Senior Pharmacovigilance Specialist

Job Description

The Senior Specialist, PV is responsible for specified PV activities (as delegated or assigned by their manager) and is able to work on these activities independently. The Senior Specialist, PV is responsible for ensuring adherence to all applicable regulations, company policies and procedures.

The Sr. 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 the 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”.

• 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.

• Responsible for day-to-day adverse events case management which may include case intake, translations (to English and/or local language (as applicable)), acknowledgments, follow-up and submission activities in accordance with PV procedures and country regulations.

• Participates in and supports local PV, business partner and vendor audits and inspections including readiness activities and the development of CAPAs in response to findings/observations

• Participates in issue management/compliance activities and coordinates the preparation of necessary local corrective actions.

• Assists in developing and maintaining local PV procedures and controlled documents in compliance with local, regional and global standards, to ensure global quality PV data.  Documents may include but are not limited to standard operating procedures, other procedural documents, training materials, controlled Pharmacovigilance Documents e.g. Company Core Pharmacovigilance Document.
• Conducts and/or supports PV self-inspections as required by PV Legislations (where applicable).
• Prepare/maintain/submit local RMPs to the local HA (as applicable).

• Responsible for ensuring appropriate implementation and oversight of Risk Minimization Measures, and Additional Risk Minimization Measures locally as per local procedure and ensures compliance with local legislation.

• Responsible for managing and performing local literature screening and assessment in accordance with company procedure and local requirements (as applicable)

• Support local implementation of applicable business continuity plans.
• Responsible for filing, storage and archiving safety-related documentation in accordance with company’s policies and local requirements.
• May serves as a local SME on relevant PV regulations, processes and procedures.

• May coordinate and/or completes translation of applicable PV documents and ensures a QC check is performed by a second person for any in-house translations.

• Supports PV Lead in maintaining the local PV Training matrix and onboarding plans.

• 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.

• 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)

• Liaises with the local business units to keep them apprised of safety activities and provides input on strategic decisions.
• Represents PV in cross-functional organizational and alliance partner forums as needed.
• Participates on local company committees and councils for matters impacting PV as assigned.
• Participate in PV engagement in relevant external associations/industry forums, and regulatory authorities, as applicable.
• May be responsible for management of one or more direct reports including recruitment, training, development, and performance management as applicable.
• Participates in special projects or rotational assignments within or outside of IPV as part of their professional development.
• Responsible for completing all required/applicable trainings assigned at time of hire and after hire, by the due dates and before performing the activity.

When serving as back-up of the PV Lead in PV Lead absence performs the following key activities: 

• Serves as local subject matter expert on relevant PV regulations, processes and procedures and ensures compliance.

• 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

• Fulfills procedural tasks of the PV Lead unless otherwise delegated.

• Reports or escalates potential safety or security issues.

• Liaises with local business units to contribute to strategic decisions that impact PV.

0-5%

• Health, life science, or medical science degree or equivalent by education/experience (Hiring Manager discretion permitted).

• At least 2 years of experience in the pharmaceutical industry is preferred (Hiring Manager discretion permitted).
• Supervisory experience managing people/teams/contractors is preferred if the position will be managing staff (Hiring Manager discretion permitted).
• In-depth knowledge of AE reporting requirements and relevant PV regulations, PV quality management systems and be an expert in PV processes and activities.

• Experience with PV audits and/or PV Health Authority Inspections.

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