Job Summary
The TM-Pharmacovigilance role involves ensuring the safety and efficacy of pharmaceutical products through vigilant monitoring and analysis. With a focus on regulatory intelligence the candidate will contribute to maintaining compliance and enhancing customer service. This hybrid role requires rotational shifts and proficiency in English with no travel obligations.
Responsibilities
Monitor and analyze adverse drug reactions to ensure patient safety and product efficacy.Collaborate with cross-functional teams to gather and interpret regulatory intelligence data.Provide expert guidance on pharmacovigilance processes to enhance customer service experiences.Develop and implement strategies for effective risk management and mitigation.Ensure compliance with global regulatory standards and guidelines in pharmacovigilance activities.Oversee the preparation and submission of regulatory reports and documentation.Conduct thorough research to support the development of new pharmacovigilance methodologies.Facilitate communication between stakeholders to ensure seamless regulatory affairs processes.Utilize advanced analytical tools to assess and improve pharmacovigilance systems.Lead initiatives to optimize research and development efforts in drug safety.Support the integration of regulatory intelligence into strategic planning and decision-making.Drive continuous improvement in pharmacovigilance practices to benefit public health.Maintain up-to-date knowledge of industry trends and regulatory changes. QualificationsPossess strong expertise in customer service within the pharmacovigilance domain.Demonstrate proficiency in regulatory intelligence and its application in drug safety.Have experience in regulatory affairs and research and development as a nice to have skill.Exhibit excellent communication skills in English both written and spoken.Show ability to work effectively in a hybrid work model with rotational shifts.Display a commitment to maintaining high standards of compliance and safety.Bring a proactive approach to problem-solving and process improvement.
Certifications Required
Certified Pharmacovigilance Professional Regulatory Affairs Certification - B.Pharm/M.Pharm
