Mohammad Abutalaha

Job Purpose

Maintain compliance to adverse event training for employees, vendors and customers, including vigilance contracts. Ensure global change in regulations are tracked and implemented for compliance within Alcon Quality System. Support and manage required periodic reports to Health authorities. Periodic reviews and reconciliations of Pharmacovigilance Master Safety File (Annex B, 9.6)

Major Accountabilities

· Managing the team in providing support to customer.

· Handles queries from the team members and provide clarifications.

· Guide/Mentor team members as and when required.

· Conduct knowledge transfer sessions.

· Participate/lead meetings as required.

· Perform Adverse Event training for employees, vendor and customers and maintain training records

· Review, revise and provide feedback on the vigilance language within the contracts to ensure the vendors and customers are compliant to vigilance requirements

· Track, coordinate, and implement any change in global regulations for medical devices to ensure compliance to applicable Health Authority (HA) requirements

· Partner with functional and global teams as needed to perform the job responsibilities and escalate any issues or challenges in a timely manner

· Serve as a subject matter expert during internal and external audits

· Coordinate and communicate as needed with HA to understand and implement change in regulations within Alcon quality system

· Own the processes, drive continuous improvements to gain efficiency and effectiveness as required

· Responsible to investigate root-cause, implement immediate mitigation and drive corrective actions for any audit findings or deviations as applicable

· Run reports and retrieve required information from IBM Cognos analytics platform on a daily basis.

· Perform investigation for any non-conformance, determine root-cause and implement required actions

· Participate in internal and external audits as subject matter expert

· Track required metrics for process oversight and escalate any issues

· Exercise judgment within defined procedures and practices to determine appropriate action

· Recommend changes to improve practices and procedures.

Job Purpose

Maintain compliance to adverse event training for employees, vendors and customers, including vigilance contracts. Ensure global change in regulations are tracked and implemented for compliance within Alcon Quality System. Support and manage required periodic reports to Health authorities.

Case Processing:

• Process case files according to Standard Operating Procedures (SOP).
• Work with affiliate offices to ensure required dataset has been received/requested.
• Re-assess the data, ensure accurate product selection and assign required event code(s) in the system.
• Complete initial and follow-up reporting assessments as information is received (initial report, follow-up questionnaires, phone calls, investigation findings).
• Respond to Manufacturing Quality Assurance (QA) requests and Health Authority inquiries
• Launch required quality investigation records.
• Schedule expedited and periodic regulatory reports based on local and international reporting regulations.
• Perform and receive quality feedback on case management and coding.
• Mentor new hires in the team.
• Adherence to all corporate compliance guidelines & corporate programs .
• Maintains a working knowledge of the following:
• Alcon Products for assigned therapeutic areas and corresponding documentation (Product Information, Directions for Use, Manuals, Promotional materials)
• Eye anatomy
• Common diseases
• Ophthalmic evaluation procedures
• Eye terminology and abbreviations
• Safety database(s) and reporting tools
• Process and review Surgical – Intra Ocular Lens (IOL) complaint records in accordance with Alcon Standard Operating Procedures (SOPs) Provides suggestions to management on opportunities for continuous improvement, and actively engages as a team member in such projects. Provide support in reconciliation activities and audit as required. Evaluate and escalate potential safety issues to management.

Experience and Job Role:

- Responsible for processing Adverse Event cases to ARIS-g database provided by the client.

- Responsible for case intake, duplicate check and registration.

- Maintain log of source documents and other communications.

- Review and evaluate AE case information to determine required action based on and following internal policies and procedures.

- Process all incoming cases in order to meet timelines.

-Assist in signal generation and safety analysis activities.

-Review of literature articles to identify case safety reports.

-Responsible for operational pharmacovigilance activities for assigned developmental and/or marketed products.

-Responsible for entering

(a): Source document details

(b): Cross reference

(c): Case/Patient information

(d): Past medical history

(e): Reporter information

(f): Event information

(g): Product information of suspects and concomitant drugs, their dosing schedule, indication

- Responsible for coding of all medical events, drugs /procedures/implements according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD)

- Responsible for writing medically relevant Safety narrative of cases and checking the completeness and accuracy of the medical data entered in the various fields.

-Responsible for various reconciliations for the cases every month.

Other Responsibilities:

- Following up with sites regarding outstanding queries.

- Follow up on reconciliation of discrepancies.

- Follow departmental AE workflow procedures.

- Closure and deletion of cases.

- Mentor and guide the activities of the Drug Safety Associate.

- High level of proficiency of all workflow tasks.

- Perform any other drug safety related activities as assigned.

-Involved in validation activity for upgrading Aris-g database.