Country Safety Head

2 weeks ago

Dubai, Dubai, United Arab Emirates Biogen Full time

Job Description:

About this role:


As Country Safety Head (CSH) you are the primary Pharmacovigilance (PV) point of contact for the local territory, fulfilling the regulatory mandated role of the Local Qualified Person for Pharmacovigilance (LQPPV) in the Gulf Cluster affiliate hybrid based in Dubai.

You are responsible for the end-to-end setup, operation, management and oversight of local PV tasks in compliance with all applicable local regulations, guidance and global business requirements.

Therefore you are in this role acting as a key strategic partner for the local business and provide valued consult and collaboration to all affiliate stakeholders and global functions to support local, regional and global objectives.

The CSH also contributes to the Global and Regional PV strategy as required and reports to the Director Drug Safety.


What you will mainly do:

  • You are accountable for establishing and maintaining a local/regional PV structure and related practices in compliance with local Regulation and in synergy with Biogen's Global PV system.
  • Act as the local/regional expert in all matters pertaining to PV within the postmarketing space and the aligned territory and provides strategic and operational consult to the local business. Contribute to PV matters in the Clinical space as required in collaboration with other GSRS functions.
  • Responsible for establishing optimum and harmonized processes for the receipt, collection and submission (as applicable) of Individual Case Safety Reports (ICSRs) for Company products from any source. Ensures procedures related to Literature Screening and ICSR Followup are in place.
  • Where applicable you ensure Health Authority submission compliance of Aggregate Reports; maintain an uptodate knowledge of local regulatory requirements for Aggregate Reporting and effectively communicates all related Regulatory intelligence to the International Pharmacovigilance (IPV) team and other GSRS functions as concerned and collaborates as required.
  • You maintain awareness of all Organised Data Collection Programs (ODCPs), Extended Access Programs (EAPs), Compassionate Use (CU), Registries, Digital and Social Media Activities that are relevant to the local territory; ensure appropriate PV Processes are in place; ensure adherence with the Global PV Governance structure and procedures.
  • Where local signal management is mandated by local Regulation, you oversee and manage the process to ensure compliance; collaborate with GSRS teams as required to address any outcomes and concerns.
  • Create and maintain the local Pharmacovigilance System Master File (PSMF)/ National Pharmacovigilance System File (PVSF) in accordance with the GVP requirements and as appropriate internal business processes. Ensure that the local PSMF/PVSF are kept up to date and ready for submission to local authorities at all times.
  • Maintain a constant state of inspection readiness by maintaining appropriate documentation/evidence that demonstrates the efficient and compliant functioning of the local PV structure. Acts as the lead PV contact (and hosts where needed) local Pre and Post-Marketing inspections throughout the inspection lifecycle.
  • As is applicable the CSH is also responsible for the fulfillment of LQPPV Responsibilities as per local regulation; The LQPPV ensures there is comprehensive understanding of these specific responsibilities at the Local, Regional and Global level, in order to enable compliance with regulatory expectations for the role.

Who you are:


You have obtained a minimum of 5 years prior in-depth knowledge of Global, Regional and local PV regulations and requirements.

Well-developed technical writing skills with the ability to produce clear, concise documentation and communications. Good presentation and analytical skills. Excellent Project Management skill and you must have worked effectively/collaboratively in a fast-paced and matrixed environment.

You demonstrate effective managerial skills, are a self-starter, have ability to adapt - to work independently or as part of a team, goal oriented, attention to detail and accuracy, and ability to multi-task and prioritize.

Able to demonstrate innovative thinking.

Qualifications:

Required Skills:

  • Minimum of bachelor's level degree, in pharmacy or medicine
  • 5+ years in drug safety/pharmacovigilance in pharmaceutical industry setting or the equivalent for Sr. Manager Level above
  • Experience with interacting with third parties (e.g. PV operations vendors) required
  • Knowledge of Good PV Practices, direct experience in GxP compliant quality systems preferred
  • Prior gained experience with Adverse Events Intake systems as well as in writing procedures, training materials and effectively delivering training to a diverse audience
  • Experience (e.g. interviewee, control room, document request) of Audits and Regulatory Inspections preferred.
  • Strong decisionmaking skills required, must demonstrate initiative

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