Pharmacovigilance Responsible Person Job

Date: May 16, 2019

Location: Skopje, 77, MACEDONIA (THE FORMER YUGOSLAV REPUBLIC OF)

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Requisition ID: REG004339

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


 


MSD is home to a diverse team of scientists and researchers who are working to push the boundaries of global healthcare through research and innovation. Relentlessly curious and driven, the Pharmacovigilance team produces effective, reliable medicine through clinical trials and surveillance that uncovers new knowledge, product discovery, and leading-edge medical breakthroughs.


 


Summary of Position


The Pharmacovigilance (PV) Responsible Person is responsible for the assigned PV activities of the local country operations for the specified country(ies) including compliance with PV processes and regulations and MSD policies and procedures. The incumbentmay represent MSD for safety issues at the country level, interfacing with the country heads of Global Clinical Trial Operations (GCTO), Global Regulatory Affairs (GRA), Global Medical Affairs (GMA) and other business units to ensure alignment on issues impacting PV.



Depending on the assigned activities, this may include the procedural responsibilities in the areas of:




  • Adverse experience case management including HA submissions; aggregate safety report health authority submissions; health authority submission compliance for individual case safety reports and aggregate safety reports; local contractual PV agreements including support to Global Safety Regional Lead for due diligence activities; country level audits and inspections; local initiatives, LCEs, PASS and PMAS; country PV standard operating procedures; and communication of safety issues to Global Safety (GS) PV Country Lead or GS Regional Lead.



  • The position has a dotted line report to a PV Country Lead or GS Regional Lead and a direct reporting line to the next level manager in their functional unit.

 



Major Activities and Responsibilities


 


Performs the following independently:




  • Responsible for adverse experience case management in his/her country(ies) of responsibility, 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.


  • Liaise with Data Management Centers, as necessary.



  • Responsible for aggregate safety report submission management in the country(ies), including report scheduling, submissions and submission compliance entries in accordance with Global Safety procedures and health authority requirements.



  • Responsible for the reconciliation of adverse events reports received from other MSD operating units (e.g., Designated Point ofContact, 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.



  • Serve as the Local Qualified Person for PV (QPPV) / local responsible PV person for the country(ies) and assign a back-up, if required by local regulations.



  • Responsible for ensuring of after-hours coverage and for maintaining adequate back-up coverage to ensure business continuity during periods of closure, absence, etc.



  • Responsible for being compliant with local PV regulations, MSD policies and procedures and Global Safety procedures at the country level.


  • Responsible, as directed and if required, for the qualification and ongoing audits of vendors (e.g. external archiving facility) in the country(ies).



  • Accountable for the delivery, documentation and tracking to completion of training, customer facing non-PV staff (e.g., Sales Reps, Medical Information, etc.) and distributors / vendors / business partners in the country(ies) within scope.



  • Responsible for completing, documenting and filling the required PV training.



  • Identifies and communicates potential safety issues to PV Country Lead &/or GS Regional Lead.

 

Qualifications

Works with the PV Country Lead or GS Regional Lead, as applicable, for the following:




  • Preparation of requests for updates/changes to country-level listings for the global safety database and the escalation of global safety database-related problems arising in country(ies).



  • Pharmacovigilance reporting language in local country agreements, working with the Regional Support Officer (RSO) and liaising, as necessary, with the business partner. With the RSO, update/maintain the master contract list with respect to local contracts.



  • Develop and maintain the necessary PV process(es) to ensure early awareness by PV and review of business agreements for PV language requirements.



  • Writing and maintaining the local country PV SOPs, including alignment with MSD policies and procedures and with Global Safety procedures.



  • Monitoring of individual case safety report compliance and aggregate safety report compliance and responsible for the implementation of corrective actions locally, as necessary, for late reporting.



  • Monitoring of new/revised HA regulatory information related to PV and for the timely implementation of the new/updated PV regulations communicating changes to the GS Regional Lead.



  • Acting on behalf of the EU-QPPV(s); the management of the local country PV system on behalf of the EU-QPPV(s) as described in the current version of the EU-QPPV SOP(s) is a formally delegated task of the PV Country Lead.



  • Audit and inpsection activities in the country(ies), including internal audits, verification audits, local BP audits and health authority inspections. Dependent on the audit/inspection type, responsibilities include work on readiness activities; Participation in the audit / inspection; development and completion of CAPA plans; and assembling of evidence for CAPA closure and for verification audits.



  • Reviewing of local initiatives (e.g., websites, registries, marketing initiatives), local clinical evaluations, market research, postmarketing active surveillance (PMAS), patient support programs (PSPs) and post authorization safety studies (PASS) protocols for compliance with PV requirements, as applicable. With the PV Country Lead or GS Regional Lead, as appropriate, in the country(ies), be the recognised owner of the PV requirements and lead discussions / consultations on the PV aspects of the local initiatives, local trials, PMAS, PSP, and PASS. Ensure that processes for the required reviews are established and maintained.



  • Identifying and communicating potential safety issues to the GS Regional Lead and /or Global Safety Headquarters



  • Serve as the point of contact for the local Health Authority and/or liaise with the Global Regulatory Affairs (GRA) / Global Medical



  • Affairs (GMA) colleagues for questions from the Health Authorities regarding safety and ICSRs.



  • Liaise with the country heads of Global Clinical Trial Operations (GCTO), Global Regulatory Affairs (GRA), Global Medical Affairs (GMA) and other business units to keep them apprised of safety activities and provide input on strategic decisions (i.e., new clinical trials, product launches, etc.).



  • Liaise with the Country Leaders and colleagues in Global Clinical Trial Operations (GCTO), Global Regulatory Affairs (GRA), Global Medical Affairs (GMA) and other business units to ensure processes are in place for activities that are performed by those functions which impact PV. Pro-actively engage with these groups and their leadership for local programs that have a PV component, thereby ensuring awareness within Global Safety of upcoming programs and progress / closure with existing programs. Liaise with the EUQPPV (periodic and ad-hoc, as applicable) in consultation with GS Regional Leader, to enable the EU-QPPV to maintain PV system oversight.



  • Participate on corporate sponsored committees and councils (i.e. Medical Governance Council). As a member of the Medical Governance Council, represent Global Safety on matters / activities that impact or involve PV, thereby ensuring that the requirements in Global Safety procedures and the relevant Corporate Policies are met.

 


 

Background Requirements

 

 

The incumbent must have a health, life science, or medical science degree or equivalent by education. He/she should also have at a minimum 3 years of relevant industry / pharmacovigilance experience and he/she must have knowledge of pharmacovigilance principals, concepts, systems & requirements as well as pharmacovigilance regulations within the country(ies) assigned. A basic understanding of Good Clinical Practice (GCP) concepts is expected. Fluency in English is required.


Strong communication, project management, problem-solving skills are expected, along with a demonstrated ability to build and manage close relationships with key individuals in his/her country(ies).


 


 


Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.


 


 


 


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Job: Regulatory Affairs/Compliance
Other Locations:
Employee Status: Regular
Travel: No
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


Job Segment: Medical, Law, Pharmacovigilance, CAPA, Compliance, Healthcare, Legal, Management

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