Senior Pharmacovigilance Specialist

Job descriptionSenior Pharmacovigilance SpecialistDRU000227DescriptionThe Senior Pharmacovigilance PV Specialist reports to the Pharmacovigilance Country Lead and is responsible for case management activities for Postmarketing and Investigational products in the countryterritory. HeShe is responsible for overseeing and managing the daytoday activities of the local country operations Pharmacovigilance Department in the absence of the Pharmacovigilance Country Lead. The Senior Pharmacovigilance Specialist complies with PV processes and regulations and Merck policies and procedures for hisher country operationterritory. This applies to all relevant safety information. The Senior Pharmacovigilance Specialist is qualified to function independently in the processing of Adverse Events. HeShe acts as backup for the Pharmacovigilance Country Lead and is responsible for specific delegated tasks.Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. MSD’s benefits are designed to support the wide range of goals needs and lifestyles of our employees and many of the people that matter the most in their lives.MSD is an equal opportunity employer proudly embracing diversity in all of its manifestations.1. Translate and process spontaneous and solicited clinical trial adverse events reports from their countryterritories and enter them into the Global Safety database or forward to a designated data entry center or contractual partners2. Conduct followup as required3. Conduct reconciliation of adverse events reports received from other Merck operating units e.g. Designated Point of Contact Medical Information etc. and contractual partners as applicable4. as applicable spontaneous and solicited clinical trial individual case safety reports ICSRs from their countryterritories to the local Health Authorities5. File store and archive safetyrelated data6. Serves as backup coverage in the absence of the Pharmacovigilance Country Lead to ensure business continuity7. Serves as the local Deputy Qualified Person for PV for their country in the absence of the local Qualified Person for PV when delegated8. Comply with PV regulations and Global Safety policiesprocedures and when needed take corrective action9. Participate in individual case safety report compliance activities and takes the necessary corrective actions locally for late reporting within their countryterritory10. Prepare for auditsinspections for their countryterritories and participates in the audit andor inspection11. Identify and communicate potential safety issues12. Deliver training to PV staff and customer facing nonPV staff e.g. Sales Reps Medical Information etc. and distributors13. Train and mentor PV staff14. Complete and document required PV training within required timelinesQualificationsThe incumbent must have a health life science or medical science degree or equivalent by experience and be fluent in English while proficient in local language.Heshe should have at a minimum 2 years of industry experience in pharmacovigilance.have extensive knowledge of Pharmacovigilance regulations in their countryterritory.strong communication and time management skills and have the ability to work more...

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