Medical Director – KSA (Saudi National)

The Company

Multinational Healthcare Organization

Job Responsibilities:

  • Ensure that all activities and interactions are conducted in line with applicable local, global and national laws, regulations, guidelines, codes of conduct, company policies and accepted standards of best practice.
  • Develop & maintain professional and credible relationships with key opinion leaders and academic centers to ensure access to current medical and scientific information on the products and areas of therapeutic interest.
  • Develop & maintain scientific expertise of company products and related therapeutic areas.
  • Foster collaboration and partnering between opinion leaders and the company.
  • Obtain feedback and advice about company products through peer-to-peer interactions and advisory boards.
  • Identify and develop speakers for the company’s TAs & products.
  • Identify investigators appropriate for clinical trials.
  • Act as investigator-initiated research proposals by facilitation proposal, approval, completion, presentation, and publication of studies Keep abreast of cutting edge research and literature in therapeutic area.
  • Assist in the initiation, oversight and follow up of assigned clinical studies and medical projects initiated within the relevant therapeutic: all activities to comply with applicable local laws, guidelines, codes of practice, SOPs, and Global Pharmaceutical Research and Development (GPRD) SOPs.
  • Ownership of pre-launch, launch & post-launch medical activities (BD, new products assessments, market research programs, advisory boards, experts’ insights meetings, PSP, screening programs…)
  • Conduct medical and product training for medical representatives (Initial training, Refreshment sessions, preparation of quizzes and assessments of all TAs)
  • Maintenance and follow-up on the review and approval of medical / scientific promotional materials till the release to the market.
  • Deliver credible presentations on scientific matters to physicians (individually or in groups meetings, clinical sessions, RTDs etc.), where requested.
  • Participate in the selection process to identify appropriately qualified physicians the Company would wish to engage in collaborative efforts – such as potential research collaborations, or lecture/meeting support (Round Tables, Congresses, etc.); and to ensure a high level of scientific or educational integrity in these collaborative efforts.
  • Ensure Proper documentation for various medical activities; PSAs, medical research & sponsorships.
  • Assist in developing awareness and understanding of competitor issues/intelligence – for example, product strategies, studies, commercial messages, positioning, etc. – and communicate, where appropriate, within the Company.
  • Upon request, assist physicians to appropriately direct requests for access to Company products on a named patient or compassionate use basis, subject to all applicable legal and regulatory requirements.
  • Support sales/marketing/internal team areas to develop their scientific and technical expertise through the delivery of scientific update presentations.
  • Ensure up to date knowledge of products uses and external data.
  • Provide key opinion leaders and internal medical and clinical teams with scientific and technical support for publications of scientific or medical interest.
  • Follow up on Remediation tasks & CAPA execution & closure.
  • Pharmacovigilance Responsibilities :
  • Manages Adverse Events: Processes adverse-event case reports and conducts follow-up; notifies regulatory agencies and business partners accordingly; responds to requests from regulatory agencies; reviews scientific literature and bibliographic sources; helps draft and manage periodic safety update reports; evaluates safety profiles; ensures document filing and archiving
  • Process Individual Case Safety Reports (ICSRs), including data entry in OSYRIS safety database
  • Ensure following-up on ICSRs with the reporter, generate follow up (FU) queries and send FU requests
  • Carry out ICSR local regulatory reporting, perform expedited reporting (including electronic reporting) and periodic reporting
  • Perform ICSRs reconciliations with business partners & other departments
  • Review literature screening search results, identifying ICSRs and other safety-related findings.
  • Write PSURS & RMPS for Local Product
  • Local Adaptation of PSURs (Developing National Appendix)
  • Local Adaptation of RMPs (Developing National Displays)
  • Handle all MOH PV Submissions
  • To assist with pharmacovigilance processes, Trainings, supporting preparation of SOPs, product safety reviews as required
  • Involved in clinical trial activities: reviews the pharmacovigilance aspects of protocols and other documents; ensures management of adverse-event case reports; reconciles information in pharmacovigilance and clinical research databases
  • Assures compliance of pharmacovigilance activities; conducts case reconciliation with concerned departments or business partners.
  • Develop/Follow-up on the SDEA & PV contracts.

Requirements & Qualifications:

  • Bachelor’s Degree in Medicine/Doctorate Degree/Ph.D./Pharm D/M.D or advanced clinical degree is a must.
  • Minimum 5 years of relevant managerial experience.
  • Solid knowledge of the pharmaceutical environment and excellent skills to set stake-holders relationship.
  • Management, Communication and Compliance and Process Improvement Skills.
  • Keen interest in developing and maintaining expert knowledge for assigned therapeutic area/product and in medical research in general.
  • Knowledge of the scientific methods applied to clinical research and the current legislative/regulatory controls.
  • Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity.
  • Proficiency in English language.
  • Excellent presentation skills

If you know of anyone who has these qualifications and is looking for a challenging career, please email: contactus@envisionpartnership.com

Jeanette Jarjoura – Executive Search and Leadership Consultant

Job Category: Director
Job Type: Full Time
Job Location: Riyadh – KSA

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