Candidate will perform the following activities on behalf of the Marketing Authorization Holder.
Main responsibilities will include:
Maintaining oversight of the PV system in all relevant aspects including:
SOPs & Training
Databases (awareness of validation status of the database, changes in database and need for revalidation)
Compliance data regarding quality
Audit/inspection plans and Corrective Actions Preventative Actions
PV systems of local affiliates
Ensuring that all PV processes are conducted in accordance with pertinent regulations.
Overseeing preparation and maintenance of PV System Master File.
Maintaining an overview of safety profiles and any emerging safety concerns of all Marketing Authorization Holder products.
Signal management process to identify possible safety signals on Marketing Authorization Holder products.
Ensuring awareness and appropriate fulfillment of CA queries and commitments.
Development of Risk Management Plans.
Development of Periodic Safety Update Report (PSUR).
Have input to the risk based audit of PV system is performed at pre-defined intervals and if justified instigate an audit for cause.
Managing members of the QPPV Office
Carrying out continuous overall pharmacovigilance evaluation of the drug post marketing
To perform literature surveillance activity for all Marketing Authorization Holder products
Vendor management for pharmacovigilance related work
Salary: As per company norms
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical , Healthcare , R&D , Pharmaceuticals , Biotechnology
Role Category: Drug Regulatory Affairs/Documentation
Role: Documentation/Medical Writing as an Intern
Employment Type: Intern to Hire
Qualification: Any Life Science graduate
Interested people can forward their profile to email@example.com or for any guidance reach us on +91-9848733309/+91-9676828080