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Pharmacovigilance

4 weeks ago

Ahmedabad Gujarat, India Fusion Market Research Full time

Responsible for the evaluation & quality check of Individual Case Safety Reports (ICSR), and writing aggregated safety reports within agreed timeframes and to a high standard of accuracy, in compliance with DS&E business rules, standard operating procedures and global regulatory requirements.

1. Assess seriousness, causality and labeling of serious adverse events and quality check ICSRs to ensure accurate and consistent Argus data entry from source documents.

2. Author/co-author, along with Global Medical Safety Physicians, regulatory periodic safety reports (Periodic Safety Update Reports, US Periodic Reports) for Novartis mature portfolio: collecting, organizing, analyzing and presenting the data by means of DS&E templates and procedures.

3. Lead/co-lead cross functional expert teams to fulfill Periodic Safety Report accountabilities (DRA, Clinical, Marketing).

4. Review global marketing programs and establish process for AEs collection with global marketing teams.

5. Review Risk Management Plans in coordination with Global Medical Safety groups and assess the operational feasibility and implications of pharmacovigilance commitments.

6. Collaborate with Electronic Data Management team to reconcile Serious Adverse Events between the Clinical and Safety databases to meet joint accountabilities and enable locking of Clinical database.

7. Alert the Medical Safety Physicians of potential safety issues and assist the Medical Safety Physicians in monitoring the safety profile of products.

8. Member of Safety Profiling Teams to ensure that case reports are accurately evaluated and databased, authoring or contributing to Product Specific Guidelines for assigned products.

9. Contribute to the preparation of Standard Operating Procedures and Argus processing conventions (MAP).

11. Support Health Authorities inspections and audits, and development of Corrective & Preventative Actions (CAPA) to address safety findings.

12. Train and mentor new DS&E associates. Key Performance Indicators (Indicate how performance for this role will

**Job Types**: Full-time, Permanent, Fresher

Pay: ₹25,144.08 - ₹48,896.78 per month

**Benefits**:

- Health insurance
- Paid sick time

Schedule:

- Day shift
- Monday to Friday

Supplemental Pay:

- Joining bonus
- Performance bonus
- Yearly bonus

**Experience**:

- total work: 1 year (preferred)

Work Location: In person