Quality Assurance Analyst Junior 0-2yrs Job in Rangam Infotech Pvt. Ltd.

Job Summary Job Description

Description:

Title will be : PV associate. Due to system limitation QA title selected.
This position is backfill for Anju Sukumaran.
Title will be : PV associate. Due to system limitation QA title selected.
-Adverse events due diligence and follow up.
-Case intake process in Pharmacovigilance Safety System (PSS) - understand adverse event report process in PV database and register accurately cases in PSS within timeline in accordance with client's procedure and regulatory requirements.
-Respond to queries from country PV and/or Global PV and its service provider.
Other duties, tasks or projects as assigned.

Job Description

Job Title: PV Associate

Department: Pharmacovigilance

Function: Global Pharmacovigilance

Summary

This role is responsible to support Pharmacovigilance Officer In charge (PvOI) to managed Safety information, case processing, archiving, submissions and other operational activities, in compliance with the national regulations and clientPV procedures for drugs and biologics.

Support the PvOI to implement and ensure compliance to the clientPharmacovigilance (PV) system for medicinal products and biologics in the assigned countries (Territory), in compliance with the local national regulations/ standards; Global PV legislation/ standards; and clientpolicies/ procedures at a local, regional and global level. The territory covered by this role are- India, Nepal, Bhutan, Bangladesh and Sri Lanka.

Maintain a thorough understanding of and comply with the clientPharmacovigilance Quality systems and policies.

To update all safety information at a local level in the Global Pharmacovigilance safety database and submit to regulatory authorities as per regulatory requirements, within reporting timelines.

Essential Duties and Responsibilities.

o PV Quality Systems:

o To comply with the clientPharmacovigilance Quality systems and policies.

o Ensure compliance with procedures for document management retention and archiving.

o Ensure all training requirements for the role are met.

o Ensure adherence to the BCP (Business Continuity Plan).

o With regards to third party agreements:

Perform due diligence.

Perform reconciliation of data between the third party and client.

o Case Intake:

o Manage the receipt and capture process for adverse event (AE) and pregnancy report collection in the Pharmacovigilance safety database.

o Various sources of AEs include but are not limited to; spontaneously reported cases from patients, HCP, nurses, clientemployees (including AEs associated with product complaints and AEs associated with medical queries), social media reports, partner companies and regulatory authorities; and solicited cases from patient support programs, market research programs, clinical studies and call centers.

o Assess the need for utilizing appropriate forms and questionnaires, complete appropriate forms and capture the information in the Pharmacovigilance safety database.

o Perform the initial assessment on case validity, check for core case elements, perform duplicate checks and request for case deletion as required.

o Perform a seriousness assessment and assess expectedness against the local

label.

o Perform translation of source documents and local quality check of translation as required. Ensure all source documents are captured in the Pharmacovigilance safety database.

o Determine the requirement for follow up information and collect as much information related to a particular ICSR. Manage the process for collection and handling queries from the Global team.

o Re-assess the follow up information in the context of case validity, seriousness and expectedness; capture all follow up information and source documents in the Pharmacovigilance safety database.

o Perform ongoing tracking and local quality check of AE cases for follow up and submission requirements.

o Manage patient identified batch review requests as required.

o At adverse event case receipt, analyze for safety information that requires immediate forwarding to Drug Safety Physician.

o Perform reconciliation activities for AE cases as required, e.g., with third parties, call centers.

o Regulatory Submissions:

o Maintain expert knowledge of the local regulatory reporting requirements.

o Manage the process for expedited submission of AEs to local authorities. Track submissions in the Pharmacovigilance safety database and archive all submission records. Perform manual and electronic submissions, as per local regulatory requirements.

o Respond to submission related queries from the local regulatory authorities and archive all regulatory related correspondence.

o Safety Risk Management Activities:

o Support Qualified Officer In charge with Implementing risk minimization measures locally as appropriate.

o Perform surveillance activities for any new potential safety information (e.g. similar AEs reported in a cluster of reports or multiple cases for one batch received in a short time frame) and escalate as per procedures

o Other Responsibilities:

o Escalation of requests, received directly by local PV contact or indirectly (by Country RA /Country QA) from Regulatory Authorities relating to product safety, efficacy and quality must be disseminated to Qualified Officer In charge.

Update the PvOI in charge of all pharmacovigilance activities and safety issues.

Qualifications. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.

N/A: Intern or Co-op

Good communication skills with fluency in English verbal and written.

Knowledge of Microsoft tools Word, Excel and Power point.

• Ability to work well as an individual contributor and in collaboration with team.

• Strong collaboration skills and high learning agility.
• Should be able to work in in persona and virtual set up.

Education and/or Experience. Include the education and/or experience that is necessary to perform the job satisfactorily.

N/A: Intern or Co-op

• Degree in Medical Discipline e.g. Pharmacy, MBBS/ BDS, B. Tech Biotec, Bsc/ Msc in Science field.