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Especialista Senior de farmacovigilancia

Fecha: 06-nov-2017

Ubicación: Álvaro Obregón, MX

Empresa: MSD

Requisition ID: DRU000722

Major Activities and Responsibilities
(PV Country Lead will amend/delete the lists below according to the actual activities assigned. 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
Merck’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 Merck 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 Merck’s 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, Merck 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.
Qualifications

Qualifications
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.
Functional competencies
PV Intelligence
- knowledge of pharmacovigilance systems & requirements
- understanding of pharmacovigilance principles, concepts, practices & standards
- knowledge of the local country(ies) pharmacovigilance regulations & obligations
- knowledge of Good Clinical Practice concepts
- knowledge of local industry code(s) of practice
- understanding of risk management
Skills
Communication skills
- excellent written & spoken English
- ability to communicate effectively verbally and in writing
- proficient in local language(s)
- proficient in Good Documentation Practices
- basic presentation skills
Computer skills
- good word processing, presentation & spreadsheet application skills
- proficient in the use of a safety database


Job: Drug/Dvcs Sfty Survnce (NonMD)
Other Locations:
Employee Status: Regular
Travel:
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD