LCP - Local Contact Person for Bulgaria

Position Local Contact Person (LCP) – Pharmacovigilance (Freelance/Consultant) Role Overview The Local Contact Person (LCP) will serve as the designated local pharmacovigilance representative, acting as the primary point of contact between the Client, the relevant Health Authority or Agency (where applicable), and Shudarsana Company. The LCP shall ensure timely communication and support local pharmacovigilance activities in accordance with applicable regulatory requirements and client procedures. Key Responsibilities Act as the official Local Contact Person (LCP) for pharmacovigilance activities within the assigned country or region. Serve as the primary communication channel between the Client, local regulatory authorities or agencies (where applicable), and Shudarsana Company for pharmacovigilance-related matters. Receive, collect, and promptly forward any adverse event reports, product quality complaints with safety implications, medical information related to safety, or other pharmacovigilance communications received from patients, healthcare professionals, regulatory authorities, or agencies to the Client and Shudarsana Company within the required timelines. Maintain confidentiality of all information received while performing LCP duties and comply with applicable data privacy and pharmacovigilance requirements. Cooperate with the Client and Shudarsana Company in fulfilling local pharmacovigilance obligations and respond to requests for information as required. Perform only those activities that have been assigned and authorized by the Client or Shudarsana Company. Work Allocation All work assignments shall be communicated to the LCP prior to the commencement of the activity. The scope of work, expected deliverables, and timelines will be provided by the Client or Shudarsana Company before each assignment. The LCP shall acknowledge acceptance of the assigned work before initiating the activity. Training The Client shall provide the necessary training on its pharmacovigilance system, procedures, and applicable tools prior to assigning operational responsibilities. Training sessions shall be scheduled with prior notification to the LCP. The LCP is responsible for attending all mandatory training required to perform the assigned activities. Compensation The LCP shall be compensated on an hourly basis for work performed or specifically allocated by the Client or Shudarsana Company. Hours eligible for payment shall be those approved or assigned by the Client or Shudarsana Company. In months where no operational work is assigned or performed, the LCP shall receive the agreed monthly retainer fee to ensure continued availability for Local Contact Person responsibilities, subject to the terms of the service agreement. Communication Responsibilities The LCP shall immediately notify both the Client and Shudarsana Company of any pharmacovigilance-related communication received from patients, healthcare professionals, regulatory authorities, or other agencies. All safety information shall be communicated within the timelines specified by the Client's pharmacovigilance procedures. The LCP shall maintain accurate records of communications and activities performed when required by the Client or Shudarsana Company.