Pharmacovigilance Operations Specialist 1

Job Description

Job Title: Pharmacovigilance Operations Specialist 1Job Location: Trivandrum, India or any remote location in IndiaJob Overview: The Pharmacovigilance Operations Specialist 1 (POS-1) primary responsibility is SAE case management. This includes but is not limited to: initial case disposition, confirmation of case disposition with Medical Monitor (MM) / Safety Physician Pharmacovigilance (SPPV), receipt of adverse event data, data entry, source document data extraction, draft narrative development, follow-up management and reporting according to regulatory requirements. All activities will be in accordance with Clinipace and/or client SOPs, ICH Guidelines and local regulatory requirements. Job Duties and Responsibilities:

• Receipt of incoming case information via project specific mailbox/fax daily OR via an auto generated 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 Clinipace and/or client SOPs, WPs, and Guidelines
• Enters initial and follow up information in the Clinipace safety database or client s database, according to project requirements, as required.
• Reviews and/or performs coding for all required medical/drug terms according to given coding dictionaries and applicable coding guidelines
• Develops case narratives, per project specific template.
• Unblind treatment codes in studies, if applicable
• Creates safety line listings as required
• Provides final narrative and/or CIOMS I form /MedWatch form to the client after review by the MM/ SPV
• Performs/coordinates expedited reporting according to project requirements
• Possesses general working knowledge of local and international PV regulatory framework
• Provides oversight/support to less experienced PV Pharmacovigilance team members (PV Associates and Junior PV Specialist) in the performance of tasks

Additional tasks and responsibilities depending on the level of experience:

• Data retrieval from safety databases or EDC system
• Supports the work of Pharmacovigilance by generating ad hoc adverse event reports (data retrieval) according to input or by request of Safety Physician
• Generates validated ad hoc reports as well as periodic reports from safety database as requested
• Expert for coding (MedDRA and other coding dictionaries)
• Fully proficient in the use of Argus Safety
• May provide assistance in preparing requests for information (RFI)
• Participates in regulatory audits and inspections in cooperation with QA, as needed.
• Other tasks as required

Supervisory Responsibilities:No Supervisory responsibilitiesJob Requirements:

• Education:
  • Degree in life science or nursing/pharmacy qualification or other advanced or equivalent appropriate healthcare or pharmaceutical industry experience or education, e.g. laboratory experience.
  • Medical Documentalist, Medical Documentation Assistant, Nurse with extensive clinical experience or life science degree (e.g. natural scientist with a degree in biology, pharmaceutical medicine of similar specialty) preferred.
• Experience:
• At least to 2-3 years experience in the tasks and responsibilities performed by a Junior PVS Specialist.
• Advanced proficiency in use of safety database and/or EDC system (per client directive).
• Advanced knowledge of medical terminology.

• Deep understanding of drug development and safety data processing and working processes.
• Basic knowledge of international PV relevant rules and regulations (for clinical trial, post-marketing surveillance and/or medical devices)
• Skills/Competencies:
• General knowledge of drug therapy, disease states, clinical research.
• Basic 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).
• Willingness to provide guidance and training to less experienced staff.
• Willingness for continuous on the job training and qualifications 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 resolutions
• Capabilities:
• Ability to review and provide input for SOPs, working procedures, guideline.
• Ability to review and give input to Draft Safety Management Plan (SMP)
• Ability to provide quality control (QC) of scheduled expedited reports within safety database and/or designated EDC system, as applicable.
• Ability to process or retrieve safety information, initiating searches and/ or generate reports from the safety database or designated EDC system, 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 records 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 5% travel, as needed, for project team meetings, client presentations and other professional meetings/conferences as needed.

#LI-Remote V2The company will not accept unsolicited resumes from third party vendors.,

Keyskills :
data entryargus safetyquality controldata processingclinical trialsdata extractionmedical recordsdrug developmentsafety management