Opening for Senior Pharmacovilance Scientist @ Novartis Pharmaceuticals - Hyderabad, Andhra Pradesh
Responsible for the processing, evaluation and quality check (QC) of Serious Adverse Event / Post Marketing Adverse Event, within agreed timeframes and to a high standard of accuracy, in compliance with DS&E business rules, standard operating procedures and global regulatory requirements. Major Activities (Describe main activities) 1. Evaluation and QC of Serious Adverse Event / Post Marketing Adverse Event to ensure accu-rate and consistent data entry and processing from source documents, with emphasis on timeliness and quality. 2. Ensure accurate and consistent coding of medical history, drugs and adverse event terms. 3. Assess adverse event reports for seriousness, causality and expectedness as per the Investiga-tor Brochure/Basic Prescribing Information/US package insert, consulting the Medical Safety Expert whenever needed. 4. Determine the necessity for follow-up and prepare follow-up request as needed. 5. Work in conjunction with Clinical Safety Associates, Clinical Safety Scientists from other proc-essing sites and Medical Safety Physicians (Pharmacovigilance Leader and Brand Safety Leader) to ensure that reports are accurately evaluated and databased. 6. Triage literature cases for databasing or pass them on to the Team Leader for approval of re-jection. 7. Co-author, together with the Medical Safety Physicians, all required regulatory periodic re-ports, collecting, organizing and presenting the available data. 8. Work with external partner groups, e.g. co-licensing
Minimum requirements
PhD or PharmaD desirable Bachelors or Master degree in Life sciences or Pharmacy / Advanced Nursing as a minimum requirement English Relavant Experience in Slotted Corp Aff
Click here to apply directly
Wants to Learn Pharmacovigilance???? Click here
Responsible for the processing, evaluation and quality check (QC) of Serious Adverse Event / Post Marketing Adverse Event, within agreed timeframes and to a high standard of accuracy, in compliance with DS&E business rules, standard operating procedures and global regulatory requirements. Major Activities (Describe main activities) 1. Evaluation and QC of Serious Adverse Event / Post Marketing Adverse Event to ensure accu-rate and consistent data entry and processing from source documents, with emphasis on timeliness and quality. 2. Ensure accurate and consistent coding of medical history, drugs and adverse event terms. 3. Assess adverse event reports for seriousness, causality and expectedness as per the Investiga-tor Brochure/Basic Prescribing Information/US package insert, consulting the Medical Safety Expert whenever needed. 4. Determine the necessity for follow-up and prepare follow-up request as needed. 5. Work in conjunction with Clinical Safety Associates, Clinical Safety Scientists from other proc-essing sites and Medical Safety Physicians (Pharmacovigilance Leader and Brand Safety Leader) to ensure that reports are accurately evaluated and databased. 6. Triage literature cases for databasing or pass them on to the Team Leader for approval of re-jection. 7. Co-author, together with the Medical Safety Physicians, all required regulatory periodic re-ports, collecting, organizing and presenting the available data. 8. Work with external partner groups, e.g. co-licensing
Minimum requirements
PhD or PharmaD desirable Bachelors or Master degree in Life sciences or Pharmacy / Advanced Nursing as a minimum requirement English Relavant Experience in Slotted Corp Aff
Click here to apply directly
Wants to Learn Pharmacovigilance???? Click here
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