Pharmacovigilance Services Specialist

 About The Role  

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance

Designation: Pharmacovigilance Services Specialist

Qualifications:MBBS/MD

Years of Experience:7 to 11 years

What would you do? Responsible for medical review and assessment of seriousness, causality and labeling of adverse events within agreed timeframes and to a high standard of accuracy, in compliance with Client standard operating procedures and global regulatory requirements.

What are we looking for? Educational and Experience Requirements:?¢MBBS (Medical degree)?¢Technology skills:experience with MS office, knowledge of safety database ?¢Good knowledge of medical terminology including knowledge of applicable dictionaries like MedDRA and WHO-Drug preferred.?¢Good medical writing skills ?¢Good Communication Skills ?¢Strong English Language proficiency (Reading, Writing, Listening and Speaking).Key performance indicators:?¢Ability to learn quickly and contribute to process improvement initiatives in consultation with management.?¢Consistent demonstration of company values/behaviors.?¢ICSRs are evaluated accurately and reviewed within the required timeframes to meet regulatory requirements.?¢Performs all work in accordance with all established regulatory and compliance and safety requirements.?¢Successfully complete and clear all applicable trainings within required timelines

Roles and Responsibilities: ?¢Prioritize medical review for Individual case safety report (ICSRs) in accordance with Client Guidelines, Regulatory due date and turn around me (TAT) service level agreement (SLAs) and key performance indicator (KPIs).?¢Verify and confirm on the selection of adverse events, appropriate MedDRA coding, seriousness, labeling, causality of adverse events and provide a company causality comment as per client SOP.?¢Review the source documents and narrative to assure medical accuracy pertaining to the case is appropriate and entered Global Safety Database.?¢Write company causality comment and route the case to applicable workflow as per Client SOPs?¢Constantly update domain and operations skills as per the changing client requirements by reading the updated version of SOPs?¢Lead the training of internal and cross-functional team members.?¢Actively involved in case discussion with client and provide the valuable inputs to the team.?¢Confirm and advise on the medical assessment queries from case processing associate, literature reviewers, quality reviewers and triage associates.?¢Validate data consistency and update the relevant database fields for any changes as needed in accordance with Client SOPs?¢Determine if any additional information is needed for clarification, or if any follow-up is necessary, and take all relevant steps to obtain any additional/missing information as stated in the relevant Client SOP.?¢Consult global safety physician for additional inputs on the case as required by client SOP.?¢Create action items in global safety database to ensure case details are sufficient for medical evaluation and route the case back for updating as per Client SOP.?¢Perform self-review for changes made to case during medical review and E2B validation check for all cases before routing to next workflow.?¢Respond to queries from internal teams, clients, license partners, regulatory authorities in a timely manner.?¢Contribute to maintenance and compliance oversight of PV processes and contribute to preparation and internal training on adverse events reporting.?¢Other essential duties include drafting pharmacovigilance agendas and meeting minutes, accurately archiving pharmacovigilance documents, reviewing safety case data and other pharmacovigilance documents for completeness and accuracy.?¢To perform assist and contribute in transition of related activities as per the client requirement.?¢To provide relevant approval as per SOP/SWI if needed.?¢Open to get trained and moved across roles based on business requirement.
 Qualification MBBS,MD