Wipro Limited is an Indian multinational corporation that provides information technology, consulting and business process services. Thierry Delaporte is serving as CEO and managing director of Wipro since July 2020.
Inviting application for Drug Safety Associate –
- Role – Drug Safety Associate (Case Processor)
- Work Location – Pune
- Qualification – M. Pharm/B. Pharm/BAMS/BHMS/Pharm D/BDS
- Experience – 0 – 7 Years in PV.
- Immediate joiners will be preferable.
Job Description:
1. Reviewing the published reports/biomedical literature to ascertain if they contain a case report of an adverse reaction and Non-individual case reports.
2. Applying regulatory and internal guidance to determine if the article meets the definition of a case report and Non-individual case reports.
3. Write accurate and concise summaries that capture the key elements from these published reports.
4. Ensure consistent coding of medical history, drugs and adverse event terms.
5. Evaluation of Serious Adverse Event to ensure accurate processing from source documents with emphasis on quality and timelines.
6. Creating summary content in a range of formats (narrative summaries, structured database inputs, electronic formats for regulatory filing) to support the drug safety reporting and information requirements of Pharma industry client.
7. To contribute/support the project through query resolution of peer team members.
8. To perform other responsibilities delegated by the team lead/manager.Technical / Functional Competency:
1. Sound knowledge of regulatory guidelines related to PV domain.
2. Narrative Writing
3. MeDRA Coding
4. Sound knowledge of Pharmacological concepts
5. Command on Verbal and Written communication skills.
6. Team player
Pls share relevant Cv’s on – [email protected]
Inviting Applications for Drug Safety Physician –
- Role – Drug Safety Physician
- Work Location – Pune
- Qualification – MBBS/MD – Pharmacology
- Experience – 0.6 – 2 Years
- Immediate joiners will be preferable.
Role & Responsibility:
1. Reviewing the published reports/biomedical literature to ascertain if they contain a case report of an adverse reaction and Non- individual case reports.
2. Applying regulatory and internal guidance to determine if the article meets the definition of a case report and Non- individual case reports.
3. Perform relevancy assessment based on accepted industry guidelines.
4. Provide training and guidance to the scanners on inclusion criteria of case report and Non- individual case reports.
5. Work closely with the SMEs to ensure physician team has necessary training and skills per industry norms.
6. Perform additional tasks/responsibilities as assigned delegated by the team lead/managerTechnical/Functional Competency:
1) Sound Knowledge of Human Anatomy & Physiology
2) MedDRA Coding & subsuming of adverse drug reaction/AE terms
3) Seriousness determination
4) Familiarity with pharmacological concepts
5) Sound knowledge of Guidelines of Pharmacovigilance and Latest updates about Pharmacovigilance
6) Command on verbal and written communication skills
7)Team Player
Pls share relevant CV’s on – [email protected]
