Overall Purpose of the job:

- Lead the Case Processing and Medical Review team and ensure that all tasks are performed according to business conventions, guidelines and standard operating procedures.

- Manage client interactions related to appropriate processing and evaluation of adverse events

- Ensuring continuous learning and improvement across the teams

- Accountable for quality and consistency of the deliverables

Responsibilities/Authorities:

- Manage the case-flow process across a multi-functional therapeutic team to ensure timely and accurate processing of adverse event cases to meet corporate and regulatory reporting requirements.

- Manage available resources to ensure effective processing of PSSR caseload.

- Take responsibility for implementing the corrective actions resulting from timeliness or quality issues associated with case processing.

- Maintain expertise and knowledge of all assigned products within a therapeutic area; applicable corporate and global regulations, guidelines, Standard Operating Procedures and writing practices; data entry conventions; and search functions in the safety database.

- Work with all other onshore and offshore therapeutic area and shared service roles to promote consistent operations, efficient use of resources and sharing knowledge/ best practices.

- Understand and work to the current divisional/ departmental SOPs and SPIs, ensuring deviations are documented appropriately. Propose new and revise current procedures as appropriate.

- Consistently apply regulatory requirements and Pfizer policies.

- Support the organization and management of inspection readiness activities.

- Support the implementation of corrective actions resulting from timeliness or quality issues associated with safety-related activities for the country.

- Support effective recruitment for the CP and MR; fully utilize corporate tools, to manage the performance reviews of assigned colleagues in the country

- Ensure team members are trained and mentored appropriately

- Work with quality team to help them identify root causes and identify action plans.

- Facilitate effective communication within the team, and with internal and external stakeholders to assure that quality issues are effectively surfaced for resolution.

- Act as a SME for medical guidance for medical reviewers and case processors

- Identify “legitimate” requests to clients to update their conventions and / or improve their consistency

Educational and Experience Requirements :

- Degree/advanced degree in Medicine or Health Care Professional with MD certification preferred

- Minimum of 6-8 years research, clinical or Pharmacovigilance or equivalent experience in the pharmaceutical industry; managerial experience in hospital or pharmacy, and familiarity with clinical assessment is highly desirable

- Experience in managing groups responsible for single case processing and aggregate reports

- Extensive knowledge of Global Pharmacovigilance Regulations

- 6+ years of experience in people management

- Experience and skill with medical writing an advantage

Technical requirements:

- Ability to make independent clinical assessments, based on professional and scientific responsibilities to patients, prescribers, regulators, and providers

- Good understanding of the therapeutic areas and types of products within those areas

- Comprehensive knowledge of current regulations governing the processing and reporting of safety data

- Hands-on understanding of the use of safety databases for adverse event evaluation and reporting

- Leadership skills appropriate for managing a large multidisciplinary team

- Ability to meet personal objectives while meeting departmental standards of performance

- Strong communication and client facing skills

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