Pharmacovigilance & Compliance Executive – Hyderabad: Shape the Future of Patient Safety
Summary:
We are seeking a highly motivated and detail-oriented Pharmacovigilance & Compliance Executive to join our growing team in Hyderabad. This is an excellent opportunity for an early-career professional with a passion for patient safety and a desire to advance their career in the dynamic field of pharmaceutical regulatory compliance. As a vital member of our pharmacovigilance team, you will be responsible for monitoring, analyzing, and reporting adverse drug reactions (ADRs) while ensuring adherence to global pharmacovigilance regulations. If you possess a strong foundation in pharmaceutical sciences, a keen understanding of regulatory guidelines, and excellent documentation skills, we encourage you to apply.
About the Role:
As a Pharmacovigilance & Compliance Executive, you will play a critical role in safeguarding patient health by contributing to the continuous monitoring and reporting of drug safety. Your responsibilities will encompass the entire ADR lifecycle, from initial identification and analysis to timely reporting to regulatory authorities. You will also be instrumental in maintaining accurate and comprehensive safety documentation and ensuring compliance with global regulatory standards.
Key Responsibilities:
- ADR Monitoring and Analysis: Monitor, collect, and analyze adverse drug reaction (ADR) reports as part of the pharmacovigilance process, identifying potential safety signals and trends.
- Regulatory Reporting: Ensure the timely and accurate reporting of ADRs to regulatory authorities in accordance with global (ICH, GVP) and local guidelines, adhering to strict deadlines and reporting requirements.
- Documentation and Record Keeping: Maintain meticulous and accurate documentation of safety data and case-processing records in a regulated environment, ensuring data integrity and audit readiness.
- Cross-Functional Collaboration: Collaborate effectively with internal teams, including regulatory affairs, quality assurance, and clinical development, to ensure all compliance-related documentation is prepared, maintained, and readily accessible.
- Regulatory Updates and Compliance: Stay abreast of the latest changes and updates in pharmacovigilance and compliance regulations (FDA, EMA, ICH, local Indian requirements), proactively adapting processes and procedures to maintain compliance.
- Auditing and Process Improvement: Assist in internal audits and contribute to process-improvement efforts related to safety and compliance functions, identifying areas for optimization and efficiency.
- Risk Management: Contribute to the assessment and mitigation of potential risks associated with drug safety, providing insights and recommendations to minimize patient harm.
Qualifications & Skills:
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related field.
- 1-2 years of experience in pharmacovigilance and compliance within the pharmaceutical industry.
- Working knowledge of global PV regulations such as ICH guidelines, GVP modules, FDA and EMA safety expectations.
- Demonstrated ability to prioritize tasks, meet deadlines, and handle safety data with sensitivity and confidentiality.
- Excellent attention to detail, strong documentation skills, and the ability to thrive in a regulated environment.
- Excellent communication skills (written and verbal) to interact effectively with internal teams and prepare comprehensive compliance reports.
- Proficiency in using pharmacovigilance databases and software systems is preferred.
- Ability to work independently and as part of a team, demonstrating initiative and problem-solving skills.
Why Join Our Team?
- Impactful Role: You will have the opportunity to contribute to a highly regulated and impactful domain—pharmacovigilance and compliance—within the pharmaceutical industry, directly influencing patient safety and regulatory integrity.
- Career Growth: Gain valuable exposure to global compliance standards and regulatory frameworks, enriching your career trajectory in pharmaceutical safety and opening doors to future advancement opportunities.
- Strategic Location: Based in Hyderabad—a major pharma and life sciences hub—offering unparalleled networking and professional growth potential.
- Continuous Learning: Engage in continual learning and professional development within a safety-critical role that directly supports patient welfare and regulatory integrity, keeping you at the forefront of industry best practices.
- Dynamic Environment: Be a part of a dynamic and collaborative team, contributing to a culture of innovation and continuous improvement.
Application Instructions:
Are you ready to take the next step in your PV & compliance career? Please submit your resume to [email protected] with the subject line: “Application – Pharmacovigilance & Compliance Executive – Hyderabad”. Ensure your resume highlights your relevant 1-2 years’ experience, understanding of pharmacovigilance regulations, and any exposure to compliance documentation. We look forward to hearing from you!