Job Title: PV Specialist (Pharmacovigilance Specialist)
Location: Ahmedabad, Gujarat
About Baxter
At Baxter, we are driven by a singular mission: to save and sustain lives. We are a global healthcare leader, innovating at the intersection of science and technology to improve patient outcomes. Our products and therapies are essential in hospitals, clinics, and homes worldwide. We are committed to providing a diverse and inclusive workplace where our employees can thrive and make a meaningful impact.
Job Summary
Baxter is seeking a detail-oriented and highly skilled PV Specialist (Pharmacovigilance Specialist) to join our Global Patient Safety (GPS) team in Ahmedabad, Gujarat. As a PV Specialist, you will be responsible for the processing and management of individual case safety reports (ICSRs), ensuring accurate and timely documentation of adverse events. This role is crucial in supporting Baxter’s commitment to patient safety and contributing to our mission of saving and sustaining lives.
Responsibilities
As a PV Specialist, your key responsibilities will include:
- Adverse Event Report Processing: Manage and process adverse event reports received from various reporting sources.
- Data Entry and Review: Conduct thorough review and complete data entry of adverse event cases into the pharmacovigilance database.
- Assessment and Analysis: Determine the seriousness, expectedness, causality, and conduct a medical assessment of adverse events.
- Drug Selection: Ensure accurate suspect drug selection within the PV safety database.
- Narrative Writing: Develop clear, concise, and high-quality medical narratives for adverse event cases.
- MedDRA Coding: Accurately code medical terms using MedDRA and other standardized dictionaries.
- Data Integrity: Ensure complete and accurate data coding, maintaining case integrity throughout the process.
- Follow-Up and Investigation: Coordinate with global and local affiliates to obtain necessary follow-up information and conduct case investigations.
- Quality Control: Perform quality checks and case clean-up activities to ensure data accuracy for aggregate reporting.
- Compliance and Timeliness: Adhere to strict timelines, compliance standards, and maintain high attention to detail in all aspects of the role.
Qualifications
To be successful in this role, you should possess the following qualifications:
- Education: Bachelor’s degree in Nursing, Pharmacy, Life Sciences, or a relevant scientific discipline.
- Experience: 2–3 years of experience in hospital care, pharmaceutical safety, or regulatory roles is preferred.
- Medical Knowledge: Strong medical and clinical knowledge base.
- Communication Skills: Excellent written and verbal communication skills.
- Pharmacovigilance Knowledge: Familiarity with global pharmacovigilance regulations and guidelines.
- Teamwork and Independence: Ability to work both independently and as part of a collaborative team.
- Systems Experience: Experience with Pharmacovigilance Safety Systems is preferred.
Benefits
Joining Baxter offers a rewarding career experience with numerous benefits, including:
- Impactful Contribution: Opportunity to contribute directly to global patient safety initiatives.
- Inclusive Culture: Inclusive, diverse, and collaborative work environment.
- Competitive Compensation: Competitive salary and benefits package.
- Career Development: Opportunities for career growth within a global healthcare leader.
- Advanced Systems: Exposure to advanced Pharmacovigilance systems and global processes.
How to Apply
If you are a qualified and passionate individual looking to make a difference in patient safety, we encourage you to apply. Please submit your application through the Baxter careers website. We look forward to reviewing your application.