Senior Specialist, Aggregate Report Writing

We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.

##Locations: Noida, Mumbai & Hyderabad

Senior Specialist, Aggregate Report Writing


Your Job

• Development, authorship and tracking of Safety Reports (PSUR/RMP/ACOs) to ensure that documents are of high quality, regulatory compliant, and that logistics and distribution are handled in an appropriate and timely manner. Initiates the tracking of commitments and liaises with relevant functions that maintain and monitor the commitments.
• Responsible for the implementation of operational tasks in the field of Safety writing
• Overseeing the service performance
• Mentoring employees enabling them to work independently within timelines, budget, and quality
• To organize the kick off meeting, prepare PSURs & RMP s as per the client s SOPs and working practices, review of the document for medical cohesiveness, characterization of safety concerns, to ensure quality of the draft during preparation of RMP/PSUR/ACOs
• In collaboration with required teams, development and authorship of high quality and regulatory compliant PSUR-PBRER, RMP, ACO & DSURs
• Coordinates activities from the different line units to ensure all documents required to support the RMP/PSUR/ACO main document are included in the annexes
• Manage all logistical aspects related to the timely development of the safety reports, work with authors of the different line functions to ensure the content meets client and Health Authorities requirements.
• Updates the RMP according to HA requirements and make sure they are aligned with other regulatory documents such as the Periodic Safety Update Report (PSUR), CDS, etc.
• Ensure consistency and regulatory compliance of RMP/PSUR/ACO sections and annexes.
• Tracks Health Authorities feedback and assessment on RMP/PSUR/ACO and ensures HA requirements are implemented as required (e.g. in individual RMP, in global RMP template)
• Provides expertise required for the finalization of the RMP/PSUR/ACO and its annexes. Resolve issues as they arise.
• Ensures proper maintenance of all RMP/PSUR/ACO documents as per process
• Develops and dispatches product-specific training slides for both internal and training of 3rd party, and ensure RMP/PSUR/ACO approved by HA or RMP/PSUR/ACO updates are dispatched as per requirement
• Peer-review (data and scientific review) & populate QC checklist
• To address the comments by the various stake-holders
• Preparation of response to questionnaire to address HA request, Evaluation of the safety database/literature/CT data/epidemiology data to address HA response/request
• Formulating strategy for safety issues/response to health authority requests and integrated benefit-risk evaluation
• To address the comments by the various stake-holders

Your Profile

• Experience: Minimum 4 years in Aggregate report authoring (Innovators)
  Qualification: B.Pharm/M.Pharm/BDS/Pharm D