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Patient Oriented Programs Manager

3 weeks ago

Hyderabad Secunderabad Telangana, India beBeeRegulatory Full time
Job Description

We are seeking an experienced professional to manage the end-to-end Patient Oriented Programs (POP) process in accordance with Doing Business Ethically (DBE) policy and POP Standard Operating Procedures (SOP). The ideal candidate will have a strong understanding of local regulatory requirements and applicable policies surrounding the pharmaceutical industry.

The successful candidate will be responsible for coordinating with all POP stakeholders, including POP Champion/ Procurement/ Legal/ Patient Safety/ Compliance/Quality Assurance, and creating POP documents. They will also be responsible for obtaining necessary approvals for conduct of POP in a timely manner and ensuring overall management of External Service Providers (ESP) compliance check prior to fieldwork initiation.

The selected candidate will be required to enter program details in the POPsys database throughout the conduct of the POP, keeping track of all required activities related to POP conduct and ensuring no monitoring gaps before program closure in POPsys. Additionally, they will maintain documentation for all POP related activities in the POP repository and ensure identified quality issues are well documented in the quality issue management tool.

The job requires effective management of all projects assigned, timely escalation of findings related to projects, and constant feedback from stakeholders to improve on suggestions put forth. A good understanding of pharma compliance or commercial framework is essential, and experience in the pharmaceutical industry within Clinical, Pharmacovigilance (PV), Medical/regulatory Affairs is highly desirable.

Required Skills and Qualifications
  • Preferrable experience with 2-5 years experience in the pharmaceutical industry within Clinical, Pharmacovigilance (PV), Medical/regulatory Affairs, or relevant experience in pharma compliance or commercial framework.
  • Good understanding of local regulatory requirements and applicable policies surrounding pharmaceutical industry.
  • Ability to communicate effectively across different audiences, organizational levels and local and global teams.
Benefits

A college/university degree, preferably in security, criminal justice, crisis management, business continuity or other related field, is highly desirable. An advanced degree is highly desirable (e.g., Master's degree or MBA).