Casestudy

Developing Risk Management Strategy for a Pharma Manufacturer

Author: Rajesh

Case Study Overview

Client Industry Solution
Global Pharmaceutical ManufacturerPharmaceuticals, Packaging, Logistics, and WarehousingIdentified and Helped in the Implementation of an Ideal Risk Management Strategy in Pharmaceutical Industry

About the Client

A renowned global pharmaceutical manufacturer

Client Requirement

The client was encountering a complex array of challenges that could have been manageable if they had been identified and addressed proactively. Unfortunately, these challenges that affected the supply chain led to substantial losses. Facing increasing pressure from the market and stakeholders to implement more proactive strategies, the company turned to SpendEdge for assistance in developing a comprehensive risk management strategy.

Risk Management in the Pharmaceutical Industry

Common risks affecting the pharmaceutical industry include intensifying competition, changing regulations and policies, patent expirations of medicinal products, geopolitical crises such as political instability, and fluctuations in raw material prices over product life cycles. Also, quality control and quality risk management are critical for the pharmaceutical industry. An effective risk management strategy allows companies to tackle these risks with caution, preparation, actionable insights, and comprehensive plans. Organization, coordination, and a proactive mindset can help minimize major risks and mitigate minor ones. However, to reap the benefits of a risk management strategy, it must be effectively planned, implemented, and adapted over time to align with the evolving needs, expectations, and goals of the business. Risk management in pharmaceutical industry is becoming increasingly challenging due to factors such as constantly fluctuating market dynamics, continuous technological and industrial developments, and legal changes.

What are the Various Steps Involved in Developing and Implementing a Risk Management Strategy?

Identification:

Companies should engage in collaborative communication with stakeholders to identify potential risks across departments and systems, considering factors such as changing laws and market fluctuations.

Assessment:

Risk management teams must evaluate each identified risk based on urgency, impact, and likelihood to prioritize effectively and allocate resources efficiently.

Mitigation:

While not all risks can be eliminated, companies should focus on minimizing the impact of unavoidable risks by prioritizing high-risk challenges and developing actionable plans.

Monitoring:

After implementing the mitigation plan, teams need to continuously re-evaluate risks and track key metrics to assess the effectiveness of the risk management strategy.

Reporting:

Compiling and presenting all relevant data allows companies to evaluate the efficacy of their risk management strategies and identify opportunities for improvement.

Step 1: Identification:

Every supply chain and organization faces vulnerabilities that vary in severity, duration, and impact. To address these effectively, companies should engage in collaborative communication with stakeholders to identify potential risks across departments and systems. This involves discussing risks with team managers, employees, and partners and compiling a comprehensive list for action. Factors such as changing laws, demand and supply fluctuations, raw material prices, and other internal and external influences should be examined.

Step 2: Assessment:

Once potential risks are compiled, risk management teams should assess each risk based on urgency, impact, and likelihood. Accurately prioritizing these risks can help companies focus on critical challenges, minimize the risk of further issues, allocate resource efficiently, and reduce chances of risks being overlooked. Creating a comprehensive risk matrix to analyze factors like likelihood and impact can be beneficial for enabling team leaders to collaborate effectively throughout the development and implementation of the risk management strategy.

Step 3: Mitigation:

Evaluating and mitigating all potential risks can be challenging. However, an effective risk management strategy can simplify identification and assessment of all risks. While not every risk can be mitigated, the focus should be on minimizing the impact of unavoidable ones. Prioritizing high-risk challenges can enable the team to address all listed risks in order of importance. Also, companies should develop a plan of action to implement if an unavoidable risk materializes.

Step 4: Monitoring:

Once the mitigation plan is implemented, risk management teams must re-evaluate the priority and severity of specific issues to determine the efficacy of the implemented strategy. This involves collaborating with all departments and stakeholders, tracking key metrics, and assessing the overall effectiveness of the risk management strategy. During this phase, department leaders should maintain open communication and encourage their teams to remain vigilant for any incidents.

Step 5: Reporting:

Compiling, evaluating, and presenting all relevant data and approaches used can enable companies to assess the efficacy of the strategy and make necessary adjustments for future iterations. This process will provide stakeholders with important information about major risks, actions taken, and the status of potential or existing risks, while facilitating identification of improvement opportunities and essential insights into overall management and resolution of identified challenges.

Success Story – SpendEdge Advantage

Solution

The client was encountering a complex array of challenges that could have been manageable if they had been identified and addressed proactively. Facing increasing pressure from the market and stakeholders to implement more proactive strategies, the company turned to SpendEdge for assistance in developing a comprehensive risk management strategy. Our experts utilized their more than 18+ years of experience related to risk management strategy development to assist the company in conducting a thorough, effective, and precise risk assessment, which, in turn, facilitated the evaluation and identification of risk mitigation strategies. SpendEdge experts also provided appropriate software solutions that could efficiently monitor the various risks and established a sustainable reporting system to enhance transparency and accountability.

Outcome

With the new approach based on the comprehensive risk management strategy developed by our experts, the pharmaceutical client was able to successfully navigate the various risks and challenges it had been facing. This strategic overhaul allowed the client to recover from previous setbacks and build resilience against future threats.

By implementing this robust risk management framework, the client was able to establish a highly efficient proactive system that not only addressed its current challenges but also anticipated potential risks before they could escalate. The enhanced focus on risk assessment and mitigation empowered the organization to make informed decisions, streamline operations, and ultimately improve overall performance. This transformation also positioned the client to respond swiftly to market changes, enhance its competitive advantage, and achieve sustainable growth in an increasingly complex industry landscape.

FAQs

Common risks in the pharmaceutical industry include intensifying competition, changing regulations, patent expirations, geopolitical crises, and fluctuations in raw material prices. Quality control and quality risk management are also critical. An effective risk management strategy can enable companies to address these risks comprehensively with caution. Organization, coordination, and a proactive mindset can help minimize major risks and mitigate minor ones. However, to benefit from a risk management strategy, it must be well-planned, implemented, and adapted over time to align with evolving business needs and goals. Risk management in the pharmaceutical industry is becoming increasingly challenging due to fluctuating market dynamics, ongoing technological developments, and legal changes.

The number of economic, social, financial, political, and legal risks across industries has grown exponentially over the years, prompting companies to seek an ideal risk management strategy that can help them to effectively manage aspects such as regulatory compliance, quality control, and contamination risks.

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