MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Post : Senior Specialist, Quality Assurance Pharmacovigilance
Job Description
• Interfaces with relevant stakeholders to provide Pharmacovigilance and QA expertise, compliance advice and guidance, to promote continuous quality improvement and effective quality controls
• In collaboration with the QA, PV Lead, actively contributes to quality management oversight, in the development of and implementation of risk assessments and quality oversight initiatives
• Proactively identify, analyze and leverage quality indicators and data to identify potential risks and trends with a view to
- completing risk-based QA assessments
- performing root cause analyses
- identifying opportunities for quality improvements
- supporting the implementation of associated risk mitigation strategies
- implementing principles of knowledge-based auditing
• Ensures appropriate and timely escalation of quality issues, including critical audit findings, potential misconduct or issues of significant deviation with PV systems/processes/projects
• In alignment with risk assessments, supports the identification of audit targets for scheduling
• Conducts wide range of GPVP (Good Practices Quality Guidelines and Regulations) audits, in accordance with QA risk-based processes, specifically:
- Conducts PV audits of PV systems, Country Operations, business partners and vendors
- May conduct GCP audits, as required and determined appropriate based on knowledge and experience
• Assesses compliance of audit entities against ICH (International Conference of Harmonization), applicable government agency regulations/guidelines, as well as Merck policies, procedures and industry standards. The QAS should have a comprehensive working knowledge of Quality Assurance, regulations and auditing
• Conducts QA audits, generates audit reports, communicates results to the relevant QA management and relevant stakeholders, and interacts with applicable stakeholders to ensure corrective and preventative actions are taken to address QA findings
• Perform independent verification of the completion of applicable corrective and preventative actions taken in response to audit findings, and as appropriate, perform checks to ensure the effectiveness of actions taken to improve pharmacovigilance systems and processes
• Participates in the development/enhancement of QA procedures, guidance documents and audit tools to ensure QA consistency globally.
• Acts as a strong technical resource and is called upon to resolve PV/GCP issues based on knowledge of relevant PV/GCP regulations (global and local) and guidelines as well as applicable standard operating procedures (SOPs)
• Provide inspection management support as appropriate
• Design and actively participate in special assignments on various project teams and work streams
Candidate Profile
Education:
• Bachelor’s degree or equivalent in relevant area
Required:
• A minimum of 5 years of relevant experience in the pharmaceutical industry (i.e., drug development, clinical and/or non- clinical research, regulatory compliance, clinical study monitoring or Pharmacovigilance).
Preferred:
• A substantial work history in pharmacovigilance and/or QA oversight activities, including conduct of audits
Additional Information:
Qualification: B.Sc, B.Pharm
Location: Rahway, NJ, US
Requisition ID: QUA006511
Last Date: 24th April, 2018
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