Are you an experienced pharmacovigilance professional looking for a rewarding opportunity? A reputed pharmaceutical company in Sanathnagar, Hyderabad, Telangana, India, is hiring for the role of Executive/Senior Executive – Pharmacovigilance. This is a permanent position for candidates with 5 to 7 years of experience in drug safety and adverse event reporting.
About the Company
The hiring company is a leading pharmaceutical organization committed to delivering high-quality healthcare solutions worldwide. With a strong focus on patient safety and regulatory compliance, the company’s Pharmacovigilance Department plays a crucial role in monitoring drug safety and ensuring adherence to global regulatory standards.
Job Responsibilities
As an Executive/Senior Executive in Pharmacovigilance, your key responsibilities will include:
- Processing and analyzing safety data from multiple sources to ensure compliance with drug safety regulations.
- Tracking cases through processing activities and coordinating workflows for accurate reporting.
- Performing quality checks of Individual Case Safety Reports (ICSRs) to verify completeness, accuracy, and consistency of data in the safety database.
- Reviewing case quality to ensure compliance with guidelines and regulatory requirements while providing feedback to case processors.
- Reporting ICSRs to regulatory authorities within required timelines and in accordance with pharmacovigilance SOPs.
- Conducting periodic reconciliation of Serious Adverse Events (SAEs) between global and regional drug safety teams.
Qualifications & Experience
To be considered for this role, candidates must meet the following criteria:
- Educational Qualification: Bachelor’s or Master’s degree in Pharmacy (B.Pharm/M.Pharm), Life Sciences, or a related field.
- Experience: 5 to 7 years of experience in Pharmacovigilance, Drug Safety, or Clinical Research.
- Regulatory Knowledge: Understanding of global pharmacovigilance regulations, including FDA, EMA, and CDSCO guidelines.
Key Skills Required
- Strong expertise in case processing and adverse event reporting.
- Excellent knowledge of safety databases and pharmacovigilance tools.
- Ability to review and validate safety reports for accuracy and compliance.
- Attention to detail and ability to handle large volumes of data efficiently.
- Strong communication and teamwork skills to coordinate with global teams
