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Pharmacovigilance Specialist Senior

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Brief description :

Pharmacovigilance Specialist Senior (Exp. 4-6 years)  No of Openings- 4​
  • Receipt of incoming case information via project specific mailbox/fax daily OR via an autogenerated SAE notification email from TEMPO and/or designated EDC system per project requirements.
  • Tracking and triage of case information for processing
  • Prioritize incoming AE/SAE/ER information for further processing and confirm receipt, as required.
  • Identify potential 7-Day and 15-Day Alerts
  • Prepares disposition email to notify client of case assessment details (confirmation of serious criteria, expectedness and causal association) as required.
  • Assumes case ownership responsibility for non serious, spontaneous and or serious clinical trial domestic and foreign cases as applicable.
  • Consults with multiple stakeholders (e.g. the sponsor / medical monitor / pharmacovigilance physician) to decide on action and/or additional steps to provide complete narratives to the sponsor.
  • Conduct active follow-up for clarification and missing case details
  • Handling of safety information according to given processes and procedures, by CPWW and/or client SOPs, WPs and Guidelines
  • Enter initial and follow up information in the CPWW safety database or clients database, according to project requirements, as required.  
  • Review and/or perform coding for all required medical/drug terms according to given coding dictionaries and applicable coding guidelines
  • Develop case narratives, per project specific template.
  • Unblind treatment codes in studies, if applicable
  • Create safety line listings as required
  • Provides final narrative and/or CIOMS I form /MedWatch form to the clientafter review by the MM/ SPV
  • Perform/coordinate expedited reporting according to project requirements
  • Possess general working knowledge of local and international PV regulatory frame work
  • Supervising of less experienced PV Pharmacovigilance Specialists (Junior and Regular) in the performance of tasks.
  • Job Requirements:
  • Additonal tasks and responsibilities depending on the level of experience:
  • Data retrieval from safety databases or EDC system
  • Support the work of Pharmacovigilance by generating ad hoc adverse event reports (data retrieval) according to input or by request of Safety Physician
  • Generate validated ad hoc reports as well as periodic reports from safety database as requested
  • Expert for coding (MedDRA and other coding dictionaries)
  • Expert for Argus Safety (System Owner),- Serves as intermediary between Users and IT
  • Maintenance activities for the User Manual of the Argus Safety Database
  • Assistance in Proposal calculation and in preparing requests for information (RFI)
  • Participate in regulatory audits and inspections in cooperation with QA, as needed.
  • Participate and present in bid defense, client, team or investigator meetings (as applicable)
  • Review and preparation of draft working procedures and training materials, providing input to SOPs
  • Clinical Event Committee (CEC) – support, triage cases for adjudicable events, prepare packets for committee review
  • Serve as Responsible Person for EudraVigilance (RP-EV)
  • Registering of company headquarter, affiliates, third party providers and users
  • Assistance

Preferred skills

  • General knowledge of drug therapy, disease states, clinical research.
  • Applies working knowledge of pharmacvigilance processes and requirements to complex situations.
  • Advanced medical knowledge, ability to analyze, draw conclusions, and formulate recommendations related to potential safety issues.
  • Excellent computer knowledge. Use of MS office applications to a competent standard for Word, Excel, and PowerPoint.
  • Sound working knowledge of regulatory reporting requirements and international regulations (EU, US ,Japan and Asia).
  • Experience with team leading roles or comparable leadership functions.
  • Willingness to provide guidance and training to less experienced staff.
  • Willingness for continous on the job training and qualitfications measures.
  • Basic understanding of financial aspects of projects.
  • Practices professionalism and integrity in all actions – demonstrated ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done.
  • Works through conflict and drives productive resolution.
  • Ability to prepare draft working procedures, templates and/or training material
  • Ability to review and provide input for SOPs, working procedures, guidelineAbility to review and give input to Draft Safety Safety Management Plan (SMP)
  • Ability to provide quality control (QC) of scheduled expedited reports within safety database and/or designated EDC system (e.g. TEMPO) as applicable.
  • Ability to process or retrieve safety information, initating searches and/ or generate reports from the safety database or designated EDC system(e.g.TEMPO), as applicable.
  • Ability to maintain and protect client, patient and corporate confidentiality.
  • Ability to work in an environment of rapidly changing priorities and manage multiple client projects.
  • Ability to review medical data from clinical trials and post-marketing experiences, as applicable.
  • Ability to organize and manage work to meet strict timelines.
  • Ability to provide exceptional customer service and professional interactions with a varied customer base, as necessary.
  • Ability to work independently with high reliability and a high sense of responsibility.
  • Ability to work as a member of a team and possession of confident communication skills both written and verbal.
  • Ability to communicate in English (both written and verbal) .
  • Ability to work with careful attention to details.
  • Up to  10 % travel, as needed, for project team meetings, client presentations and other professional meetings/conferences as needed.