Oferta pracy

Organon - Associate Director Pharmacovigilance & Regulatory Affairs

MSD PolandO firmie

  • Warszawa, mazowieckie

  • Ogłoszenie wygasło miesiąc temu
  • Umowa o pracę
  • Kierownik / Koordynator

MSD (headquartered in Kenilworth, New Jersey, USA) has made the decision to spin-off products from its Women’s Health, trusted Legacy Brands, and Biosimilars businesses to form a new, independent company. This new company, named “Organon”, will become an independent, publicly traded company in 2021 with its global and US headquarters to be based in Jersey City, New Jersey, USA.  We expect that additional Organon sites will be in the general vicinity of current MSD locations.

For this exciting new opportunity, we  are seeking candidates with an entrepreneurial and learning spirit who are interested in a career of purpose, personal growth and leadership.  Working together, we will make a significant impact on the health and lives of people around the world.

 

Organon - Associate Director Pharmacovigilance & Regulatory AffairsNumer ref.: 110221

The Associate Director is responsible for adverse event management including aggregate and individual case safety report (ICSR) health authority submissions, compliance monitoring, and for performing the tasks independently when required. He/she is responsible for managing product registration activities including timely registration of new products & their variations/updates and product license maintenance in the country in accordance with local regulations & global company standards.

 

The Associate Director is also responsible for other activities (as delegated by their manager) which may include but are not limited to: management and negotiation of local PV and RA agreements,
local due diligence activities, participation in audits and inspections and related readiness activities, local initiatives, SOP management, local training, communication of safety issues, developing product registration plans and strategies, people development, o special projects as assigned, and is able to work on these delegated activities independently.

 

The Associate Director may serve as the Qualified Person for PV (QPPV) /Local Responsible PV person (or back-up) as required per local PV legislation.


Organizational Relationships

 

The Associate Director reports to the PV and RA Country Lead, or PV and RA Cluster/Sub- regional Lead and may manage direct reports within the PV and RA team.

Resources Managed (budget and FTEs)

Primary Activities:


  • Serves as the local responsible PV person (or back-up) for the country, where applicable.
  • Oversees all daily PV and RA processes and activities within the countries covered by the country operation.
  • Develops product registration plans & strategies in accordance with local regulations and global standards, working cross-functionally to review & communicate the registration strategy.
  • Establishes and coordinates reconciliation processes of AE reports received from local operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners, as applicable.
  • Coordinates the filing, storage and archiving of safety-related and regulatory affairs data and documentation in accordance with company’s policies and local requirements.
  • Participates in compliance activities and coordinates the preparation of necessary corrective actions locally for late reporting countries covered by the country operation
  • Prepares for audits/inspections for countries covered by the country operation and actively participates in the audit and/or inspection. Provides recommendations of corrective and preventive actions (CAPA) and track CAPA commitments to address findings/observations and monitors until closure.
  • Participates in and supports audits of contractual partners/vendors as necessary.
  • Defines and develops local standards and procedures (in compliance with regional and global standards) for the department, to ensure quality PV and RA data and evaluates processes for potential improvement in efficiency and effectiveness.
  • Develops and maintains local PV and RA controlled documents (i.e., SOPs, training materials) ensuring that they are kept current
  • Proactively identifies procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders.
  • Leads the training of PV and RA staff (including maintenance of the local training matrix and onboarding plans) and supports the required training of the local company staff, distributors, vendors, business partners in the countries covered by the country operation, including training documentation.

Qualification, Skills & Experience

 

The incumbent must have a health, life science, or medical science degree or equivalent by education /experience and be fluent in English (written and spoken) while proficient in local language.

 

He/she should have a minimum of 5 years of industry experience in in pharmacovigilance and/or regulatory affairs and supervisory experience managing people/teams/contractors.
He/she must have in-depth of PV and RA regulations for countries covered by the country operation and be an expert in PV/RA processes and activities.

 

The Associate Director is expected to have excellent communication and time management skills, the ability to interface broadly with colleagues within related functions and cross-functionally and be able to work independently with no supervision except in the most complex of situations.

Primary skills include but are not limited to:

  • Collaboration and Partnering: Demonstrates advanced ability to work in partnership with others (internally and externally) to accomplish quality goals; possesses advanced leadership skills.
  • Communication Skills: Demonstrates advanced communications skills to convey and receive information in English and local language. Demonstrates advanced oral and written communications skills. Demonstrates good presentation skills and ability to adapt presentations to various audiences.
  • Problem Solving: Demonstrates advance skills in problem solving using creative thinking, gathers data from appropriate stakeholders and responds to new, complex or problematic situations to influence organization direction.
  • Strategic Thinking: Demonstrates advanced skills to drive change that enhances processes within the company or cross-functionally that improve quality and /or add value to the business.
  • Project Management: Demonstrates advance skills in the ability to organize work efforts, prioritization of tasks and utilize appropriate resources to deliver or support work products in accordance with timelines and appropriate regulations.
  • Decision Making: Demonstrates advanced skills to utilize knowledge, networks and data to make rapid and appropriate decisions and to determine when escalation of issues is necessary.

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