Multinational Healthcare Organization
- 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: firstname.lastname@example.org
Jeanette Jarjoura – Executive Search and Leadership Consultant