Lead and manage a team of two safety surveillance specialists (junior and senior level) and a drug safety physician, within the Vigilance Risk Management function of Mundipharma Drug Safety and Pharmacovigilance (MDSP)Lead all aspects of MDSP expert input to project teams and clinical sub teams within R&D organisationDevelop strategies to advance the pain sub-function within MDSP, influencing processes, protocols, studies, data collections, data review, etc.Provide drug safety expertise to the drug safety sections of regulatory documents and submissions (scientific advice meetings, expert reports, common technical documents, etc)Build, maintain and leverage drug safety networks both internally and externally in order to ensure continuous high quality and performanceRepresent MDSP sub-function in international working groups, European and international drug safety meetingsEnsure that safety reporting, signal detection and evaluation, benefit risk assessment for investigational and marketed products is in compliance with international and national regulationsAct as product expert for both investigational and marketed products. This may encompass but is not limited to the following activities: evaluating in-licensing opportunities and support innovation process for new business opportunities and acquisition; clinical trial and post marketing safety surveillance (signal detection, signal evaluation, benefit risk assessment, risk mitigation), review of clinical trial documentation, support to Investigator Brochure (IB) development and IB review; safety surveillance input into compassionate use programmes; integrated Summary of Safety (ISS) review; authoring safety reports (e.g. Developmental Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs); labelling (CCSI, SmPC, PIL)

Lead a Risk Management and Epidemiology teamLead risk management of marketed and investigational products, including pharmacovigilance activities such as PASS, and additional risk minimisation activities, such as educational materialsAdvising, implementing and managing risk management and epidemiology initiatives internationallyEnsuring consistency of risk management strategies as applicableDevelop and implement risk management strategies and provide expert advice to the businessCo-ordinate and lead both an European and a Worldwide Risk Management Group

Project management and authorship of aggregate safety reports (eg. PSURs) in accordance with the new template as per GVP module VIIProject management and authorship of Risk Management Plans also considering the GVP module V requirementsSignal detection and authorship of signal work-up documentsEffective contribution to safety committee meetingsAuthorship of CCDS sections and associated supporting documentationAuthorship of responses to regulatory agency or external customers' safety enquiries Reviewing of global literature for identification of individual case safety reports and potential safety concerns

Act as subject matter expert for suppliers and stakeholders, locally, concerning safety-related issuesLiaise with key partners regarding safety data collection and handlingProvide both internal and external customers information on pharmacovigilance and safety of medicinesTimely response or coordination with the teams involved timely response to customer´s requestsProvide internal training on pharmacovigilance to employees and those with whom the Company contractsManagement of information on Pharmacovigilance and safety of products to ensure maintenance high patterns of AE reporting and guarantee compliance with regulatory requirements; screening of scientific articles of national journals in what regards safety informationCommunicate with the Portuguese Regulatory Authority building up positive relationshipsDevelop and maintain expertise of all Company products, of applicable corporate policies and local regulations, guidelines, Standard Operating Procedures and writing practicesRevision of Pharmacovigilance Agreements within licensing, co-marketing and co-promotion contracts Revision of non-interventional study protocols, market studies and promotional materials in what regards pharmacovigilance section

Perform protocol and site feasibilities for Clinical trials / Non-interventional studies and provide feedback from potential investigators on investigational drug, protocol and site feasibilitiesDevelop and manage a strong and professional relationship with investigators and KOLs based on scientific accuracy, trust and credibilityAct as the reference point of contact to investigators/KOLs; provide to study teams feedback from investigators on study conduct and drug development strategy and leverage interaction between site teams and clinical operations ensuring complete and continuous alignment with product development strategySupport of Investigators on National and International meetings Drive patient’s recruitment and motivate study staff at investigational site by specific protocol and ICH-GCP training activities to Investigators, study staff and all Investigators partners in the respective sitePrepare, submit and discuss with Ethics Committees (both National Ethics Committee and Site’s Ethics Committees), Regulatory Authority and National Committee for Data Protection applications of Clinical trials (phases 2-4)/Non-interventional studies and IIRs; prepare and discuss financial agreements with Institution Administration BoardsSupport on preparation and discussion of country study budgetArrange study logistics at investigational sites; coordinate with internal and external suppliers timely medication supply to Clinical trialsPreparation and training of investigators and other study staff on drug, protocol specifics, SOPs and ICH-GCPsTherapeutic areas of experience: Renal transplantation (Immunosuppression), Rheumatology, Neurology, Endocrinology, HIV-AIDS

Interact with Medical teams and sales representatives to ensure the most accurate and complete collection of information on pharmacovigilance and safety of medicines; maintain high-quality case management ensuring maintenance of high-standard compliance with regulatory requirementsEnsure timely handling of local safety issues; manage local safety issues in collaboration with central safety functions and the local Medical Directors/BU colleaguesProvide both internal and external customers information on pharmacovigilance and safety of medicines; promote local, internal and external safety activities in collaboration with the Medical Directors and BU colleagues Provide internal training on pharmacovigilance to Company employees and those with whom the Company contractsRepresent the Company pharmacovigilance in local industry associations and other external groupsAct as local contact or local Qualified Person for Pharmacovigilance for the Health AuthorityDiscussion, preparation and revision of Pharmacovigilance Agreements within licensing, co-marketing and co-promotion contracts; preparation and revision of local implementation guidelines and working practicesRevision of non-interventional study protocols, market studies and promotional materials in what regards pharmacovigilance section Timely and accurate response to auditors requests within internal audits

Management of a set of external clientsParticipate in meetings to discuss pharmacovigilance services to be contractedPharmacovigilance activities including reception, processing and submission of AEs/SAEs to Regulatory Authorities, screening of scientific journals, preparation of PSURs/ASRs.

Implementation of an Information Service in Compounded Medicines directed to community and hospital pharmacists and consumersPreparation of working procedures and design of the functional activities to better respond to internal and external customer´s requests and develop high-quality services focused on customer’s needsReception and response to information requests from pharmacies and consumersTraining of trainees