Pharmacovigilance Manager - local responsible Person for PV in Serbia

PharmaSwiss, part of Bausch Health Companies, is one of the leading pharmaceutical companies in Serbia, that has been marketing its own and third-party products for many years now, while nurturing strong customer-oriented and consumer-centric approach in its everyday business. As a result, we are very proud of our strong reputation among healthcare professionals and consumers. Our goal is to make this leading position even stronger for years to come.

We are currently recruiting for the role of:

Pharmacovigilance Manager, Local responsible Person for PV in Serbia (one position)

Responsibilites:

Local responsible Person for Pharmacovigilance (LPPV)

• Establishing, implementing, and managing the Marketing Authorisation Holder's pharmacovigilance system in accordance with relevant corporate procedures, Safety Data Exchange Agreements and/or local regulations for pharmacovigilance and materiovigilance.
• Ensure creation/update of pharmacovigilance (PV) related local SOPs/Working Instructions, CV, JD, and local Organization Chart on a regular basis or if required.
• Monitoring the safety profile, all safety issues and continuous overall assessment of pharmacovigilance and materiovigilance for all products with a MA in the Republic of Serbia and for products that do not have MA in Serbia, but are imported as “patient-name” program and forward all information to the manufacturer/partner.
• Back-up arrangement, 24/7 coverage and Business Continuity: acting as local pharmacovigilance and materiovigilance contact person for local Competent Authorities (CAs) as required; 24/7 availability for EEA QPPV and local CAs if required.
• Report to EEA QPPV Office: communicate any urgent safety issues, collect and complement requested data for PSMF as applicable, provide monthly reports, ad hoc reports and other requested information
• Intake, if applicable translation and forwarding of Adverse Events (AEs; concerning medicinal products, cosmetic product, biocides, food supplements - as applicable), medical device incidents with or without product technical complaint and special situations with or without product quality complaint and/or medical inquiries to GPRM or partner (as applicable); documentation, partial evaluation, quality check and tracking of AEs and special situations as applicable; reconciliation activities, archiving plus documentation.
• Submission of ICSRs to local CAs; documentation hereof if applicable. 
• Perform/organize local literature search (journals not listed in Embase); maintain, check and update list, documentation of local literature search.
• Oversight of local literature screen vendor (if applicable). 
• Perform follow-up activities as applicable and document
• Create, maintain, update and terminate local PV agreements (including local PV contractors) in cooperation with the Global PV Agreements Team, if required.
• Support review of global PV agreements that involve LPPV’s territory/affiliate in cooperation with the Global PV Agreements Team.
• Inform the Global PV Agreements Team of all executed new, amended or terminated local agreements.
• Perform all activities needed to ensure pharmacovigilance compliance with local and EU legislation, Corporate Procedures and Partner companies' Policies and procedure for all products from BHC and partner portfolio (according to SDEA).
• Support of compilation of aggregate reports by providing requested data (to GPRM or partner) if applicable.
• Maintenance of translation/distribution/documentation of local aRMM and other risk minimization activities according to RMP (in cooperation with Global Risk Management Team, other departments, and partner, as applicable).
• Support submission/acknowledgment of the RA submission of aggregate reports/RMP/aRMM to local CAs; documentation hereof if applicable.
• Participate in safety-related actions (e.g., withdrawals, recalls) if applicable. 
• Check for changes in the local regulatory environment and inform GPRM including EEA QPPV Office (check of local CA website, also for ICSRs, if applicable) in case of relevant new safety information.
• Participate in GPRM training activities, regular online meetings organized by EEA QPPV Office.
• Organize pharmacovigilance and materiovigilance trainings for local affiliate employees including sales representatives as applicable.
• Organize pharmacovigilance training for local contract partners (e.g., distributor) if applicable.
• Act as a local contact point for audits and inspections and related processes and inform Global PV QMS & Compliance Team and EEA QPPV Office.
• Manage/assist in managing pharmacovigilance and materiovigilance audits and inspections from external regulatory agencies, partners, or corporate auditors.
• Prepare documentation for presentation during pharmacovigilance and materiovigilance audits/inspections and prepare and give guidance for staff (process owners) for an interview with auditor/inspector.
• Prepare and manage QE and CAPA documents. 
• Archive pharmacovigilance related documents according to the local CA requirements. 
• Support labeling update activities, maintenance of Reference Safety Information if applicable.
• Collaborate with Medical Affairs/Regulatory Affairs/Quality/Marketing and business departments.
• Perform relevant activities defined by quality assurance system at local affiliate related to pharmacovigilance or materiovigilance.
• Support preparing response to local CAs' requests.
• Reference: AflO_RFWkyi0krJdfX_S3o72gfVVg0jlFOtXbWXrHUF5V7OKQAceTRCPbgOAKsBW

Manager, GPRM

• Coordinate the finalization of documents such RMPs/REMS, PSURs and DSURs and ad hoc requests from regulatory agencies.
• Assist in the preparation of CCSI/CCDS for newly approved products, products in late-stage development, and established company products (both generic and proprietary).
• Conduct signal detection and analysis activities, ensuring that safety signals are appropriately managed and tracked. Identify potential signals and validate. Contribute to analyses in external databases using data mining methods for detection and evaluation of safety signals.
• Prepare/support preparation of signal assessment or other signal related document, and ad hoc requests from Competent Authority.
• Perform aggregate safety data report.
• Support the finalization of regulatory documents such as RMPs/REMS, PSURs, DSURs.
• Participate in creation of Health Hazard Evaluations (HHEs) and respective documents in close cooperation with other involved departments.
• Provide strategic and proactive safety inputs into clinical development plans including protocols, CSRs, IB and informed consent. 
• Maintain pharmacovigilance expertise, understanding of international safety regulations and guidelines. Develops, communicates, and implement best practices, SOPs, templates, work instructions, etc. as called for or specified in assigned tasks and projects.
• Liaison with internal stakeholders, all GPRM Teams (including EEA, QPPV office), Medical Affairs, Regulatory Affairs, Clinical Affairs, Quality, Legal, General Manager, regional and local persons for Pharmacovigilance, relevant local departments, third-party providers for Pharmacovigilance and Risk Management as well as other third-parties, external vendors and Competent Authorities.
• In case of information on Adverse Event or Adverse Reaction, for all the products, included in company portfolio, from any source, immediately or within 24 hours to inform the local pharmacovigilance responsible person, according to local Legislation and the approved internal procedures of the company

Requirements for the role:

• University Degree in Pharmacy
• Strong written and spoken English (mandatory) 
• Minimum 5 years’ experience in pharmacovigilance
• Understanding of Local and International pharmacovigilance regulations including GVP and requirements.
• Strong organizational skills, detail oriented, ability to adapt in a fast paced constantly changing environment.
• Good interpersonal skills