Pharmacy Job at Baxter | Apply Now for the Spec, PV Role
Baxter, a global leader committed to saving and sustaining lives, is hiring a Specialist, Pharmacovigilance (PV) to join its Safety Operations team in Ahmedabad, Gujarat. This Pharmacy Job involves serving as a case owner for adverse event reports, ensuring the accurate and timely processing, quality control, and reporting of individual case safety reports (ICSRs). Ideal candidates should possess a Degree in Nursing, Pharmacy, or Science, preferably with 2-3 years of relevant experience in the pharmaceutical industry or patient care, along with strong working knowledge of worldwide safety regulations.
- Job Post: Spec: PV
- Location: Ahmedabad, Gujarat, India
- Job ID: 190289
Baxter Job Description
This position is a member of the Safety Operations team within Global Patient Safety (GPS). This position serves as a team member for individual case safety report processing and as case owner for adverse event reports to ensure timely and accurate review, processing, quality control, and reporting.
Essential Duties and Responsibilities:
- Process adverse event reports from all source types including review and full data entry of adverse event reports determining seriousness, expectedness, reporter’s causality and overall event resolution
- Ensure that the correct suspect drug is selected withing the Pharmacovigilance Safety System
- Write narratives summarizing all relevant medical information for individual case safety reports
- Code medical terms using standardized medical dictionaries (e.g., MedDRA)
- Using medical expertise, ensure that all data has been entered and coded correctly in the database
- Request case investigation to gather all required medical information, including query generation, tracking and follow up with reporters in conjunction with local affiliates
- May perform quality checks as requested/necessary
- May perform case clean-up as required for preparation of aggregate reports
Qualifications required for the Baxter Job
- Medical and clinical knowledge
- Excellent oral and written communication
- Operates effectively in a team environment
- Ability to work independently under strict deadlines and changing priorities with some supervision
- Ability to multi-task and prioritize changing workload on a daily basis
- Working knowledge of worldwide and regional safety regulations
- Ability to establish proficiency working in the Pharmacovigilance Safety System
Education and/or Experience
- Degree in pharmacy, science degree or equivalent
- Experience in the pharmaceutical industry (Regulatory or Safety) preferred
- 2-3 years of hospital, patient care or equivalent experience preferred