Dr. Reddy’s Laboratories Released Job Openings On 20/09/2022. Dr. Reddy€™s Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Application form link provided at the end of post.
Dr. Reddy’s Laboratories Recruiting Master in Science, with minimum 8 years Experience for Pharmacovigilance Specialist Position.Complete Details for the Pharmacovigilance Specialist as follows.
Important Details :
- Job Location: Hyderabad
- No of Vacancies:NA
- Salary: NA
- Details of Salary:NA
- Opening date for online Application:20/09/2022
- Mode of application :Online
- How To Apply: At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
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Job Description/Skills Required
- Provide pharmacovigilance inputs for study documents as per request on operational aspects for SAE management. Ensure the documents are reviewed by the Medical Assessment team as required.
- Develop or review/approve (if written by CRO) safety management plan, global SAE and DSUR reporting plan, relevant forms and other relevant documents.
- Coordinate with Safety Database Manager to ensure database set-up is performed for CPD and protocol configuration. For outsourced study ensure that CRO’s database is set-up as per set standards.
- Oversight of AE/SAE intake, allocation of cases to vendor to ensure all the AE/SAE reports are processed on time as per agreed quality standards.
- Perform sponsor quality review of SAE reports for clinical trials, action the review of and approval of the SAE/SUSAR reports by DRL’s safety physician and provide sponsor approval to PV vendor/CRO.
- Ensuring that PV vendor has most current and effective investigator brochure for expectedness assessment.
- Ensuring designated team members including safety physician of PV vendor are trained on study protocol.
- Monitor that all the expeditable SAE reports (SUSARs) are submitted to relevant Health Authorities including other participating investigators and ethics committees, on time successfully.
- Participate in internal and external study project team meetings and act as single point of contact for all matters related to AE/SAE management. Perform sponsor review of safety content included in training material to be used to train site staff during SIV site initiation visits (SIV) and investigator meeting (IM).
- Oversight of periodic SAE reconciliation activities.
- Managing all the queries including issues raised by sites, clinical operations team, study DM team and other relevant stakeholders on end to end SAE management.
- Coordinate for adequate response development for all Health Authority queries on SAE reports in association with Head PV Operations, CRO/PV vendor and study team.
- Review, revision and authoring of relevant documented procedures (SOP, WI, Manual etc.) related to clinical study case processing and quality check as and when required.
- Liaison with relevant cross functional teams (e.g. RA, DRL affiliates) to set-up AE/SAE reporting mechanism for global study.
- Generation of periodic monthly case volume and compliance matrices and sharing with Lead- PMS Case Processing for inclusion in periodic management report and monthly compliance meeting, as applicable.
- Prepare monthly report of various studies detailing their status, no of AEs/SAEs, overall compliance and report to Head PV Operations.