Oversee the vendor responsible for Case Intake, Medical Information and PQCs for generics and branded products.
Perform follow ups for ADEs to obtain additional information, where needed.
Log and document ADEs, MIs and PQCs per internal procedures to support the team as needed.
Forward cases to appropriate stakeholders as per SDEA/AEELs.
Reconciliation of ADEs, PQCs and MIs received, as needed.
Maintain electronic record and archives as per the defined procedures.
Compliance Monitoring for US FDA, SDEAs,
Assist RPP with audits and inspection-related requests and activities as necessary.
Perform subset of quality review/quality management of Individual Case Safety Reports (ICSRs).
Compile periodic reports in eCTD format for electronic submission to the FDA, and submission to FDA via ESG.
Provide root cause analysis (RCA) and CAPA for region IV late reporting, as applicable. Ensure procedural deviations are appropriately documented,
Ensure audit/inspection preparedness, manage regulatory, business partners and internal audits. Drafts any corrective action/preventative action plans (CAPA) as needed,
Manage and support Risk Management programs including review of associated documents and ensure compliance to the programs, as applicable. Participate in the development, implementation and maintenance of Risk Management programs and make decisions on behalf of Sun Pharma. Liaise with internal and external stakeholders, as required
Participate in internal audits and inspections by Agencies.
Education and Experience required:
Lifesciences degree, (atleast B-Pharm or PharmD)
Experience of minimum 4 years in Pharmacovigilance, and 3 year experience in people management
Strong knowledge for US FDA and Health Canada regulations
Strong organizational Skills
Strong Communication Skills
Flexibility to manage different time zones, as needed.