abilities, leveraging critical thinking to evaluate complex situations and develop effective solutions. Applies structured methodologies to dissect challenges, identify root causes, and implement data-driven decisions that drive operational improvements and strategic outcomes.
Strong interpersonal abilities and adept stakeholder engagement are essential for this role.
Ability to work cross-functionally and manage multiple priorities
Interested and qualified candidates should forward their CV to: hr@dktnigeria.org using the position as subject of email.
Qualifications
BA/BSc/HND
Experience Required
6 - 8 years
