Pharmacovigilance Standards Manager

OBJECTIVE:

Functions as the key contact in region for internal audit responses and as the central person for coordinating support and responses for external Pharmacovigilance audits; responsible for communicating audit results to PV senior management team.

Provides leadership for compliance related issues and advises PV management team of potential issues and solutions.

Responsible for development and maintenance of procedural documentation, including SOPs and document management systems within the department.Ensures comprehensive and up to date training of all department staff members including preparation of training materials and provision of training.



ACCOUNTABILITIES:

Obtain and maintain regulatory resources within the department including regulations and guidelines for all relevant territories

Monitor, interpret, and communicate regulatory requirements and ensure that PV is compliant with regulations. Assess relevant regulations and guidelines for their impact on PV compliance strategies and work practices.

Liaise with Case Processing Manager to assist in development of reporting working instructions for studies/compounds

Develop and maintain standard training matrix and training resources for department.

Work with HQ and Training Department to develop appropriate materials and methodologies for training on Pharmacovigilance SOPs. Act as departmental trainer and provide training in all relevant areas, excluding T-Gaea.

Ensure that correct and appropriate records of all departmental training are maintained.

Lead in the preparation, writing, content finalization, and maintenance of local PV SOPs, including consulting with subject matter experts, external functional areas, and the QA Training Department. Ensure local SOPs and all associated documentation are in line with regulatory requirements and global PV SOPs.

Review and provide input into global PV SOPs and other relevant TGRD functional area SOPs

Maintain oversight of compliance to PV SOPs within the department by performing internal reviews of documentation and records.

Act as departmental lead for preparation and training for audits/inspections and participate in audit/inspections as required.

Lead preparation of responses to audit/inspection findings.

Manage corrective and preventative action plans (CAPAs) including assessment of root cause and establishment of timeframes. Perform follow-up audits to confirm corrective and preventative actions are effective.

Assist Senior Director of Pharmacovigilance Systems in oversight of case transmission and regulatory reporting timeline compliance and maintain records for these activities and assist in implementation of CAPA.Establish and maintain document management filing system and ensure correct and consistent utilization. REQUIREMENTS


EDUCATION, EXPERIENCE AND SKILLS:

Degree level qualification (e.g. Bachelors degree) or above in scientific/medical field.

Minimum 5 years experience in pharmacovigilance or experience and experience with participation in pharmacovigilance and/or GCP audits/inspections.

In depth knowledge and comprehension of pharmacovigilance regulations and ability to interpret multiple requirements into concise clear instructions.

Critical thinking and decision-making skills.

Exercise independent judgment.

Understanding Takeda business needs with global business perspective and professional attitude.

Good level of computer literacy with Microsoft applications

Excellent organization skills and ability to prioritizeExcellent written and oral communication skills including ability to present to large internal/external groups and in particular demonstrated abilities in effective training and education of others.

TRAVEL REQUIREMENTS:Estimated 5-10 times per year outside the area including possible international travel.

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