• This role will act as Local Pharmacovigilance Officer (LPSO) for activities in the territory and act as back-up LPSOs for other team members as assigned.
• This role is responsible to support Pharmacovigilance Officer In charge – PvOI (India Cluster lead) to managed Safety information, case processing, archiving, submissions and other operational activities, in compliance with the national regulations and the client's PV procedures for drugs and biologics.
• Support the Pharmacovigilance Officer In charge – PvOI (India Cluster lead) to implement and ensure compliance to the client Pharmacovigilance (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 client's policies/ procedures at a local, regional and global level. The territory covered by this role are- India, Bhutan, Nepal, Bangladesh and Sri Lanka.
• Maintain a thorough understanding of and comply with the client Pharmacovigilance 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 client Pharmacovigilance 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, client employees (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
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.