Case Medical Safety Expert

2 days ago

Remote, India IQVIA Full time

Major duties and responsibilities:

- oversees the Medical Review (MR) of ICSRs as per predefined activity and job-role in PV safety database, with special focus on case medical accuracy and documentation, - maintains overall accountability for the timeliness and quality of medical case management activities outsourced to service providers, - leads or participates in cross-functional projects or initiatives within Global Pharmacovigilance collaborates with the GSO in the review of Clinical trial and post-marketing program documentation and on labeling activities, - establishes strong collaboration with cross-functional groups within and outside the company (i.e Business Partners, CRO), - is the SME during internal / partner audits and inspections

Skills and Education:

- MD or Physician
- 3 to 5 years of experience in healthcare-related field and/or patient-care activities desirable
- 3+ years of Pharmacovigilance experience or equivalent relevant pharmaceutical industry experience (clinical development, data management, etc.)
- Supervisory and mentoring experience highly desirable
- Thorough medical knowledge of the safety profile of assigned products
- Experience in pharmacovigilance databases
- Robust expertise with MedDRA coding
- Thorough knowledge of regulations (e.g. FDA, EMA )
- Computer literacy, especially MS Office programs
- Able to communicate, verbally and in writing in a good and understandable English level
- Able to influence and establish strong collaborations with cross-functional groups within and outside the company
- Able to prioritize activities and demonstrate high quality of work, flexibility

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