Sme-pharmacovigilance

3 days ago

Mumbai Maharashtra, India Cognizant Full time

**Job Summary**

**Responsibilities**
- Triage & intake of ICSRs in ARGUS databases within agreed timelines
- Download and monitor valid ICSRs from Eudra Vigilance (EV)
- or any other sources
- Process literature, spontaneous, clinical trial, and solicited cases
- Search for valid ICSRs in Literature search tools
- Generate reports and submit to health authorities and business partners
- Enter serious and non-serious ICSRs in ARGUS per client SOP and WI with high accuracy
- Code events, indications, patient history using MedDRA
- Code suspect products, amend narratives, and label events
- Obtain follow-up information for all cases per applicable guidelines
- Submit processed cases to regulatory authorities and distribute reports to Partners
- Communicate effectively with client stakeholders and internal teams
- Attend all internal and client trainings to ensure guideline compliance
- Ensure adherence to regulatory requirements and industry standards in all aspects of pharmacovigilance and safety operations.
- Assist in the development and maintenance of standard operating procedures to ensure consistency and quality in process execution.
- Support training and development initiatives to enhance team capabilities and knowledge in pharmacovigilance and safety operations.
- Utilize technical skills to troubleshoot and resolve process-related issues, minimizing disruptions and ensuring smooth operations.
- Engage in rotational shifts to provide consistent support and coverage across different time zones.

**Requirements**:

- Bachelor’s / Master’s degree in pharmacy.
- Minimum 3 years relevant work experience in case processing activities.
- Experience in Cardiovascular (CVS), Neuroscience (CNS), Oncology, Immunology therapeutic areas and Gene Therapy will be an added advantage. Experience with global pharma sponsor will be preferred.
- In-depth knowledge and understanding of applicable global, regional, and local regulatory requirements, including Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and International Conference of Harmonization (ICH) guidelines, SOPs.
- Excellent organizational and time management skills.
- Good knowledge of medical terminology.

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