Pharmacovigilance Associate

1 week ago


Ameerpet Hyderabad Telangana, India Gratisol Labs Full time

Perform triage & intake of ICSR received daily in ARGUS databases within the agreed timelines

Monitor and download ICSRs from Eudravigilance (EV) for valid ICSRs

Processing literature, spontaneous as well as clinical trial and solicited cases

Schedule and perform search of literature reports for valid ICSR in PubMed and MLM

Responsible for generation of reports and submission to health authority and business partners

Ensure data entry of serious and non-serious ICSRs (Spontaneous, Solicited and literature) in ARGUS as per client SOP and WI with high level of data accuracy

Responsible for coding events, indications and patient history based on MEDDRA

Coding of suspect products as well as concomitant., Amending the narrative when required, Performing Labeling of events

Responsible to obtain follow-up information for all serious and non-serious cases as per the guideline on Good Pharmacovigilance Practices (EU-GVP).

Perform the submission of the processed cases to regulatory authority and report distribution to Partner.

Communicate and interact effectively within and across all client key stakeholders and within internal team management as appropriate

Attend all the internal trainings and client trainings and ensure compliance with applicable guidelines

Track and perform daily and monthly reconciliation of ICSRs as per client requirements

**Job Types**: Full-time, Fresher

Pay: ₹225,000.00 - ₹400,000.00 per year

Schedule:

- Day shift

Work Location: In person



  • Ameerpet, Hyderabad, Telangana, India FORWARD LIFE PVT Full time ₹ 10,40,000 - ₹ 26,40,000 per year

    Job Title: Pharmacovigilance Associate / Drug Safety AssociateLocation: AmeerpetDepartment: Pharmacovigilance / Drug SafetyReports To: PV Manager / Head of PharmacovigilanceJob Purpose:To ensure patient safety by monitoring, collecting, assessing, and reporting adverse drug reactions (ADRs) and other safety information in compliance with global...


  • Hyderabad, Telangana, India Bristol-Myers Squibb Full time

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...


  • Hyderabad, Telangana, India Clininfotech Full time ₹ 8,00,000 - ₹ 12,00,000 per year

    Job OverviewThe Executive Pharmacovigilance will be responsible end-to-end case management, including case receipt, case follow-up,database entry, review and submission to applicable regulatory authorities within stipulated timelines. Required Candidate profileAny Pharmacy or Pharm D with Certification in Pharmacovigilance can ApplyShould have Good...


  • Hyderabad, Telangana, India Novartis Full time

    **Summary**: Supports ESP Engagements team in supervision and oversight of pharmacovigilance activities outsourced to External Service Providers (ESPs). Supports ESP Engagements team in ensuring appropriate governance of ESPs and support to communicate and implement ESP strategies. **About the Role**: **Major accountabilities**: - **Support**Associate...


  • Hyderabad, Telangana, India Amgen Inc Full time

    Job Description- Support interactions with business partners (license partners) and vendors for all case intake and processing activities.- Vendor oversight of all case intake and processing activities and case quality including analysis and reporting of trends in quality measures.- Ensure vendor compliance with approved processes and training requirements.-...


  • Hyderabad, Telangana, India Amgen Inc Full time

    Job DescriptionKey Activities- Work within the Quality Management System framework including all applicable training and controlled documentation governing Pharmacovigilance processes.- Triage of initial data entry (book-in) of new PC, AE and OSF cases is complete.- Performs the initial book-in activities and appends additional information or documents to...

  • Associate - Projects

    2 weeks ago


    Hyderabad, Telangana, India Cognizant Full time

    **Functional Lead** **Qualification**: Masters in Business Administration ** Responsibility**: **Requirement Gathering and Gap Analysis**: - Understand business requirements through business workshops, one on one interviews. - Analyze business requirement document. - Analyze gaps in order to meet business requirements. **Solution Engineering**: -...


  • Hyderabad, India Clininfotech Full time

    Perform triage & intake of ICSR received daily in ARGUS databasesShould have hands On Experience On ARGUS Safety DatabaseShould Have hands on Experience on MEDDRAApplicants Should Complete Certification in Pharmacoviiglance Required Candidate profile B.Pharm / M.Pharm/Pharm D/Life sciences degree With Hands On Experience On Argus Safety Database and Med...


  • Hyderabad, Telangana, India Novartis Full time

    Summary The Coding and Dictionary Management Lead provides effective leadership and guidance to the team members creates a positive and collaborative work environment and ensures the Patient Safety Pharmacovigilance mission of proactive thorough accurate safety signal detection MedDRA query management and compliance with regulatory requirements ...

  • Associate Director

    2 days ago


    Hyderabad, Telangana, India Novartis Full time

    Summary Location Hyderabad In this role he will drive a strategic AI transformation across the pharmaceutical value chain from drug discovery to commercialization by leading enterprise-wide initiatives and coaching sub-ordinates to deliver high-impact solutions Major Accountabilities Domain Expertise Serve as a strategic expert in life sciences ...