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.
The Pharmacovigilance (PV) Country Lead is responsible for the day-to-day PV activities within his/her country(ies) including compliance with PV processes and regulations, MSD policies and procedures, representing the Company for safety issues at the country level and 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.
This includes 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) Regional Lead. If managing a pharmacovigilance team, responsibilities include staff resourcing, training and development and training tracking. As requested by the GS Regional Lead, the PV Country Lead may undertake other additional activities including projects. Some travel may be required. The position reports to the GS Regional Lead
Major Activities and Responsibilities:
- 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 procedure and country regulations, and health authority submissions of cases in accordance with Global Safety procedures and health authority requirements.
- Associated responsibilities include the 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).
- 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 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 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 the 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
- Responsible for writing and maintaining the local country PV SOPs, including alignment with Merck policies and procedures and with Global Safety procedures. esponsible for being compliant with local PV regulations, Merck policies and procedures and Global Safety procedures at the country level.
- Accountable for 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.
- Responsible for the 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.
- Responsible for 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.
- Responsible for the audit and inspection 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.
- Responsible, as directed and if required, for the qualification and ongoing audits of vendors (e.g. external archiving facility) in the country(ies). Responsible for reviewing 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. As the Global Safety representative 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.
- Responsible for identifying and communicating potential safety issues to the GS Regional Lead and /or Global Safety Headquarters
- Accountable for the delivery, documentation and tracking to completion of training for PV staff, customer facing non-PV staff (e.g., Sales Reps, Medical Information, etc.) and distributors / vendors / business partners in the country(ies) within scope.
- As applicable, responsible for the recruitment, development and performance management of Pharmacovigilance team/personnel within the country(ies) As necessary, discuss resource issues with GS Regional Lead..
- Responsible for the availability of current organisation charts, s, CVs and training records for all PV staff within the local country(ies).
- Responsible for communicating changes to the local PV staff (permanent and temporary) to GS Regional Lead.
- Responsible for maintenance of budget for country Global Safety activities.
- 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.
- Act as liaison between Legal and Global Safety for local country legal complaints / litigation as needed Liaise with Data Management Centers
- 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.
- Represent MSD at external safety meetings (e.g., PHARMA, etc.)
- Perform other activities as requested by the GS Regional Lead
- The incumbent must have a health, life science, or medical science degree.
- He/she should have at a minimum 3 years of industry experience in pharmacovigilance.
- Must be fluent in English while proficient in local language.
- He/she must also have extensive knowledge of Pharmacovigilance regulations within the country.
- The incumbent must have 2 or more years of supervisory experience if he/she will be managing direct reports.
- The PV Country Lead is expected to have strong leadership, communication, and problem-solving skills, along with a demonstrated ability to build and manage close relationships with key Health Authorities in his/her country(ies). Experience interacting with auditors / inspectors and conducting qualification audits is a plus. This position may require travel globally.
- PV Intelligence
◦knowledge of pharmacovigilance systems & requirements
◦knowledge of pharmacovigilance principles, concepts, practices & standards
◦in depth knowledge of the local country(ies) pharmacovigilance regulations & obligations
◦understanding of risk management
◦basic understanding of Good Clinical Practice concepts
◦Knowledge local country industry code of practice
- People Management (if applicable)
◦ability to identify talent and develop direct reports
◦ability to coach and motivate those undertaking PV activities
◦ability to manage performance of direct reports
◦Resource Management for country of responsibility
◦recruitment of local country PV personnel, if applicable
◦maintain budget for country GS activities
- Communication skills
◾excellent written & spoken English
◾good presentation skills
◾ability to communicate effectively verbally and in writing
◾proficient in local language(s)
◾proficient in Good Documentation Practices
- Computer skills
◾good word processing, presentation & spreadsheet application skills
◾proficient in use of a safety database
◾ability to learn new computer interface systems
◾Strong project management skills with the ability to prioritise assignments
◾Excellent time management, organizational & planning skills
◾High level of accuracy & quality in work
◾Strong collaboration skills with the ability to work across boundaries
◾Strong problem solving capability
◾Sense of urgency and the ability to make rapid, disciplined decisions
◾Good training skills
◾Strong leadership and interpersonal skills
◾Courage and candor
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.
Job: Drug/Dvcs Sfty Survnce (NonMD) Job Title:Assoc. Dir, Drug Safety
Primary Location: LATAM-Peru-Lima-Lima
Employee Status: Regular
Number of Openings: 1
Company Trade Name:MSD
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