Senior Pharmacovigilance Specialist

Senior Pharmacovigilance Specialist

Merck Sharp & Dohme Corp.


Quintana Roo



Senior Pharmacovigilance Specialist

Detalles de la oferta

Senior Pharmacovigilance Specialist Job

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Senior Pharmacovigilance Specialist

Summary of Position

The Senior (Sr) Pharmacovigilance (PV) Specialist is responsible for the day-to-day case management activities within the country(ies) covered by the country operation including compliance with PV processes and regulations and policies, procedures and is able to function independently in the processing of adverse events.
In the absence of the PV Country Lead, he/she is responsible for overseeing and managing the day-to-day activities of the local country operations Pharmacovigilance Department.
Procedural responsibilities include the areas of: Adverse experience case management including HA submissions; aggregate safety report health authority submissions and health
authority submission compliance for individual case safety reports and aggregate safety reports.
The Sr PV Specialist acts as backup for the PV Country Lead and, as requested by the PV Country Lead, the Sr PV Specialist may undertake other additional activities including projects.

Major Activities and Responsibilities

It is not an expectation or requirement that the Sr PV Specialist undertakes all the activities / responsibilities listed.
Responsible for day-to-day adverse experience case management within the country(ies) covered by the country operation including case intake and follow-up activities in accordance with Global Safety procedures, the review of local literature as per the organization's procedure and country regulations, and health authority submissions of cases in accordance with Global Safety procedures and health authority requirements.
Responsible for aggregate safety report submissions in the country(ies) in accordance with Global Safety procedures and health authority requirements.
Responsible for the reconciliation of adverse events reports received from other operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners, as applicable.
Responsible for the filing, storage and archiving of safety-related data in accordance with policies and local requirements.
Serve as the local Deputy Qualified Person for PV (QPPV) / deputy local responsible PV person for the country(ies) when delegated by PV Country Lead.
Serve as back-up in the absence of the PV Country Lead to ensure business continuity.
Responsible for being compliant with local PV regulations, policies and procedures and Global Safety procedures at the country level.
Participate in individual case safety report compliance activities and takes the necessary corrective actions locally for the late reporting within the country(ies) covered by the country operation.
Prepare for audits/inspections for their country/territories and participate in the audit and/or inspection.
Identify and communicate potential safety issues to PV Country Lead.
Deliver training to PV staff and customer facing non-PV staff (e.g., Sales Reps, Medical Information, etc.) and distributors / vendors /business partners in the country(ies) within scope.
Train and mentor PV staff, if applicable
Complete and document required PV training within the required timelines.

Background Requirements

The incumbent must have a health, life science, or medical science degree or equivalent by education / experience and should have a minimum 2 years of pharmacovigilance experience.
He/she must have a sound knowledge of Pharmacovigilance regulations within his/her assigned country(ies). The Sr PV Specialist is expected to have strong communication and time
management skills, and have the ability to work independently with minimal supervision.

Fuente: Neuvoo_Ppc


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