Essential Duties and Responsibilities : To author / draft aggregate reports like PBRER, PSUR, PADER, DSUR Hands on experience in authoring / drafting Risk management plan (RMP) and Risk Evaluation and Mitigation Strategy (REMS) To perform quality review of aggregate reports, RMPs & REMS To draft / author safety assessment reports (SARs) To update RMP / REMS Hands on experience in handling regulatory queries with respect to aggregate reports, RMPs & REMS.
Thorough knowledge on interpreting the various line listing documents Knows the metrics of pharmacovigilance with respect to aggregate reports Independently draft the entire safety documents Preparation of PSMF (Pharmacovigilance System Master File) Hands on experience in preparing and managing aggregate report calendars and follow-up with relevant stake holders for documents and coordination as per the reporting timelines.
Experience with in depth knowledge of pharmacovigilance and understanding on various health authority requirements with respect to aggregate reports.
Well versed and updated on regulatory guidelines. Preparation of Pharmacovigilance / aggregate report Standard Operating Procedures (SOPs) and Work Instructions.
Hands on experience in managing aggregate report projects independently taking client benefit and regulatory requirement into consideration.
Experience in clear and crisp interactions with clients. Specialized knowledge and skills : Basic competence with medical and therapeutic terminology.
Proven ability to analyze and interpret aggregate patient safety data relating to drug products Ability to work independently but guided by documented procedures, with appropriate support.
Proven ability to interpret and follow the patient safety guidelines of the FDA and comparable international regulatory organizations such as the International Conference on Harmonization Proven experience and report writing skills in accordance with agency requirements for content, format and timelines.
Able to work effectively as part of a team. Understanding of patient safety regulatory obligations. Should be familiar regulatory &Pharmacovigilance guidelines.
Should be familiar with Pharmacovigilance terminology. Excellent attention to detail. Ability to deliver within established timelines.
Fluency in English and excellent comprehension. Computer literate. Relevant product and industry knowledge. Experience with relevant software applications.
Communication skills : Requires a proactive approach and excellent written / oral communication and interpersonal skills.
Strong interpersonal skills required to interact with clients, management, and peers effectively. Effective cross departmental communication.
Ability to document and communicate problem / resolution and information / action plans. Desired Technical skills : Person should be familiar with MS Office Tools.
Extensive knowledge of US, ICH, and EU PV and GCP regulations Excellent strategic decision-making and analytical skills Safety database knowledge Other skills : The ability to contribute to a team environment with a high degree of professionalism and skill.
Demonstrate flexibility within a dynamic, fast-paced, cross-functional team. Demonstrated ability to complete multiple tasks concurrently and deliver results in a fast-paced environment.
Ability to perform under stringent timelines. Compliance : Awareness of organizational policies & procedures governing his / her job responsibilities.
Awareness and compliance of QMS & ISMS policies & procedures and their impact at his / her job level. Should understand escalation matrix and escalate to the next level whenever incidents happen which are not in compliance with organizational, QMS & ISMS policies and procedures.
Working Conditions : Normal office environment. Hours : Standard Hours 40 hours per week, one-hour lunch, Monday Friday.
Additional hours as needed. Willing to work in shifts as and when needed