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Career Opportunities in Pharmacovigilance QA as Senior Manager at Novartis

 

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Post : Senior Manager, Pharmacovigilance QA

Job Description
The Senior Manager, Pharmacovigilance QA, provides quality assurance support and expert advice to operational Pharmacovigilance (PV) and Device Vigilance activities within Novartis CMO and Patient Safety in order to ensure compliance with applicable regulatory requirements and Novartis procedures and quality standards. In addition, the Senior Manager PV QA drives a culture of quality by close business partnering, to positively impact the business and implement the Strategy, Mission and Vision of Global Development QA (GDQ) and specifically the Chief Medical Office and Patient Safety function. 

Support maintenance of the Pharmacovigilance System Master File (PSMF) and the Device Surveillance Plan. Lead initiatives to maintain or improve quality performance and compliance of operational Novartis PV activities including case processing, medical safety, risk management, Health Authority reporting, PV IT systems and device vigilance; act as a quality champion. Lead and support initiatives focused on quality, process and compliance improvement. Through close collaboration with business partners, identify opportunities and develop strategies aimed at simplifying processes and improving quality while ensuring compliance with regulatory requirements. Ensure information gained during quality and compliance initiatives, as well as audit and assessment results, is evaluated to identify specific regulatory, compliance and QA training needs for business partners. Lead the development, implementation and conduct of appropriate training. Provide quality support to CMO and Patient Safety with investigations; identify issues and assist with root cause investigations; sign-off investigation reports. Execute deliverables of the Dev Quality Plan, as assigned. Assist with support of Health Authority Inspections; lead inspection readiness activities. Lead and support in the development of corrective and preventative action plans (CAPA) in collaboration with the responsible CMO and Patient Safety team. Monitor status of corrective and preventative actions to ensure the issues are adequately addressed, completed and appropriately documented. Provide assistance in the remediation of PV-related deviations, ensure follow up and monitoring of associated corrective and preventive actions. Ensure quality and regulatory compliance issues are promptly communicated to appropriate management. Lead initiatives geared towards remediation of compliance concerns; determine effectiveness of remediation activities; provide ongoing project support and governance. Deputize for the Head PV QA as needed.

 

Effective coordination, facilitation and follow-up of HA inspections Successful management of the PV-related actions of the GDD Quality Plan Timely escalation through proper channels of issues and findings that impact Novartis’ PV, Patient Safety and risk benefit evaluation capabilities Effective collaboration on quality, compliance, remediation and improvement initiatives Timely review and feedback on policies, guidelines and procedures Timely and effective communication, consultation and support to business partners.

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Candidate Profile :
Degree in Life Sciences or related scientific discipline. Higher degree desirable.

Excellent written and verbal English communication skills; fluency in a second language a plus At least 8 years quality/ PV/ clinical/ regulatory affairs/ pharmaceutical industry/ health authority experience; GCP/PV auditing or inspection experience and Heath Authority interactions desirable;

Experience in maintenance of PV and/or device Quality Management Systems a plus; Ability to travel up to 20%; Ability to independently manage and objectively evaluate complex compliance issues with minimal supervision; Excellent problem solving, decision making and prioritization skills; Quality mindset and excellent quality and compliance leadership and facilitation skills; Extensive knowledge of PV regulations, guidelines and policies; Awareness of GCP and Part 11 requirements; Ability to lead teams and operate successfully in various team capacities and diverse cultural environments; Ability to deputize for the Global Head, PVQA as needed.

Additional Information:
Experience
: 8 years
Qualification: Degree in Life Sciences
Location: Hyderabad
Industry Type: Pharma
Functional Area: Quality
Last date: 20th January, 2017

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