Drug Safety Specialist

Job Description

The Specialist PV is responsible for specified PV activities (as delegated/assigned by their manager) and is able to perform these tasks with minimal supervision. The Specialist PV is responsible for ensuring adherence to all applicable regulations company policies and procedures.

The Specialist PV may be designated by the PV lead to 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. When designated in the absence of the PV Lead they may manage day-to-day PV activities and serve as their back-up with supervision by a higher-level manager as required.

The items listed below are activities that can be performed by the role as assigned by the manager and are applicable for all supported countries. Additional local specific tasks and responsibilities may be further described in the section below entitled Additional Local Specific Activities.

1. Responsible for execution of local PV processes and activities in collaboration with applicable internal functional areas and external parties ensuring alignment with local legislation and local/regional/global company procedures and policies. Activities may include but are not limited to management and negotiation of local PV agreements local due diligence activities Post approval Safety Monitoring Program (PSMP) implementation scheduling and coordinating aggregate safety report submissions conducting local training review of local initiatives for compliance with PV requirements communication of safety issues.
2. Responsible for day-to-day adverse events case management which may include case intake translations (English and/or local language (as applicable)) acknowledgments follow-up and submission activities in accordance with PV procedures and country regulations.
3. Supports local PV business partner and vendor audits and inspections including readiness activities document requests and CAPA activities.
4. Participates in issue management/compliance activities and coordinates / prepares the necessary local corrective actions.
5. Supports development and maintenance of local PV procedures and controlled documents in compliance with local regional and global standards to ensure global quality PV data.
6. Supports PV self-inspections as required by PV Legislations (where applicable).
7. May be assigned responsibility for ensuring appropriate implementation and oversight of Risk Minimization Measures and Additional Risk Minimization Measures locally as per department policy and local legislations.
8. Prepare/maintain/submit local RMPs to the local HA (as applicable).
9. May be responsible for managing and performing local literature screening and assessment in accordance with company procedure and local requirements (as applicable).
10. Support local implementation of applicable business continuity plans
11. Responsible for filing storage and archiving of safety-related documentation in accordance with company policies and local requirements.
12. Serves as local Subject Matter Expert on relevant PV regulations processes and procedures.
13. Translates or QCs translation of applicable PV documents.
14. Supports PV Lead in maintaining the local PV Training matrix and onboarding plans.
15. 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
16. 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).
17. Liaises with the local business units to keep them apprised of safety activities and provides input on strategic decisions.
18. Represents PV in cross-functional organizational and alliance partner forums as needed.
19. Participates on local company committees and councils for matters impacting PV as assigned.
20. Participates in special projects or rotational assignments within or outside of IPV as part of their professional development.
21. Responsible for completing all required/applicable trainings assigned at time of hire and after hire by the due dates and before performing the activity.

The PV Specialist might act as the deputy QPPV for Egypt and back up for PV responsible person for Libya Sudan and Yemen.

When serving as back-up of the PV Lead in PV Lead absence performs the following key activities:
1. Comply with all requirements mentioned in the local laws and regulations.
2. Serves as local subject matter expert on relevant PV regulations processes and procedures and ensures compliance.
3. Serves as the point of contact for local Health Authorities and liaises with Regulatory Affairs Medical Affairs Clinical Research and other functional areas for Health Authority questions regarding PV
4. Fulfills procedural tasks of the PV Lead unless otherwise delegated.
5. Reports or escalates potential safety or security issues.
6. Liaises with local business units to contribute to strategic decisions that impact PV.

Qualifications and Experience:

• holding a Pharmacy or Medical degree.
• be fluent in English (written and spoken) while proficient in Arabic local language.
• 2 years of industry experience with priority for at least 1 Year of PV experience.
• Local with good pharmacovigilance guidelines experience is a must.
• PV Experience with Libya Sudan and Yemen is a plus.

Skills:

• Strong communication skills
• Time Management skills
• Collaboration and Partnering
• Problem Solving

Required Skills:

Preferred Skills:

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Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

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