Grade - SME/TL/TM- RMP

Project Role - RMP author and QC

RMP author and QC - Lead end-to-end authoring, updating, and finalization of RMPs/US PV Plans in compliance with client templates, SOPs, regulatory requirements, GVP guidelines, and agreed timelines.
Collaborate with cross-functional stakeholders by participating in kick-off meetings, consolidating inputs, resolving comments, and proactively following up on pending information.
Ensure high-quality and consistent documentation by validating alignment across document sections, annexes, and supporting source documents (e.g., labeling, clinical/non-clinical data, PSURs, literature, and statistical outputs).
Manage document lifecycle activities, including version control, track-change and clean versions, redacted submissions, system workflows, approvals, e-signatures, and archival of all working files and communications.
Lead QC activities and support preparation of responses to health authority queries, ensuring timely delivery, regulatory compliance, and proper documentation throughout the document lifecycle.

Minimum Educational Qualification - B.Pharm / M.Pharm /Ph.D. /BDS/BHMS/BAMS/Masters in life science

Required Working Experience & Language Competencies -SME: Mimimum 3 years of experience in Aggregate reporting with minimum 2 years of experience in RMP writing in EU template

TL: Minimum 5 years of experience in Aggregate reporting with minimum 3years of experience in RMP writing in EU template

TM: Minimum 7-8 years of experience in Aggregate reporting with minimum 4 years of experience in RMP writing in EU template

Grade- TL/TM -AR MR

Project Role - Aggregate reports medical reviewer





Responsibilities - Provide medical and safety expertise for aggregate reports (DSURs, PBRERs, PSURs, etc.), including participation in kick-off meetings, review of key safety documents, and development of reporting strategies.
Conduct medical review, analysis, and interpretation of safety data, ensuring conclusions are clinically relevant, accurate, consistent, and compliant with regulatory requirements.
Collaborate closely with aggregate report authors and cross-functional stakeholders to address comments, refine assessments, and incorporate feedback from reviewers, QPPVs, and client safety physicians.
Support regulatory interactions by contributing to responses to health authority queries and reviewing safety documents to ensure compliance with global pharmacovigilance standards.
Contribute to training, mentoring, and knowledge-sharing activities for safety physicians and support additional pharmacovigilance activities as requested by the client

Minimum Educational Qualification - MBBS/MD

Required Working Experience & Language Competencies - TL: Minimum 2 years of PV experience in Aggregate report writing and analysis.

TM: Minimum 4 years of PV experience in Aggregate report writing and analysis.

Valid PAN Number - _____________________(Why PAN Required > Mandatory to Process Candidature & Find Duplicity in Internal PAN Validation Process and also to initiate a screening call.

Please reach out in case of any queries.

Sonali Chattopadhyay I Associate People Success

Orcapod Consulting Services Pvt Ltd.

Email I [email protected]

www.orcapodservices.com

(phone hidden)

📌 Team Lead / MR (SME/TL) (Hyderabad)
🏢 Orcapod Consulting Services
📍 Hyderabad