Hyderabad 0 to 2 Years Full Time

Education Qualification: MBA

Desired Skills: 

• Good communication skills
• Good written skills
• Good to have knowledge in MS-Office

Roles and Responsibilities: -

• Job Postings on social media and job boards
• Sourcing profiles, Screening profiles, Schedule Interviews, candidate follow-up and Status updates on a regular basis
• Handle onboarding formalities and initial induction to newly hired employees
• Compile and update employee records (hard and soft copies)
• Day to Day HR activities

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 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

Hyderabad 2- 4 years of relevant experience (M.Sc. (Biochemistry/Microbiology/Biotechnology) /M. Pharm/ B. Tech (Biotechnology)) Full Time

• Development and validation of ELISA methods as per regulatory bioanalytical method validation guidelines (EMEA, USFDA and ICH) for Pharmacokinetic (PK)/ pharmacodynamic (PD) and Immunogenicity (ADA) assessment.
• Responsible to perform study sample analysis by ELISA in compliance with applicable methods, protocols, SOPs, and regulatory guidelines.
• Procurement and preparation of kits, antibodies and reagents.
• Operation, calibration and maintenance of bioanalytical equipment
• Responsible for coordinating and working with the project team for timely completion of assigned project
• Preparation of Standard Operating Procedures (SOPs), Bioanalytical project reports.

Hyderabad 2 to 6 years Full Time

Education 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 2-6 Years Full Time

Educational Qualification: B.Pharm/ M.Pharm/ M.Sc

Roles & Responsibilities: 

• Plan, conduct BA/BE study audits (In process and Retrospective) in compliance with a study plan, protocol, SOPs and applicable GxP standards/regulations.
• Review of Method Development and Method Validation data
• Review of draft Method SOPs and Bioanalytical study plan in line with applicable SOPs and GxP standards/regulations
• Review of eCTD and Bioanalytical 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

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

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.

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.

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.