Assoc Director - Global Drug Safety, Quality, Training & Complianc

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Think What's Possible.Position Purpose :

Responsible for the management of the Global Drug Safety Quality, Compliance & Training Group. Coordinates auditing of safety data handling in DSP (NJ & Nyon) as well as affiliates. Also supervises QA/QC of safety data processing globally. Knowledge source for world-wide safety regulations and industry trends. Supervises trainer in the group as well as coordinating training handled by the trainer in Nyon. Training coordinator for adverse events reporting within the whole Novartis Consumer Health OTC BU.

General Task

Working with staff and Medical Safety Associates, ensures that up to date and version controlled training materials are prepared, available and catalogued. Performs customer tailored SOP, ARGUS and MedDRA training in the US, interacting/assisting DSP affiliates and also other NCH OTC line units under the direction of the Global Head Drug Safety & Pharmacovigilance. This position will reside in the US-Parsippany NJ.

Key Responsibilities:

Supervises, plans and conducts internal quality and compliance inspections of drug safety functions in NJ/Nyon/affiliates/line units as needed. This includes but is not limited to case processing, MedDRA and drug coding consistency, case and non-case identification, case deletion, SOPs and working documents, labeling documents, archiving, literature search, regulatory document preparation etc.
Supervises and assists in internal DSP QA and QC functions. Works closely with the Quality Group in Parsippany, Nyon, Basel and E. Hanover.
Supervises global training. Supervises and coordinates training group in NJ and dotted line responsibility for training group in Nyon. Ensures that a training matrix, core curriculum for new hires and current employees as well as specific training plans are prepared and updated. Ensures that training is performed for all NCH BU personnel requiring training including direct training and "train the trainer" training. Certifies trainers as appropriate. Liaison to training groups in Basel, E. Hanover and other BU as appropriate.
Assists in training, auditing and QA/QC of call centers globally.
Creation and maintenance of corrective action/preventative action plans for compliance concerns (i.e. ADE reporting, inspections, training concerns) following audits by Pharma, FDA, EMEA or other internal or external groups. Issues update reports to auditing group as appropriate.
Provides assistance (facilitation, scribing, escorting etc.) during health authority audits and in preparation of any needed responses.
Supervises and assists in preparation of Quality Reports and monthly DSP reports.
Collaborates with other departments to identify potential compliance concerns effecting NCH-OTC-DSP
Monitors and if necessary assigns ISEC compliance activities within NCH-OTC-DSP to appropriate team members
Prepares and tracks safety intelligence issues in conjunction with the DSP Medical Safety and Epidemiology Group.
Supervises the identification of process improvement needs and root cause analysis of quality and compliance issues.
Attends all necessary internal and external meetings/activities related to job functions
Functions as DSP Privacy Officer.
Works closely with QP, Europe and Head of DSP Europe/ROW
Travel as needed
All work will meet quality requirements consistent with:
Novartis standards
Health authority standards
Industry standards

Qualifications
Position Requirements & Education
Qualifications and experience:
Degree in pharmacy (RPh, PharmD), or nursing (RN, LPN) or life sciences (e.g. MD, DDS, DPod, PA).
4-5 years experience in Drug Safety
Knowledge of quality, compliance and training requirements for drug safety.
Knowledge of GCP regulations, and reporting requirements for US, EU (and elsewhere if possible)
Experience in inspections and auditing and AE case databasing. is highly desirable
Previous managerial experience
PC knowledge in MS Office, EXCEL and PowerPoint applications
Excellent written and spoken English.

Skills and knowledge:

Leadership skills

Excellent oral and written presentation skills
Interpersonal communications and negotiation/problem solving,
Capacity workload planning and prioritizing,
Report writing
Team work
Multi-tasking

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
Flexibility
Willingness to travel


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

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