Pharmacovigilance Associate-Medical Devices

2 months ago

Chennai, India Lifelancer Full time

At ICON its our people that set us apart. Ourdiverse teams enable us to become a better partner to our customersand help us to fulfil our mission to advance and improve patientslives.

Our Own It culture is driven by four keyvalues that bring us together as individuals and set us apart as anorganization: Accountability Delivery Collaboration Partnership andIntegrity. We want to be the Clinical Research Organization thatdelivers excellence to our clients and to patients at everytouchpoint. In short to be the partner of choice in drugdevelopment.

Thats our vision. Were driven byit. And we need talented people who share it.

Ifyoure as driven as we are join us. Youll be working in a dynamicand supportive environment with some of the brightest and thefriendliest people in the sector and youll be helping shape anindustry.

Roles Responsibilities:

  • Review and processing Medical Device CaseReports such as serious adverse events/Serious adverse deviceeffect and Device deficiencies/Device incidence received fromvarious sources Clinical trials Post Market etc. and othermedically related information in Safety database or by completingmanual regulatory forms per assigned tasks and study specificprocedures for Medical Device Projects.
  • CodingAdverse Events in accordance with the applicable standarddictionary (MedDRA and IMDRF)
  • Perform orSupervise periodic reconciliation of adverse event and/or qualitycomplaint cases within the required deadlines.
  • Quality Control of activity as applicable
  • Conducts literature surveillance in the selecteddatabase(s) as outlined in the project scope of work and as perestablished procedures
  • Provide input andreview relevant safety tracking systems for accuracy and qualityand assist with maintaining project files
  • Perform safety review of clinical and diagnostic data forcase processing
  • Assist with generation ofregulatory reports as necessary to ensure regulatorycompliance.
  • Liaise with other ICON departmentsinvestigational site reporter and/or Sponsor as necessary regardingsafety issues
  • Assist with coordination ofinterdepartmental activities (e.g. listing review quality controlquality assurance (audits) miscellaneous projectactivities)
  • Responsible for effective andefficient development of the Safety Management Plan includingdevelopment of specific processes to assure consistency within theproject.
  • Supports creation of the SAE/AEreconciliation plan and supports SAE reconciliation in accordancewith this plan and other project specific guidelines.
  • Assures consistency of plans with client contract andidentifies out of scope activities promptly andaccurately.
  • Serve as Functional Lead on caseprocessing or medical information projects as assigned; coordinatesteams of Pharmacovigilance associates on project level and servesas the Pharmacovigilance point of contact for projectteams.
  • Effectively maintains the safetydatabase and corresponding entry guidelines including assurance ofquality of data following established quality controlprocess.
  • Generates data listings from thesafety database and assumes responsibility for accuracy of thedata.
  • Supports analysis and quality controlduring the generation of Aggregated Safety Reports (e.g.Development Safety Update Report IND Annual Report Periodic SafetyUpdate Reports and other Quarterly summary reportpreparation)
  • Supports Safety Scientist insignal detection and risk management activities.
  • Supports interim data analysis for DMCreviews.
  • Participates in internal and clientproject team meetings including presentation of the safety processat kickoff and investigator meetings.
  • Reportsproject status (including monthly metrics) to project/functionalmanagement within agreed upon timelines.
  • Adheres to financial and administrative processes such asmanaging project budget and timelines estimation of resource needsand projected hours.
  • Proposes solutions forprocedural and technical issues.
  • Supportsaudits and inspections as required for the assignedprojects.
  • Serves as subject matter experts forcase processing and/or medical information tasks in a projectteam.
  • Perform other activities as identifiedand requested by management including but limited to:
  • Respond and process medical information inquiriesincluding inquiries related to adverse events/reactions and productcomplaints for Clients product(s) as per their agreement withICON
  • Effectively coaches and mentors lessexperienced Pharmacovigilance associates.
  • Actsas Subject Matter Expert in departmental initiatives.
  • Contributes to business development efforts in DeviceSafety including presenting safety services at bid defensemeetings.

Requirements:

Having knowledge in the Materiovigilance/MedicalDevicevigilance such as Medical Device standards ISO 14155;ISO20916. Guidance: (MDCG 202010) MDCG (20244) and Individual andaggregate reporting regulations EU MDR 2017/745 and EU MDR 2017/746and US FDA 21 CFR part803.

Lifelancer( ) is a talenthiring platform in Life Sciences Pharmaand IT. The platform connects talent with opportunities in pharmabiotech health sciences healthtech data science and ITdomains.

Please use the below Lifelancer linkfor job application and quickerresponse.

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