Hyderabad 0 - 5 years Full Time

Preferred Skills:

• Qualification: M.Sc. / B.Pharm / M.Pharm / B.Tech/M.Tech-Biotechnology
• Handling experience on ELISA and MSD
• Extensive experience on MD/MV of Ligand Binding Assays
• Well versed with bioanalytical, GLP regulations for handling bioanalytical projects

Job Description:

• Develop bioanalytical methods for PK, Immunogenicity and/or biomarkers in different biological matrices using LBA/ELISA techniques.
• Perform Method validation and sample analysis as per internal SOPs.
• Ensure activities conducted in the bioanalytical lab are in compliance with established SOPs, procedures, systems, regulatory guidance.
• Checking of data accuracy and integrity, data collation and report preparation.
• Regular interaction with QA (Quality Assurance) during data and reports review, closure of observations, reports sign off and archival.
• Ensure timely calibrations and maintenance of equipment.
• Reviewing of general documents, log-books, calibration records to ensure GLP compliance.

Tier I & Tier II cities 01 – 03 years Full Time

Department

Clinical Trials

Education Qualification

Any Science Graduate

Job type

At Clinical Trials site

Job Description

• Monitoring the trial throughout its duration, which involves visiting the study centres on a regular basis.
• Planning and ensuring the availability of allocated study specific requirements including resources, consumables etc.
• Ensuring the availability of all essential documents (prior to study initiation) for allocated studies
• Coordination for retention, sending back or destruction at the Pharmacy
• Review and supervision of TMF filing across the study duration.
• Supervision and ensuring of all study activities are to be carried out in compliance with in-house SOPs and approved protocol.
• Responsible for ensuring adequate quantity of IMPs to conduct clinical trial.
• Responsible to ensure IMP supplies, accountability and retention quantity at study centre.
• Designing data collection forms, known as case record forms (CRFs).
• Discussion on the process of obtaining informed consent form and documentation.
• Verifying the documentation of the informed consent process for each study subject.
• Verifying that data entered on to the CRFs is consistent with patient clinical notes, known as Source Data/Document Verification (SDV).
• Collecting completed CRFs from hospitals and general practices.
• Writing visit reports.
• Closing down study centres on completion of the trial.
• Archiving study documentation and correspondence.

Hyderabad 02 to 06 Years Full Time

• Plan and conduct investigator site selection audits and clinical trial study audits at investigator sites in accordance with applicable GCP guidelines and regulations.
• Review of subject ICF and medical records
• Review of CRF design
• Review of standard operating procedures
• Issue audit reports to the investigator site staff and other concerned study personnel
• Review and assess the audit responses/CAPA and closure of the audit report in a timely manner.
• Provide regular updates of non-compliance or major findings in clinical trials to the Head-Quality Assurance
• Review of Clinical study report
• Provide document review comments in a timely manner.

Hyderabad 3 to 5 years Full Time

Department

BA/BE & Clinical Trials

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

Hyderabad 7 to 9 years Full Time

Department

Clinical Trials

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

Hyderabad 2 to 6 years Full Time

Qualification: B.Pharm/ M.Pharm/ M.Sc

Roles and Responsibilities: 

• Plan, conduct BA/BE study audits (In process and Retrospective) in compliance with the protocol, SOPs and applicable GxP standards and regulations.
• Review of draft protocols, study ICFs and study CRF in line with applicable GxP standards and regulations.
• Review of eCTD and Clinical study report
• Provide document review comments in a timely manner.
• Issue audit reports to the auditee, review and assess the audit responses/CAPA and closure of the audit report in a timely manner.

Hyderabad 7 to 9 years Full Time

Department

Pharmacovigilance

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

Hyderabad 0 to 3 years Full Time

Department

Pharmacovigilance

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.

Hyderabad 3 to 5 years Full Time

Department

Pharmacovigilance

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.

Hyderabad 2 to 4 years Full Time

Department

Pharmacovigilance

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.