Senior Pharmacovigilance Specialist

Locatie: Haarlem, Noord-Holland, Nederland
Salaris: competitive
Sectoren: Life Sciences
Soort functie: Freelance
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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.

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.

Other Activities

  • 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

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.

Qualifications

Background Requirements

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.

Functional competencies

PV Intelligence

  • 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

SkillsCommunication skills

  • 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

Computer skills

  • good word processing, presentation & spreadsheet application skills
  • proficient in the use of a safety database
  • ability to learn new computer interface systems

Personal

  • High level of accuracy & quality in work
  • Excellent time management, organizational & planning skills
  • Strong project management skills with the ability to prioritise assignments
  • Strong collaboration skills with the ability to work across boundaries Compliance mindset/focused Good problem solving capability Good leadership and interpersonal skills
  • Good training skills
  • Courage and candor
  • Sense of urgency and the ability to make rapid, disciplined decisions.

For more information and to apply, please send me your most recent CV + Cover letter to: j.vanbaalen(@)progressive-nl.com

Our client is seeking to have received applications by Tuesday. Feel free to inquire for more information during the weekend.

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