Pharmacovigilance SpecialistTASC Outsourcing

The incumbent is responsible for supporting Pharmacovigilance related activities in the GCC region and as required by Marketing Authorization Holders (MAH) and/or study sponsor, as applicable. Also, will ensure the maintenance of an appropriate PV, vigilance system and Risk Management to assure appropriate oversight for products within its responsibilities.

MAIN RESPONSIBILITIES:

Local Safety Officer Responsibility & Benefit Risk Management:

· Establish Product knowledge with focus on safety profiles, Therapeutic Area and Disease Pathway knowledge supporting the needs of the local Medical and Marketing organization in collaboration with the International Medical Safety leader or Medical Safety Officer and the Country Safety team lead (CSTL), as applicable.

· Act as safety expert in cross-functional team meetings and perform training on safety relevant aspects, as appropriate.

· Prepare Local RMPs/ Addendums etc. if required.

· Involve in implementation of Risk Management Plans and Urgent Safety Restrictions, if required.

· Ensure proper oversight on Educational Materials (ARMA/CARMA/ DHPCs) implementation/retirement across the region, and maintain proper tracking in collaboration with relevant stakeholders

· Support in the implementation of Company Core Data Sheet (CCDS) into local label (SmPC, patient Leaflet etc.), when required.

· Undertake appropriate actions such as site visits for special interest cases for special interest cases.

Clinical activities compliance

· Ensure proper oversight on Clinical Trials across the region and provide input into safety sections of local protocols (including Clinical Trials, Non-Interventional Studies, Research Related Activities, Patient Support Programs etc.) to ensure appropriate safety reporting as required by regulations.

· Collaborate with Medical Affairs for the review and approval of safety aspects of local study protocols or Patient Support Programs to ensure appropriate safety reporting to Global Medical Safety or appropriate case management center and Regulatory Authority (RA), as required.

· Perform protocol review related to data generation activities - clinical and post-authorization studies and Local Safety Monitoring Plan (SMP).

Local Safety Communications

· Take appropriate measures to ensure that new safety information is available to Health Authorities and Health Care Professionals (HCPs) in a timely manner, i.e., Safety Significant Issues (SSI), Emerging Significant Issues (ESI), Dear Health Care Professionals (DHPC), etc. as required.

Pharmacovigilance and Vigilance Service Provision

· Collaborate with CSTL and other national QPPVs/backup to ensure that day-to-day Pharmacovigilance activities and safety activities for non-medicinal products (i.e., cosmetics, medical devices, commodities, nutritional) are performed satisfactorily- including translation, follow up request, local literature review, submission to RA, as applicable- and that full regulatory compliance is maintained at Local Operating Company level including adequate record management.

Agreements / Contracts containing PV Language

· Perform contract review and maintain oversight on the commercial and vendor agreements to ensure safety reporting obligations are defined and integrated, seek support from central functions, as necessary.

· Coordinate the provision of third-party safety agreements with PV implications at the local level and ensure the PV agreement is implemented locally, including Local Safety Unity (LSU) training and adherence to PVAs, as appropriate.

Audit/Inspection preparation & Support

· Ensure PV Audit/ inspection readiness on the LOC level.

· Act as the local PV contact person for local PV audit and inspection and support document requests in collaboration with case management team and other stakeholders.

· Support CSTL in the assessment and investigation triggered from audit observations or other identified compliance issues, as required.

· Act as CAPA Content owner and subject matter expert, own actions as required - depending on topic and consult with CSTL as appropriate.

Safety regulations

· Report regulatory requirements for MAH and/or study sponsor as applicable as per process.

· Support the review of new/revised safety regulations (for drugs and non-medicinal products in scope of responsibilities), evaluation of the impact on local processes and notification of appropriate global and regional groups via central PV policy tracker about changes in local regulatory safety including cosmetics and medical device safety reporting requirements

· Implementation of new legislations with local impact for IPV owned activities, depending on topics.

Training

· Ensure proper documented training on safety reporting responsibilities of LOC personnel and maintenance of awareness of safety reporting in general.

· Perform training for Local Operating Company employees covering (pharmacological) safety aspects of products as applicable.

· Perform training for Local Operating Company employees covering follow-up process for concepts of special interest, as applicable.

Business Continuity

· Support CSTL to ensure creation and implementation of local business continuity plans in collaboration with case management team.

· Ensure an effective PV system is in place for 24-hour coverage.

· Ensure that day-to-day PV functions are performed satisfactorily, and that optimal regulatory compliance is maintained at the LOC level in collaboration with case management team and CSTL.

JOB REQUIREMENTS

Qualification & Experience

· Minimum of 2-3 years’ experience in a healthcare compliance role or similar

· Bachelor’s degree in life science/ pharmacy preferred

· Proficiency in medical terminology (local languages)

Knowledge & Skills

· Good verbal and written communication skills,

· Good in data analysis and reporting

· Proficiency in global and local SOPs

· Team player

· Ability to negotiate and communicate with internal and external customers.

· Ability to establish and maintain open relationships within the organization and with authorities.

· Ability to manage multiple critical issues and work under pressure