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Senior Drug Safety Associate
Hyderabad
2 to 4 years
Full Time
Department
Pharmacovigilance
Education Qualification
Graduate/Post Graduate/Doctorate degree in Life Sciences/Pharmacy/Medical Sciences or equivalent degree. Fluency in English.
Mode of work
On premise
Job Description
- Responsible for data entry of individual case safety reports into the safety database.
- Review and evaluate AE case information to determine required action based on and following internal policies and procedures
- Process all incoming cases in order to meet timelines
- Literature Search
- Full data entry including medical coding and safety narrative
- Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD)
- Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.
- Following up with sites regarding outstanding queries.
- Follow-up on reconciliation of discrepancies.
- Follow departmental AE workflow procedures.
- Closure and deletion of cases.
- Perform submission activities when trained and assigned.
- Understanding and application of good documentation.
- Perform any other drug safety related activities as assigned.
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Safety Writer – Aggregate Reporting (AR)
Hyderabad
3 to 5 years
Full Time
Department
Pharmacovigilance
Education Qualification
Graduate/Post Graduate/Doctorate degree in Life Sciences/Pharmacy/Medical Sciences or equivalent degree. Fluency in English.
Mode of work
On premise
Job Description
- Serves as Advity’s primary contact and expert for aggregate reports
- Interacts and communicates effectively internally and cross-functionally in a highly matrixed environment.
- Draft, Retrieve and analyse the safety data from global safety database and ensure adequate presentation in the ARs (PADER/PSUR/PEBRER/RMP/DSUR/ADco’s).
- Ensure a comprehensive and consistent aggregate analysis performed to establish the risk benefit profile of the product that meets all HA requirements.
- Alert the Medical Safety Physicians of potential safety issues and assist the Medical Safety Physicians in monitoring the safety profile of products.
- Support independent QC of ARs to ensure the information presented in AR is complete, consistent and compliant to regulatory and Advity standards. Adhere to good documentation practices to ensure audit/inspection readiness.
- Support projects related to operational excellence (including testing of safety systems/IT application) and process improvements according to internal and externals drivers.
- Review of literature articles to identify case safety reports.
- Responsible for operational Pharmacovigilance activities for assigned developmental and/or marketed products.
- Assist in signal generation and safety analysis activities.
- Support Health Authority inspections and audits, and development of Corrective & Preventative Actions (CAPA) to address safety findings.
- Responsible to be informed with the current global PV regulatory requirements.
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Drug Safety Associate – MICC
Hyderabad
0 to 3 years
Full Time
Department
Pharmacovigilance
Education Qualification
Graduate/Post Graduate/Doctorate degree in Life Sciences/Pharmacy/Medical Sciences or equivalent degree. Fluency in English.
Mode of work
On premise
Job Description
- To take responsibility for handling medical information inquiries in English and ideally one other language in which you are fluent.
- Receiving and answering calls from people requiring medical services or clarifications regarding a Medical Entity or Medical Device or Vaccines or Cosmetics.
- Understanding the requirements of the callers and provide precise information during Inbound/Outbound calls.
- Working quickly by multi-tasking and demonstrating the ability towards good customer service by providing the need full information on product
- Follow up calls if the adverse information is incomplete and getting in touch with the reporter/enquirer to obtain all the required information.
- To provide approved responses to medical inquiries from external customers including healthcare professionals and patients as well as assisting the pharmaceutical clients’ internal departments with queries where required. This includes acting as a call handling agent as part of the Medical
- Information dedicated call center.
- To prepare responses to inquiries based on research in the literature and collaboration with physicians both internally and with pharmaceutical client internal departments, if applicable.
- To participate in the out-of-hours provision of medical information for clients who have contracted a 24/7 inquiry handling service.
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Medical Writer
Hyderabad
3 to 5 years
Full Time
Department
BA/BE & Clinical Trials
Education Qualification
Graduate/Post Graduate/Doctorate degree in Life Sciences/Pharmacy/Medical Sciences or equivalent degree. Fluency in English.
Mode of work
On premise
Job Description
- Overall management and co-ordination of MW activities performed by the MW department.
- Interact cross-functionally with other departments (e.g. Clinical Operations, Medical Affairs, QA, PM) to ensure the timely completion of high quality deliverables.
- Ensure that all work done by the MW department is conducted in compliance with Advity.
- Research Policies, SOPs and relevant guidance’s and guidelines.
- Write and review protocols, ICFs and Clinical study reports for Phase I-IV studies (e.g. PK, FIM, BE/BA, safety), as needed.
- 5Set up and monitor assigned project timelines by maintaining department scheduling tools.
- Represent Advity in discussions with sponsors, at conferences and client meetings.
- Work with the Quality Assurance group in the development/revision and implementation of
- Standard Operating Procedures as required.
- Acquire and maintain knowledge of national and international guidelines.
- Participate in training sessions.
- Work in a safe manner that does not endanger yourself of co-workers.
- Execute other duties as may be required by management of Advity as training and experience allow
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Manager Business Development – Clinical Trials
Hyderabad
7 to 9 years
Full Time
Department
Clinical Trials
Education Qualification
MBA or Graduate/Post Graduate/Doctorate degree in Life Sciences/Pharmacy/Medical Sciences/B or equivalent degree. Fluency in English.
Mode of work
On premise
Job Description
- Drive sales (Identify business opportunities) of Clinical Trial business, and strategic pharma collaborations by generating new leads and prospects, prospecting qualified sales leads and leading new business development efforts.
- Planning and structuring clinical trials related sales activities
- Writing business, research and technical proposals
- Responding to RFPs/RFIs and Business Proposal requests.
- Participating in Bid defencing
- Managing corporate meetings, exhibitions and trade shows
- Negotiating client contracts, closing deals
- Maintaining strong relationships by: Providing support, information and guidance and recommending new opportunities
- Follow current market and technology trends to evaluate new potential markets
- Delivering on annual new business and revenue plans
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Manager Business Development – Pharmacovigilance
Hyderabad
7 to 9 years
Full Time
Department
Pharmacovigilance
Education Qualification
MBA or Graduate/Post Graduate/Doctorate degree in Life Sciences/Pharmacy/Medical Sciences/B or equivalent degree. Fluency in English.
Mode of work
On premise
Job Description
- Drive sales (Identify business opportunities) of Clinical Trial business, and strategic pharma collaborations by generating new leads and prospects, prospecting qualified sales leads and leading new business development efforts.
- Planning and structuring clinical trials related sales activities
- Writing business, research and technical proposals
- Responding to RFPs/RFIs and Business Proposal requests.
- Participating in Bid defencing
- Managing corporate meetings, exhibitions and trade shows
- Negotiating client contracts, closing deals
- Maintaining strong relationships by: Providing support, information and guidance and recommending new opportunities
- Follow current market and technology trends to evaluate new potential markets
- Delivering on annual new business and revenue plans
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