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Name of Position: Pharmacovigilance Service Associate
Skill Required: Pharmacovigilance – Pharmacovigilance & Drug Safety Surveillance
Qualification: BSc/Bachelor of Pharmacy/Master of Pharmacy
Experience: 1 to 3 Years
Requirements
- Ability to work well in a team
- Adaptable and flexible
- Agility for quick learning
- Commitment to quality
Pharmacovigilance experience
- A minimum of 1 years’ experience in pharmaceutical or clinical research preferred.
- Knowledge of medical terminology including knowledge of applicable dictionaries like MedDRA and WHO-Drug
- Good medical writing skills
- Good Communication Skills
- Analytical Ability
- Strong English Language proficiency
Roles and Responsibilities
- Prioritise case processing activities for ICSRs in accordance with project guidelines, Regulatory due date and TAT SLAs and KPIs.
- Processing and evaluation of Individual Case Safety Reports
- Consistent data entry and processing from source documents, adhering to timelines and quality.
- Confirm accurate and consistent coding of medical history, drugs and adverse event terms.
- Assess adverse event reports for seriousness, causality and expectedness as per applicable labeling, consulting the Medical Reviewer whenever needed.
- Alert the Medical Reviewer of potential safety issues and assist the Medical Reviewer in monitoring the safety profile of product as appropriate.
- Determine if any additional information is needed for clarification, or if any follow-up is necessary, and take all relevant steps to obtain any additional/missing information as stated in the relevant Project SOP.
- Archive all communications/clarifications related to the Case in the Global Safety Database.
- Initiate and handle case deletions/ nullification as appropriate.
- To participate in audits or inspections.
- Open to get trained and moved across roles based on business requirement.
- Training and mentoring to new associates.
- Authoring of process documents.
Last Date: 15 July 2023
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