Dir., Drug Safety

**Position : Director - Drug Safety,**Pharmacovigilance**

The Director, PV is responsible for adverse event management including aggregate and individual case safety report (ICSR) health authority submissions and for ensuring compliance with PV processes and regulations, company policies and procedures, and establishing & maintaining best practices. They are also responsible for managing and developing PV staff and for other activities as delegated by the PV Lead which may include but are not limited to management and negotiation of local PV agreements, local due diligence activities, participation in audits and inspections and related readiness activities, review of local initiatives for compliance with PV requirements, SOP management, local training, communication of safety issues.

The Director, PV may serve as the Back-up (BU) local Qualified Person for PV (QPPV) / BU Local PV Contact / BU Local Responsible PV person as required per local PV legislation. In the absence of the PV Lead, they serve as their back-up.

**The items listed below are activities that can be performed by the role and is applicable for all supported countries. Specific details of tasks and responsibilities of the local QPPV, Local PV Contact / Local Responsible PV Person** role**and Country PV staff may be further described in the section below entitled “Additional Local Specific Activities”.**
- Serves as the point of contact for the local Health Authority for PV related questions when assigned by the PV Lead and in their absence.
- If serving as the local QPPV / Local PV Contact / Local Responsible PV Person or Backup, complies with all requirements mentioned in the local laws and regulations.
- May be responsible for management of one or more direct reports including recruitment, training, development, and performance management as applicable.
- Oversees and responsible for execution of local PV processes and activities in collaboration with internal functional areas and external parties as assigned. May coordinate translation of PV documents and ensure a QC check is performed by a second person for any in-house translations (as applicable).
- Serves as a SME and supports local PV audits and inspections including readiness activities and supports other audits/inspections including the development of CAPAs in response to findings/observations.
- Participates in and supports audits of contractual partners/vendors as necessary.
- Participates in compliance activities and coordinates the preparation of necessary corrective actions locally for late reporting countries covered by the country operation.
- Develops and maintains local procedures (in compliance with regional and global standards), to ensure global quality PV data and evaluates processes for potential improvement in efficiency and effectiveness.
- Supports PV Lead in maintaining the local PV Training matrix and onboarding plans as assigned. Supports the development and maintenance of local PV controlled documents (e.g.,
- Company Core Pharmacovigilance Documents, training materials, etc. as applicable) ensuring that they are kept current.
- Conducts and/or supports PV self-inspections as required by PV Legislations (where applicable).
- Proactively identifies procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders.
- Responsible for completing all required/applicable trainings assigned at time of hire and after hire by the due dates, before performing the activity. Supports training of local company staff, distributors, vendors, and business partners and can provide training as applicable.
- Responsible for managing and performing local literature screening and assessment in accordance with company procedure and local requirements (as applicable).
- May be responsible for Health Authority Website Monitoring for potential safety issues, safety alerts, and new/revised PV requirements in compliance with company procedures and local legislation (as applicable).
- May be assigned responsibility for ensuring appropriate PV language is included in country PV agreements, liaising with business partners, vendors and Alliance Managers as required, performing local qualification/due diligence activities, compliance reviews, and ensuring maintenance of the business partner data tracking system.
- As delegated by PV Lead, collaborates with internal stakeholders to ensure local implementation of Post approval Safety Monitoring Program (PSMP) plan in compliance with local legislation (as applicable).
- May be responsible for reviewing, providing input and approving local initiatives (e.g., digital interfaces, marketing initiatives/ patient programs, organized data collection systems, etc.), and other programs to ensure compliance with PV requirements, as applicable.
- As assigned by PV Lead, responsible for scheduling and coordinating submission activities for PSURs and other Aggregate Reports to the local Health Authority in compliance