MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company : one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
The 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 MSD policies and procedures. He/she is able to function independently in the processing of adverse events.
This includes the procedural responsibilities in 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. As requested by the PV Country Lead, the PV Specialist may undertake other additional activities including projects.
The position reports to the PV Country Lead.
Major Activities and Responsibilities
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 MSD’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 MSD’s policies and local requirements.
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.
Assist in preparation for audits/inspections for their country/territories and may participate in the audit and/or inspection.
Identify and communicate potential safety issues to PV Country Lead.
Assist in the delivery of 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.
Complete and document required PV training within the required timelines.
Perform other activities as requested by the PV Country Lead.
Liaise with Data Management Centres and Global Safety Global Case Management at HQ
The incumbent must have a health, life science, or medical science degree or equivalent by education / experience. He/she should have at a minimum 1 year of pharmaceutical industry experience. He/she must have an awareness of Pharmacovigilance regulations within his/her assigned country(ies). The PV Specialist is expected to have strong communication and time management skills, and have the ability to work independently with minimal supervision.
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