Senior PV Specialist
Currently I am looking for a Senior Pharmacovigilance Specialist for a one year contract for a pharmaceutical company in Haarlem.
Senior Pharmacovigilance Specialist
Pharmacovigilance Country Lead
Summary of Position
The Senior (Sr) 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 and is able to function independently in the processing of adverse events. In the absence of the PV Country Lead, he/she is responsible for overseeing and managing the day-to-day activities of the local country operations Pharmacovigilance Department.
Procedural responsibilities include 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. The Sr PV Specialist acts as back-up for the PV Country Lead and, as requested by the PV Country Lead, the Sr 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 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'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, MSD 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.
Deliver 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.
Train and mentor PV staff, if applicable
Complete and document required PV training within the required timelines.
Liaise with Data Management Centres and Global Safety Global Case Management colleagues at HQ.
Represent MSD at external safety meetings (e.g., PHARMA, etc.)
Perform other activities as requested by the PV Country Lead.
Perform specific delegated tasks from the PV Country Lead
In the absence of the PV Country Lead:
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 in the absence of the PV Country Lead.
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.
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.
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.
- 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
- 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
- good word processing, presentation & spreadsheet application skills
- proficient in the 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
- Sense of urgency and the ability to make rapid, disciplined decisions
- Compliance mindset/focused
- Courage and candor
- Good problem solving capability
- Good training skills
- Good leadership and interpersonal skills
Are you the new Senior PV Specialist? Apply online or to speak to a consultant about this project, contact Lauren Dikmans via +31 (0)20 522 1588 or l.dikmans[at]realstaffing.com