Vantive is a leading vital organ therapy company dedicated to extending lives and expanding possibilities for patients and care teams worldwide. With a 70-year legacy of innovation in kidney care, Vantive is now transforming vital organ therapies through digital solutions, advanced services, and a commitment to improving patient outcomes. Our mission is to provide greater flexibility and efficiency in therapy administration for care teams while enabling longer, fuller lives for patients.
At Vantive, we foster a culture of focus, courage, and excellence. We are a community of professionals driven by a shared goal: to improve patients’ lives globally. Join us in advancing our mission and making a meaningful impact in the field of pharmacovigilance and patient safety.
Job Description:
As an Associate, Pharmacovigilance (PV), you will play a critical role in ensuring compliance with Vantive’s pharmacovigilance quality systems and policies. You will be responsible for managing adverse event (AE) case intake, performing case assessments, and supporting safety risk management activities. This role is based in Gurgaon, Haryana, India, and offers an opportunity to contribute to global patient safety efforts.
Key Responsibilities:
- PV Quality Systems:
- Ensure compliance with Baxter Pharmacovigilance Quality systems and policies.
- Manage document retention, archiving, and training requirements.
- Adhere to the Business Continuity Plan (BCP).
- Perform due diligence for third-party agreements.
- Case Intake and Management:
- Manage the receipt and capture of adverse event (AE) and pregnancy reports in the Pharmacovigilance safety database.
- Handle AE reports from various sources, including patients, healthcare professionals (HCPs), regulatory authorities, social media, and clinical studies.
- Perform initial case assessments, including validity, seriousness, and duplicate checks.
- Ensure all source documents are accurately captured in the database.
- Request and manage follow-up information, reassess case validity, and update the database accordingly.
- Safety Risk Management:
- Support the Qualified Officer in implementing risk minimization measures.
- Perform surveillance activities to identify potential safety concerns and escalate as per procedures.
- Other Responsibilities:
- Escalate safety-related requests from regulatory authorities to the Qualified Officer.
- Update the Pharmacovigilance Officer in Charge (PVOIC) on all PV activities and safety issues.
- Register cases in the Pharmacovigilance Safety System (PSS) within defined timelines.
- Respond to queries from country PV teams and global service providers.
Qualifications:
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related field.
- Prior experience in pharmacovigilance, drug safety, or a related area is preferred.
- Strong understanding of pharmacovigilance regulations and guidelines.
- Excellent attention to detail and organizational skills.
- Proficiency in using pharmacovigilance databases and tools.
- Strong communication and interpersonal skills.
How to Apply:
