Drug Safety Specialist, Aggregate Reporting

Job Description

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

Keyskills :
drugsafety safety case reporting dataentry msofficetools stronginterpersonalskills standardoperatingprocedures environmentalimpactassessment msoffice reportwriting writingskills patientsafety riskmanagement riskevaluation workeffectively