Medical Quality Oversight Officer

PFIZER LUXEMBOURG SARL, organizačná zložka

Place of work
Tower 115, Pribinova 25, Bratislava
Contract type
full-time, part-time
Start date
15.09.2018
Basic wage component (gross) and other rewards
1500 EUR - podľa seniority kandidáta

Information about the position

Job description, responsibilities and duties

MAIN REPONSIBILITIES / DUTIES:

The Medical Quality Oversight Officer (MQOO) role drives quality management, compliance, inspection readiness, training, process improvements, and oversight needed to ensure high quality performance of Pfizer Country Medical Operations. Leads or supports regional quality related projects across BUs.

Quality Management

• Drive the local Country Quality Management System
• Contribute to regional and global quality strategic initiatives in partnership with Global MQO leadership
• Lead the development of country quality strategic initiatives based on risk and business needs, in close collaboration with Local Medical Management, MQO Leadership, BU Markets and other key stakeholders (e.g., Platform Line management [Safety, Regulatory]
• Development and maintenance of Country Quality Plan
• Participation in Country Medical Council
• Demonstrate value proposition of MQO to internal stakeholders and external customers.
• Quality consulting activities (e.g., answer to queries on medical quality requirements, CEPs, Promotional Compliance)
• Ensure appropriate connections to internal stakeholders acres lines
• Participate in appropriate regional governance structures (e.g. Promotional Materials Steering Group)

Audits & Inspections

• Lead continuous inspection readiness efforts in collaboration with applicable headquarters inspections management teams, Business Units, and Platform Line representatives
• Communicate relevant Inspection / audit trends to respective country stakeholders, drive that applicable actions are taken to address country gaps
• Develop and maintain the in-country Regulatory Inspection Action Plan. Lead, coordinate or support local regulatory authority inspections as per Pfizer standards, depending on inspection scope
• Coordinate internal audits within the scope of in-country Medical Operations, including management of audit Corrective & Preventive Actions (CAPAs). Support external inspections as appropriate

SOPs & Other Procedures

• Drive the local impact assessment of new and revised local regulatory requirements and ensure these are appropriately documented in in-country controlled documents within MQO remit
• Develop (and/or support the development), implement and maintain in-country controlled documents within the scope of QMS04 in collaboration with relevant Subject Matter Experts, meeting the business needs for the area under the scope of MQOO
• Ensure local controlled documents within MQO remit are in compliance with applicable Pfizer policies and procedures and regulatory requirements.

Training

• Act as a local Subject Matter Expert on local training management and Pfizer’s Global Learning Management System
• Ensure country colleagues have sound knowledge of regulatory requirements: in collaboration with local Management, identify additional training needs (in addition to P2L mandatory requirements); facilitate / support / conduct of additional training for identified areas.
• Support training compliance reporting for regional colleagues

Ide o kontraktovanú pozíciu prostredníctvom personálnej agentúry.

Information about the selection process

Expected date of completion of the selection process

15 September 2018 (there are still 30 more days)

Requirements for the employee

Candidates with education suit the position

University education (Bachelor's degree)
University education (Master's degree)

Educational Specialization

medicine or equivalent suitable scientific background

Language skills

Slovak - Proficiency (C2) and English - Upper intermediate (B2)

Other knowledge

Microsoft Excel - advanced
Microsoft Outlook - advanced
Microsoft Word - advanced
Microsoft PowerPoint - advanced

Number of years of experience

3

Personality requirements and skills

Education & Experience

• Scientific or technical degree is preferred: BS or MS and over 3 years’ experience in compliance/SOP management, auditing, QA/QC or related field
• Previous experience from the Safety, Clinical or Regulatory – advantage
• Understanding of the local promotional compliance environment
• Appreciation of the regulatory compliance issues relating to the local medical function
• Previous experience in a role involved in the drug development process is valued
• Supervisory experience in a matrixed organization is valued
• Knowledge of training design and tools and experience in applying training methodology is considered a plus

Desired technical and behavioral skills:

• Fluency in English
• Expertise in managing multiple complex projects
• Consultancy skills
• Ability to work independently
• Able to lead withou reporting line authority at senior level
• Project Management expertise
• Excellent verbal, written, and presentation skills
• Collaboration, interpersonal and facilitation skills
• Continuous Improvement and/ or organizational effectiveness expertise
• Displays sensitivity to manage relationships and ability to build collaborative working relationships with colleagues and associates both within and external to the organization;
• Collaborates efficiently across functional and country boundaries, respecting communication, functional priorities and cultural differences in interpersonal relationships

Advertiser

Brief description of the company

Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for people. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

Number of employees

50-99 employees

Company address

PFIZER LUXEMBOURG SARL, organizacna zlozka
Tower 115, Pribinova 25
811 09 Bratislava

Contact

Contact person: Mgr. Lucia Tóthová
E-mail: send CV
ID: 2098983   Dátum zverejnenia: 8.8.2018   Základná zložka mzdy (brutto) a ďalšie odmeny:   1500 EUR - podľa seniority kandidáta