Medical Safety Associate, Global Drug Safety Quality and Compliance

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Think What's Possible.Position Purpose:

Assist in fulfilling compliance activities within Novartis Consumer Health (NCH), Over-the-Counter (OTC) Drug Safety and Pharmacovigilance (DSP) US to meet Novartis internal requirements and legal obligations, with special emphasis on compliance, internal inspections, generation of quality and compliance reports and assistance in audits by governmental health authorities.


Position Description:

Assist and conduct audits (routine and directed) globally for Novartis Consumer Health Drug Safety. Perform analysis of audit results, effectively communicate and document GxP issues, recommendations and corrective actions. Provides regulatory/GCP guidance, interpretation of regulations and participates in GCP training programs. Proactively researches safety intelligence including local and International GDP trends and initiatives to ensure Novartis Compliance. Conduct Investigations and root cause analysis of late safety reporting submissions worldwide. Assist to develop an overall approach for end user training, assess training needs, curriculum plans and develop global training materials as needed.

The major duties include:

Assists in coordination, planning and conduct of inspections and audits; issues audit reports and reviews and approves corrective action plans following inspections and audits.
Provides interpretation of GCP regulations, guidelines, policies and procedures and provides sound guidance to Novartis Personnel and contracted service providers, both verbal and written.
Coordinates and takes part as necessary, in the preparation, timely issue, review, updating and archiving of standard operating Procedures (SOPS).
Provides regulatory /compliance guidance and interpretation and represents Compliance & Safety Intelligence in Internal and external meetings.
Compiles audit metrics and monthly performance reports.
Provides assistance during health authority audits and in preparation of any needed responses
Develops and implements GCP training programs as needed; also provides training within Pharmacovigilance as needed.
Participates in process improvement initiatives
Assists in safety intelligence data gathering and analysis
Participates in conducting root cause investigations and monitoring corrective actions for late health authority case reports. Conducts formal investigations of issues as they arise.
Tracking of corrective action plans (CAP) and audit closure within established timelines.
Interact with all line functions within Novartis OTC and provide adverse event training to Sales Force as needed.
Alerts the clinical teams to study related non-compliance issues.
All work will meet quality requirements consistent with:
Novartis standards
Health authority standards
Industry standards

Qualifications
Position Requirements & Education:
B.A. or B.S. required
Degree in pharmacy (RPh, PharmD), or nursing (RN, LPN) or life sciences (e.g. MD, DDS, DPod, PA).


Experience & Knowledge:
1-2 years experience in Drug Safety
Working knowledge of current national and international regulations pertaining to drug safety desirable.
Experience in inspections and auditing is highly desirable.
Knowledge of GCP regulations desirable
Knowledge in computer validation and Part 11 requirements desirable.
PC knowledge in MS Office, EXCEL and PowerPoint applications
High standard of written and spoken English.
Highly developed verbal and written communication skills in the English language

Behavior
High ethical and moral attributes
Open and honest
Ability to quickly adjust to changing priorities
Ability to work with minimum supervision
Ability to work under pressure and meet deadlines
Ability to handle multiple projects at once
Ability to meet and maintain very tight deadlines while maintaining organization and excellent punctual work ethics.
Highly responsible, with the ability and willingness to initiate and demonstrate autonomy of thought and action.


Scope of position:
Supervision Received: Reporting to Manager of Quality and Compliance


Novartis is committed to embracing and leveraging diverse backgrounds.
Novartis is an equal opportunity employer M/F/D/V.

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