Impacting Lives Through Achieving Excellence: The Approach of Dr. Reem Yasin in Pharmacovigilance and Quality Management System (QMS)  

Dr. Reem Yasin
Dr. Reem Yasin

Meet Dr. Reem Yasin, the Head of Quality Assurance and Pharmacovigilance at Hawkary Pharmaceuticals Co., one of Iraq’s premier pharmaceutical companies. With a background in pharmacy, Dr. Reem graduated from the University of Jordan and later lectured at the College of Pharmacy there.

Her professional journey spans over a decade and encompasses extensive experience in Integrated Quality Management, legal agreements, and Pharmacovigilance in Jordan, Iraq, the GCC, and Europe.

Dr. Reem’s journey into the pharmacy and quality assurance sectors was inspired by a combination of personal interests, academic pursuits, and professional experiences. Dr. Reem’s fascination with the intersection of science and healthcare began at a young age, driven by a keen observation of how medications not only treat illnesses but also enhance people’s well-being and quality of life.

This early curiosity prompted her to pursue a pharmacy degree, immersing herself in pharmaceutical sciences and recognizing the pivotal role pharmacists play in promoting well-being.

As her academic journey progressed, Dr. Reem found herself increasingly drawn to quality management within the pharmaceutical industry. She was impressed by the critical responsibility of ensuring the safety, effectiveness, and quality of medications. The notion of contributing to public health by safeguarding processes resonated deeply with her, motivating her to pursue a career in pharmacy and quality assurance.

Dr. Reem is deeply committed to excellence and continual improvement, aligning with her core values and professional goals. She finds the evolving nature of the pharmaceutical industry, driven by advancements, research breakthroughs, and regulatory changes, to be exhilarating. This dynamic environment offers abundant learning opportunities, avenues for growth, and possibilities for innovation that inspire her.

At the heart of Dr. Reem’s professional journey lies a dedication to positively impact people’s lives through her work in pharmacy and quality assurance. She is driven by the opportunity to leverage her skills, expertise, and passion to uphold global quality standards while ensuring the safety and well-being of patients worldwide.

Safeguarding Patient Health

As the head of Quality Assurance and Pharmacovigilance at Hawkary Pharmaceuticals Co., Dr. Reem plays a pivotal role in creating and implementing a strong quality management system (QMS) that aligns with industry guidelines and standards. This involves establishing procedures for quality assurance across various areas such as manufacturing, testing, packaging, and distribution.

Regular audits and inspections are conducted under her supervision to identify areas for improvement and ensure compliance with quality standards. Dr. Reem also oversees internal audits and coordinates corrective measures when necessary to address any deficiencies.

Managing the pharmacovigilance program is another key responsibility for Dr. Reem. This entails monitoring the safety of products by collecting, evaluating, and reporting adverse events in accordance with pharmacovigilance regulations. Collaboration with cross-functional teams enables her to assess risks effectively and devise strategies to mitigate them, thereby enhancing product safety.

In addition to regulatory compliance, Dr. Reem prioritizes staff training programs to ensure that employees understand their roles in maintaining quality standards and managing pharmacovigilance effectively. These training sessions cover a range of topics including Good Distribution Practices (GDP), ISO QMS, and other relevant rules and guidelines to equip the team with necessary knowledge and skills.

Dr. Reem takes the lead in spearheading initiatives for continuous improvement aimed at enhancing the efficiency of the organization’s quality systems and pharmacovigilance processes. By fostering a culture of innovation and excellence, she strives to elevate the overall quality performance of Hawkary Pharmaceuticals Co.

Comprehensive Strategy for Pharmaceutical Products

With her extensive experience in quality management systems and pharmacovigilance, Dr. Reem ensures the quality and safety of products through a comprehensive strategy that incorporates various approaches and methods:

  • Setting up Strong Quality Management Systems (QMS): Dr. Reem focuses on creating and implementing QMS tailored to the organization’s specific needs. This includes developing standard operating procedures (SOPs), quality policies, and processes that adhere to industry standards and regulatory guidelines.
  • Continuous Training and Learning: Dr. Reem emphasizes the importance of ongoing training and education for all team members involved in manufacturing, testing, distribution, and pharmacovigilance activities.
  • Risk-Based Approach: Dr. Reem employs a risk-based method to identify and address risks to product quality and safety. This involves conducting risk assessments at various stages of the product lifecycle and implementing strategies to mitigate identified risks effectively.
  • Monitoring Adverse Events: Dr. Reem oversees the pharmacovigilance program to track, evaluate, and report events associated with the company’s products. This includes establishing procedures for detecting, assessing, and reporting events in accordance with regulatory standards.
  • Continuous Improvement Efforts: Dr. Reem takes the lead on improvement projects aimed at enhancing the efficiency and effectiveness of the organization’s quality management systems and pharmacovigilance practices. This involves investigating the root causes of quality issues, implementing preventive measures, and disseminating knowledge gained throughout the organization.
  • Keeping Up to Date and Adapting to Changes: Dr. Reem stays informed about shifts in rules, industry norms, and emerging updates in quality management and pharmacovigilance. This enables her to proactively adjust processes and protocols to ensure compliance with standards of quality and safety.

With these approaches, Dr. Reem ensures that Hawkary Pharmaceuticals Co. maintains top standards of quality and safety in its pharmaceutical products, thereby prioritizing the health and well-being of patients.

Prioritizing Compliance and Risk Management

At Hawkary Pharmaceuticals, Dr. Reem focuses on allocating resources based on risk assessments and compliance priorities, which may involve shifting resources, outsourcing tasks, or leveraging technology to streamline processes and maximize resource utilization. Additionally, she emphasizes investing in training programs to ensure that the team possesses the necessary skills and knowledge for compliance duties.

By recognizing and addressing these obstacles through careful planning, clear communication, and ongoing improvement efforts, Dr. Reem confirms that the organization remains aligned with regulations and industry norms while maintaining the highest standards of quality and safety for pharmaceutical products. This proactive approach not only mitigates risks but also fosters a culture of continuous improvement and excellence within the organization.

Quality Culture Leadership

Fostering a culture of excellence and adherence to rules within Dr. Reem’s team is crucial to ensure alignment with the company’s goals and regulatory standards. Here’s how she makes this happen:

  • Leading by Example: Dr. Reem demonstrates dedication to excellence and adherence to rules in all areas of her work, adhering to company policies, regulations, and industry norms, setting an example for her team members.
  • Communication: Dr. Reem emphasizes the importance of quality and compliance through regular interactions with her team. She discusses why adherence to rules and standards matters, keeps them informed about any changes in requirements, and clarifies expectations regarding quality performance.
  • Training and Growth: Dr. Reem invests in training and developing her team members to equip them with the knowledge and skills needed to maintain quality and compliance standards. This includes training on regulations, procedures, best practices, and offering opportunities for professional growth.
  • Responsibility: Dr. Reem empowers her team members to take ownership of maintaining quality and compliance within their roles. She assigns responsibilities, gives them the freedom to make decisions within set guidelines, and holds them accountable for their actions and results.
  • Recognition and Rewards: Dr. Reem ensures that team members who consistently maintain standards of quality and compliance are acknowledged and rewarded. This may involve giving praise, writing commendations, or other forms of recognition that highlight exemplary behavior and motivate continued excellence.
  • Continuous Improvement: Dr. Reem cultivates a culture of continuous improvement by soliciting feedback and ideas from team members on how to enhance processes related to quality and compliance. She encourages an environment where suggestions for improvement are welcomed, assessed, and implemented when appropriate.
  • Regular Feedback: Dr. Reem tracks quality and compliance metrics regularly to evaluate performance levels and identify areas for improvement. This includes conducting audits, analyzing performance indicators, and providing constructive feedback to team members to address any deviations from set standards.
  • Promoting Ethical Conduct: Dr. Reem emphasizes the importance of ethical behavior and integrity across all aspects of their work. She fosters an environment that prioritizes ethical decision-making and provides guidance on navigating ethical challenges that may arise.

In addition, Dr. Reem establishes a workplace where emphasis is placed on valuing quality assurance and adherence to compliance standards as integral parts of the team’s day-to-day activities. This ensures that everyone works together towards the company’s goals while also maintaining top-notch quality and integrity.

Continuous Improvement

As a certified ISO QMS consultant ( ISO 9001, ISO 22000 , ISO 13485 , ISP 31001 , ISO 45001 , etc.) and pharmacovigilance professional, Dr. Reem stays updated in quality management and pharmacovigilance through various methods. She attends relevant training programs, workshops, and conferences, often as a speaker, to gain insights into emerging trends and regulatory changes. Active participation in associations like ISoP and ASQ provides access to industry resources and networking opportunities.

Dr. Reem subscribes to industry publications and online forums for the latest research and expert opinions. Webinars and online courses further deepen her knowledge on regulatory compliance and risk management.

In industry groups and committees, Dr. Reem shares expertise and contributes to shaping standards. She also monitors regulatory updates from agencies like the FDA and EMA. Internally, she reviews quality systems and pharmacovigilance processes for continuous improvement and compliance. External audits offer additional insights into industry benchmarks and trends.

Through these efforts, Dr. Reem remains well-informed and equipped to assist her organization and clients effectively.

Investing in Talent

As a leader in her industry, guiding and supporting Dr. Reem’s team members in their growth and contribution to the company’s success is a top priority. Here’s how she mentors and develops them:

  • Personal Development Plans: Dr. Reem collaborates with each team member to create personalized development plans based on their skills, interests, and career goals, outlining objectives and steps for advancement.
  • Ongoing Feedback and Coaching: Regular feedback and coaching sessions help team members recognize strengths, areas for improvement, and avenues for progress, guiding them in skill enhancement and overcoming challenges.
  • Skills Training and Workshops: Organizing training sessions and workshops enhances analytical and soft skills, covering topics like quality management, pharmacovigilance, communication, project management, and leadership.
  • Mentorship and Peer Learning: Encouraging mentorship connections and peer learning opportunities within the team fosters knowledge sharing, skill-building, and overall development for both mentors and mentees.
  • Recognition and Rewards: Acknowledging and rewarding team members for their accomplishments and progress motivates ongoing excellence, whether through public praise, performance bonuses, promotions, or other incentives.
  • Leadership Development Programs: Identifying team members with leadership potential and offering them opportunities for leadership development initiatives builds essential competencies for future leadership positions.
  • Encouraging Initiative: Promoting a culture of innovation and encouraging team members to suggest and implement ideas fosters creativity, problem-solving skills, and proactive approaches to challenges.
  • Establishing Clear Expectations and Objectives: Setting clear expectations and goals aligned with the company’s strategic priorities empowers team members to understand their roles and work towards achieving results effectively.

By these growth strategies, Dr. Reem supports her team members in unlocking their capabilities, bringing value to the company, and fostering an environment of education, progress, and teamwork that strengthens the team’s capacity to reach its objectives.

Advancements in Quality Assurance and Pharmacovigilance

Dr. Reem, in her role as a leader in the pharmaceutical industry, highlights several emerging trends and advancements that are ready to shape the future of quality assurance and pharmacovigilance. One significant trend involves the integration of advanced analytical technologies such as artificial intelligence (AI), machine learning, and big data analytics. These technologies are expected to revolutionize quality assurance and pharmacovigilance by enabling more sophisticated data analysis, pattern recognition, and predictive modeling. By leveraging these capabilities, stakeholders can enhance risk evaluation, detect adverse events earlier, and make more informed decisions regarding pharmaceutical products.

Another noteworthy trend is the increasing recognition of real-world evidence (RWE) alongside traditional clinical trial data. RWE, derived from sources such as health records and patient registries, provides valuable insights into real-world usage patterns, outcomes, and safety profiles of medications.

There is a growing emphasis on patient-centered approaches in pharmacovigilance. This shift involves actively engaging patients, seeking their feedback, and involving them in reporting adverse events and managing risks associated with pharmaceutical products. By prioritizing patient perspectives and experiences, stakeholders can enhance medication safety and regulatory decision-making processes, ultimately improving overall healthcare outcomes.

Additionally, advancements in technology, such as blockchain, are gaining traction in managing pharmaceutical supply chains and monitoring drug safety. Blockchain’s transparency, traceability, and data integrity capabilities make it well-suited for ensuring the accountability of pharmaceutical products throughout their lifecycle.

Dr. Reem further adds that the integration of personalized medicine and pharmacogenomics is transforming pharmacovigilance by allowing for customized treatment approaches based on individual genetic factors, biomarkers, and disease characteristics. This personalized approach enables stakeholders to identify and manage drug risks more effectively, optimizing treatment outcomes and reducing adverse reactions.

Harmonizing Work and Life

Dr. Reem prioritizes maintaining a healthy work-life balance by spending quality time with loved ones and pursuing personal interests. She values the recharge and perspective gained from family and friends, ensuring her personal relationships remain strong despite her busy schedule. Additionally, Dr. Reem actively seeks opportunities for continuous learning and growth, whether through courses, workshops, or hobbies, to stimulate her intellectually and broaden her horizons.

Setting clear goals and expectations for herself, both professionally and personally, helps Dr. Reem manage her time and energy effectively. By focusing on tasks aligned with her objectives and seeking assistance when needed, she prevents feelings of overwhelm and stress. Dr. Reem also embraces adaptability, recognizing that balance requires ongoing adjustments to changing circumstances. This flexibility allows her to navigate challenges and transitions with resilience, both in her work and personal life.

Career Advice

Dr. Reem provides valuable advice for aspiring professionals looking to enter the field of quality assurance and pharmacovigilance within the pharmaceutical industry. She highlights the importance of acquiring a solid background in pharmaceutical sciences or related fields, along with pursuing additional training or certifications focused on quality management systems (QMS) and pharmacovigilance to enhance expertise. Developing strong problem-solving skills is crucial, particularly in analyzing data and making informed decisions. She also asserts that keeping abreast of industry trends and regulatory changes is essential, achieved through engagement with publications, conferences, associations, and networking opportunities.

According to Dr. Reem, professionals in these fields must cultivate effective communication and collaboration skills, given their interactions with diverse stakeholders. Upholding standards of quality, precision, and ethical behavior is paramount, demonstrating integrity in all actions. Adaptability to the evolving pharmaceutical landscape, along with a commitment to continuous learning and growth, is crucial. She stresses on seeking mentorship and expanding professional networks can provide valuable guidance and support for career advancement. Dr. Reem assures that staying curious and committed to ongoing improvement is key to success in quality assurance and pharmacovigilance.

Vision for Pharmaceutical Quality Assurance

In Dr. Reem’s vision for QA and PV’s future, she prioritizes innovation, safety, and continual improvement. Her strategies include leveraging new technologies like AI and blockchain, fostering innovation, strengthening collaboration, empowering her team, ensuring compliance, engaging stakeholders, and staying updated on industry trends.

With a focus on teamwork, fresh ideas, and ongoing enhancements, she believes that her guidance can lead to achieving goals and positively contributing to patient well-being, public welfare, and the pharmaceutical field as a whole.

Through these efforts, Dr. Reem’s aims to drive positive change, enhance patient outcomes, and contribute to the pharmaceutical field’s advancement.