Sr. Manager – Reg. Affairs

  Pharmacovigilance

Job title: Sr. Manager – Reg. Affairs

Company: Genpact

Job description: With a startup spirit and 90,000+ curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it. Now, we’re calling all you rule-breakers and risk-takers who see the world differently, and are bold enough to reinvent it. Come, transform with us.
Are you the one we are looking for?
We are inviting applications for the role of Manager or Senior Manager, Pharmacovigilance (PV) Regulatory affairs.
Responsibilities:

  • Ensures effective functioning of all PV projects in compliance with client agreement, contract; and local and global regulatory guidelines.
  • Monitor and process data generated by social media and other online sources for pharmacovigilance (PV) information related to client. Also, identification of adverse events (AEs) and product quality complaints (PQCs), translation of relevant data into English, coding potential safety data to MedDRA terminology, sorting data into safety categories, expediting valid AE/PQC cases to client, and recording non-valid AE cases in an external Dashboard for Client safety evaluation.
  • Following up with patients and healthcare providers to get the full clinical picture of possible adverse drug events
  • Categorization of PV data captured from social media sources valid AE, non-valid AE and product quality complaint (PQC), and will be recorded as follows:
  • Non-valid adverse events (AEs) captured in a customizable Dashboard
  • Reporting of Valid AEs and PQCs as per agreed timeline
  • Provide accurate and timely responses to medical information queries
  • Provide medical writing and literature surveillance for the client as per established process
  • Processing Individual Case Study Reports (ICSRs) from a variety of sources including literature reports, health authority reports (e.g.ASPRs) and spontaneous reports
  • Carrying out ICSR local reporting
  • Reviewing data entry of ICSRs onto a safety database and MeDRA coding
  • Providing guidance on PSMF (Pharmacovigilance Safety Master File) administrator activities and case processing, quality review of PADERs and line listing
  • Responsible for quality management, workload management, compliance management and document management across all PV projects.
  • Deliver on agreed SLAs with clients at contract and account/ project level. Meet all monthly reporting/business metrics/KPIs requirements, client meetings and manage internal control processes.
  • Planning the project by understanding the client needs, channelizing appropriate resources, managing project deliverables and providing solutions in real time.
  • Ensure established policies and procedures of the organization/client are followed and ensure compliance.
  • Work with cross-functional teams.
  • Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
  • Demonstrated understanding of related fields
  • Demonstrated ability to generate innovative solutions to problems and effectively collaborate with and communicate to key stakeholders.
  • Demonstrated flexibility in responding to changing priorities, multi-tasking and dealing with unexpected events.
  • Demonstrated effective leadership, communication, and interpersonal skills.

Qualifications we seek in you!
Bachelor’s or master’s degree required in science, or related field (advanced degree preferred).
Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values diversity and inclusion, respect and integrity, customer focus, and innovation. For more information, visit www.genpact.com. Follow us on Twitter, Facebook, LinkedIn, and YouTube.

Expected salary:

Location: Mumbai, Maharashtra

Job date: Fri, 22 Apr 2022 03:50:05 GMT

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