Medical Writer II - Orcimed Life Sciences Private Limited - Hyderabad
(2026-01)
Responsible for preparing high-quality regulatory and aggregate safety documents while ensuring compliance with international pharmacovigilance and regulatory requirements. Work closely with safety, regulatory, and clinical teams to deliver scientifically accurate and submission-ready documents within timelines.
- Authoring Periodic Safety Update Reports (PSURs) in compliance with global regulatory guidelines.
- Preparing Aggregate Data Collection (AdCO) Reports.
- Drafting Development Safety Update Reports (DSURs).
- Authoring Clinical Study Reports (CSR) with accurate safety data presentation.
- EURD list review and schedule preparation for upcoming safety reports according to DLP and submission due dates.
- Collaborating with cross-functional teams to ensure timely submission of regulatory documents.
- Performing quality review of safety documents to ensure consistency, completeness, and regulatory compliance.
- Supporting regulatory submissions by maintaining high-quality medical writing standards.
- Monitored and screened global regulatory communications for safety, labeling, and pharmacovigilance updates, including Article 31 Referral Procedure outcomes and scientific conclusions. Assessed the potential impact of regulatory recommendations, communicated relevant updates to internal stakeholders, prepared Minutes of Meeting (MoM) to document discussions and action items, and supported the preparation and maintenance of product labeling in compliance with regulatory requirements.
- Participate in internal and external audits/inspections, as required.
- Perform reconciliation activities for medical writing deliverables throughout all relevant workflows as applicable.
- Strong knowledge of MedDRA, WHO Drug Dictionary and coding.
- Good knowledge and understanding of the standard operating procedures and abiding by the guidelines
Medical Writer - Orcimed Life Sciences Private Limited - Hyderabad
(2025-04 - 2026-03)
- Drafted Periodic Safety Update Reports (PSURs) following global regulatory guidelines.
- Conducted Kick-off Meetings (KOMs) for assigned projects.
- Prepared Minutes of Meeting (MoM) to document project discussions and action items.
- Performed sales data calculations for inclusion in aggregate safety reports.
- Screened global regulatory authority websites for new pharmacovigilance recommendations and safety updates.
- Assessed the impact of regulatory recommendations on existing workflows and documentation processes.
- Coordinated with internal stakeholders to ensure timely completion of deliverables.
- Maintained document quality, consistency, and compliance with client and regulatory expectations.
- Review, assessment and interpretation of Periodic Safety Update Report Single Assessment (PSUSA), Risk Management Plan (RMP), Pharmacovigilance Risk Assessment Committee (PRAC), Co-ordination group for Mutual recognition and Decentralized procedures-human (CMDh) and World Health Organization (WHO) recommendations.
- Formulate and maintain the search strategy/strategies in line with parameters provided by the client to enable accurate and exhaustive identification and retrieval of scientific and medical literature articles from PubMed.
Drug Safety Associate - Orcimed Life Sciences Private Limited - Hyderabad
(2023-04 - 2025-03)
- Performed systematic literature review and screening for identification of safety information.
- Comprehensive assessment and characterization of signals, risks and new safety information
- Conducted signal detection and drafted safety signal reports.
- Evaluated Periodic Safety Update Single Assessment (PSUSA) reports.
- Reviewed and analyzed Individual Case Safety Reports (ICSRs) from EudraVigilance Data Analysis System (EVDAS).
- Assessed safety data from global safety databases for signal identification.
- Reviewed Pharmacovigilance Risk Assessment Committee (PRAC) recommendations and safety communications.
- Performed medical evaluation of identified safety signals.
- Authored signal assessment reports with scientific rationale and regulatory justification.
- Supported ongoing pharmacovigilance activities in accordance with GVP guidelines.
