Pharmacovigilance Manager

FULLY REMOTE for 24+ months contract

Global Periodic Reports Scientist

Group Purpose Group is accountable for production and submission of periodic aggregate safety reports (PASRs). Accountable for outsourcing of PASRs and periodic reporting processes, schedules, outputs and metrics throughout the product’s life cycle.

Job Summary This Sr. Manager position contributes to the design and development for the operating policies and procedures for the maintenance and management of the client's Safety periodic reporting processes, schedules, outputs and metrics throughout the product’s life cycle. Assesses the effectiveness of the safety periodic reporting processes to determine areas for continuous improvement. Responsible for effective and accurate interpretation of global periodic reporting requirements and partners in the development of processes to reflect global regulatory trends and guidelines representing best in class. Leads negotiations with partner functions across departments (e.g. Development and Clinical, Regulatory, Biostats, Commercial, Business Partners) to achieve the most effective integration of all available skills, tools, and data into the PASR processes to maximize patient safety. Accomplishes PASR preparation through close collaboration with SMEs and external vendors. Responsible for the successful alignment and tracking of periodic report deliverables to ensure global periodic report regulatory requirements are met. Provides centralized mentoring, training, and leadership for Safety and corporate members who work on Periodic Reports. Provides frequent interaction with management on status of the PASR process.

Key Activities Partners in the development of standards for the PASR process,

• Contributes to the design and development of PASR SOPs, QRGS, and applications for PASRs including the development and submission timeline, interface to SMEs within Global Patient Safety and non safety functions that support the PASRs, and QC of documents for completeness.
• Contributes to design and development of software to track PASR processes including the scheduling of PASRs and data specifications for the safety database outputs that support PASR generation.
• Assess the effectiveness of the PASR process for continuous improvement
• Responsible for fostering relationships with the external PASR vendor and all SMEs involved in the PASR process, the development and submission timeline, interface to Global Patient Safety, and QC of documents for completeness.
• Responsible for effective and accurate development and maintenance of Global regulatory requirements and standards for PASRs and serves as level 2 BPO for SOPs, QRGs and templates related to periodic reports.
• Translates PASR country requirements to ensure minimum number of PASRs are prepared to fulfill global needs, negotiating with Local Safety Officers and Regulatory Agencies to enable this.

Responsible for the robustness of the periodic reporting process, successful alignment and tracking of PASR timelines for the scheduling, QC and key performance and key compliance metrics.

Responsible for the periodic reports distribution process covering publishing, distribution, submission, and archiving in close collaboration with Business Partners, Contract Research Organizations, Global Regulatory Operations and Publishing teams,

Ensure end-to-end process adherence by all SMEs involved in PASR process

Responsible for accurate interpretation of regulatory requirements, internal working standards and guidelines to ensure the consistency of PASRs

Represents the activities of Safety periodic reporting process planning in internal committees and with external parties such as regulatory agencies.

• Contributes to strategy for interactions and responses to health authority rapporteurs and oversight bodies such as PRAC.

Ensure frequent interaction and collaboration with Global Patient Safety management e.g. TA Safety Group Heads and non-safety department leadership

Responsible for ensuring client's adheres to and is aligned with Global Health Authority regulations and SOPS regarding all aspects of creating and submitting periodic reports. Monitor changes in regulations to ensure that Client's remains compliant with evolving requirements of the relevant legislation

Responsible to ensure cross-linking and consistency across periodic reports and across product teams to ensure standardization e.g. PBRER/PSUR and RMP

Frequently trains and mentors PASR SMEs with respect to report production

Lead or contribute to cross-functional initiatives aimed to improve pharmacovigilance capabilities to related periodic reports

Apply and inform teams of new or revised regulatory requirements and guidelines relevant to periodic reporting

• Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor

Inspection Readiness

• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
• Manages input from all PASR SMEs

Knowledge and Skills Demonstrate knowledge of global aspects of pharmacovigilance

Strong knowledge of processes and global regulations for pharmacovigilance and periodic / aggregate reporting

Understanding impact of emerging regulatory requirements and their implications

Subject matter expertise and technical excellence

Experience working on cross-functional teams

Good knowledge of IT systems and IT standards

Ability to effectively manage competing priorities and timelines

Excellence in oral and written English

Strong leadership skills, independence, networking and influencing skills and managerial experience to deal with potential conflict of stakeholders with the ability to bring a diverse group to a common decision

• Proven leadership skills in execution of goals and processes

CONTRIBUTION

Ensures client remains in compliance and becomes best in class with regard to periodic / aggregate report processes

Responsible to ensure client is active in regulations, guidelines and industry standards that affect the processes of the periodic report processes.

Executes and maintains document standards

Responsible for successful alignment and tracking of metrics, timelines and performance indicators for PASR objectives

Education & Experience (Basic)

Doctorate degree and 3 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting

OR

Master’s degree and 7 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting

OR

Bachelor’s degree and 9years of pharmaceutical, biotech or regulatory authority experience in a research and development setting

OR

Associate’s degree and 12years of pharmaceutical, biotech or regulatory authority experience in a research and development setting

OR

High school diploma / GED and 14 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting

OR

3 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Education & Experience (Preferred) BS, RPH, RN HCP, or Life Science with 8 - 10 years of directly relevant experience (including 6 years of experience in Drug Safety)

Top 3 Must Have Skill Sets:

- Knowledge of Pharmacovigilance

- Periodic report experience and knowledge of regulations

- Strong understanding of compliance and Pharmacovigilance regulations

- Strong team player will be working with people globally in the organization

Job Type: Contract

Pay: $75.00 - $90.00 per hour

Expected hours: 40 per week

Schedule:

• 8 hour shift
• Monday to Friday

Experience:

• Pharmacovigilance: 8 years (Preferred)
• Periodic Safety Reports: 8 years (Preferred)

Work Location: Remote