Senior Pharmacovigilance Specialist
4 weeks ago
The Senior Specialist, PV is responsible for adverse event management including aggregate and individual case safety report (ICSR) health authority submissions and compliance monitoring. They are also responsible for PV activities (as delegated or assignedby their Manager) which may include but are not limited to: PV intake, management and negotiation of local PV agreements, local due diligence activities, participation in audits and inspections and related readiness activities, review of local initiativesfor compliance with PV requirements, SOP management, local training, communication of safety issues, people development, special projects as assigned and is able to work on these delegated activities independently.
**The items listed below are activities that can be performed by the role**
- Responsible for execution of local PV processes and activities in collaboration with internal functional areas and external parties as assigned.
- Serves as 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.
- Responsible for reporting adverse experiences or events (AE) or product quality complaints (PQCs)
- 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.
- Assists in developing and maintaining 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
- Conducts and/or supports PV self-inspections as required by PV Legislations
- Proactively identifies procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders.
- Responsible for completing all required/applicable training
- Supports training of local company staff, distributors, vendors, and business partners and can provide training 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.
- May be responsible for reviewing, providing input and approving local initiatives
- 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 with company procedures and local legislation (as applicable).
- As assigned by PV Lead, responsible for ensuring appropriate implementation and oversight of Risk Minimization Measures, and Additional Risk Minimization Measures locally as per department policy and ensures compliance with local legislations.
- As assigned by PV Lead, prepare/maintain/submit local RMPs to the local HA (as applicable).
- Support local implementation of applicable business continuity plans (as applicable)
- Responsible for filing, storage and archiving of safety-related documentation in accordance with company’s policies and local requirements.
- Serves as local Subject Matter Expert on relevant PV regulations, processes and procedures.
- 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.
**Education**:
- Health, life science, or medical science degree or equivalent by education/experience (Hiring Manager discretion permitted)
**W ork Experience**:
- Experience in the pharmaceutical industry is required (minimum 3 years)
- Strong leadership, communication, decision making, and problem-solving skills
- 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
**Job-specific competencies & skills**:
- Must be fluent in English (written and spoken) while proficient in local language
- Excellent interpersonal communications, organizational, and presentation skills
- Excellent negotiation and influencing skills
- Ability to work in partnership with others (internally and externally) to accomplish quality goals
- Ability to interface broadly?with colleagues within related functions and cross-functionally and be able to work independently with no supervision except in the most complex of situations.?
- Demonstrates skills to drive change that enhances processes within the company or cross-functionally that improve quality and /or add value to the business.
- Demonstrates strong strategic thinking and project management skills including prioritization
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