Pharmacovigilance
At Ocean Pharmaceutical, Pharmacovigilance is a core function that ensures the continued safety and quality of medicinal products through a proactive and compliant safety monitoring system. We continuously collect and evaluate Adverse Event (AE) data to identify, assess, and mitigate potential risks associated with medicinal products. Every adverse event report, no matter how minor it may seem, provides valuable insight into how products perform in the real world. By collecting and analyzing these reports, we can identify new risks, update product safety information, support regulatory decisions, and most importantly, protect the well-being of patients worldwide.
We encourage healthcare professionals, patients, caregivers, and partners to report any AEs associated with our products. Your reports help us make medicines safer and lead to better patient outcomes.
What is an Adverse Event (AE)?
An Adverse Event (AE) is any unexpected or unwanted medical problem that occurs after using a medicine, vaccine, or medical device.
It doesn’t always mean the product caused the problem, but it happened around the time you were taking or using it.
For example:
- Feeling dizzy after taking a medicine
- Redness or swelling after a vaccine
- Headache while using a medical device
Most side effects are mild, but some can be serious. That’s why reporting them is important- it helps doctors, companies, and health authorities keep medicines and devices safe for everyone.
If you experience any unusual symptoms, always inform your doctor or pharmacist and report them to us.
How to Report an Adverse Event
Healthcare professionals, patients, partners, and other stakeholders can report adverse events through multiple channels quickly and securely:
Email: Send AE details to our dedicated pharmacovigilance team at Sales@oceanpharmaceutical.com
Online AE Reporting Form: Available 24/7 on our website for convenient digital submission. Report an AE Now
Adverse Event Reporting Number: +91-95122 22579
Timing: 9:00 AM to 6:00 PM – Monday to Friday.
For detailed reporting, click to download the Adverse Event Reporting Form.
Please fill out the AE form and send it back to us via:
Email:Sales@oceanpharmaceutical.com
OR
Postal Address
305\A, Sarjan Complex, Opp. Bank of Baroda, Pratap Road, Dandia Bazar, Vadodara – 390001 Gujarat, India.
Information Required for Adverse Event Reporting
To process an AE report effectively, the following minimum information is required:
- Treatment dates and outcome, if available
- Reporter’s contact details (for follow-up; optional for consumers)
- Patient details (initials, age, gender – without personal identifiers)
- Description of the adverse event
- Name of the suspected product
What Happens After You Report an Adverse Event
- Acknowledgement & Case Intake: Each report is documented and recorded in our database.
- Case Assessment: Medical and safety professionals assess seriousness, expectedness, and causality.
- Regulatory Submission: Cases meeting regulatory criteria are reported to health authorities within specified timelines.
- Ongoing Monitoring: All cases contribute to signal detection, risk evaluation, and benefit-risk assessment of products.
- Inclusion in Safety Reports: AEs are summarized in safety reports, and are submitted regulatory authorities.
Why Adverse Event Reporting Matters
- Builds trust in healthcare
- Protects public health
- Improves patient safety
- Helps improve medicines and medical devices
- Identifies rare or long-term side effects
- Supports early detection of safety issues
- Fulfills legal and regulatory obligations
Data Protection & Confidentiality
Ocean Pharmaceutical adheres strictly to data protection laws (e.g., GDPR, HIPAA, DPDP) and pharmacovigilance standards. All information is handled confidentially and used solely for safety monitoring purposes.