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Lambda Therapeutic Research job vacancy for Medical Reviewer- Aggregate Reporting || Apply Now
Lambda Therapeutic Research is a full-service Global Clinical Research Organization (CRO) with its headquarters in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Warsaw (Poland), London (UK), Toronto (Canada), Pittsburgh (USA), and Las Vegas (USA), we offer comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries.
Experience required: 0- 5 Years
3 Vacancies
Salary: ₹ 8-17 Lacs P.A
Job location: Ahmedabad
Job Responsibilities:
1. To ensure pharmacovigilance activities within Lambda are carried out in accordance with all SOPs, relevant regulations and guidelines.
2. To ensure the provision of appropriate pharmacovigilance advice to clients and colleagues.
3. To provide support and medical leadership for the assessment of all pharmacovigilance activities throughout the department.
4. Contributing to the on-going enhancement of Pharmacovigilance processes and prepare, revise, review of standard operating procedures, work instructions, templates, guide and guidance training documents.
5. To provide support to other members of the pharmacovigilance team as required and to assist less experienced team members to enable them to fulfil their roles. Deliver training to new joinee and team as per requirement and provide back-up medical support on products/projects where required.
6. Regulatory Intelligence: Awareness of changes to and implementation of relevant regulations.
7. Medical assessment of the safety profile of the client’s product range.
8. Provide guidance and participation in the follow-up of Adverse Events.
9. Responsibility for evaluation of Adverse Events and provide causality. Review of data entry, Drug coding, MedDRA coding and listedness. Assessment for expediting and narrative review of ICSR in accordance with Companys controlled documents (e.g. SOPs, WIs, Guide) relevant regulations and guidelines.
10. Ensure communication with all relevant people is of a high professional standard, and that records of both internal and external communication are maintained.
11. Ensuring compliance (quality, procedures, regulations, timeliness, consistency) with local regulations and Company’s global Pharmacovigilance requirements.
12. Work with the group leader to escalate issues or tasks outside the normal scope of work.
13. Support group leader for timely submission of ICSR to achieve 100% regulatory compliance.
14. Knowledge of local and national requirements for pharmacovigilance requirements and interact with staff at various levels and in various functional areas to resolve any issues that arise during reviews.
15. Providing input into responses to inquiries from regulatory authorities or health care professionals on safety issues.
16. Any other tasks as requested as by line manager to meet business requirements.
17. Responsible for medical review and approval of Aggregate reports [including but not limited to Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Addendum to Clinical Overview (ACOS)] required by global regulatory agencies for review of safety information when authorised to perform this function on behalf of client.
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