Aggregate Report Writer PSUR & DSUR

Required Skills:

SAR & SAR-like Patient Safety Physician Summary The SAR & SAR-like Patient Safety Physician plays a critical role in ensuring the safety and integrity of pharmaceutical products by leading the medical and safety evaluation of individual case safety reports (ICSRs) and aggregate safety data. This role involves comprehensive analysis of safety trends identification of potential signals and collaboration with therapeutic leads to assess and mitigate risks. The physician contributes to regulatory compliance supports product lifecycle safety monitoring and ensures timely accurate and high-quality safety reporting. Their work directly impacts patient safety regulatory adherence and the overall risk-benefit profile of marketed therapies. Responsibilities Compile and review Periodic Benefit-Risk Evaluation Reports (PBRERs) with a focus on medical and safety content including thorough analysis of source data based on defined queries. Identify analyze and interpret safety signals from individual case reports and aggregate data to support early detection of emerging risks. Collaborate with Therapeutic Area Heads to evaluate safety concerns assess potential causal relationships and recommend appropriate actions. Support cross-functional teams by providing medical insight and contributing to safety discussions during internal and external reviews. Ensure timely and accurate documentation of safety findings in accordance with regulatory and client-specific standards. Advanced degree in medicine (MD or equivalent) with postgraduate training or experience in pharmacovigilance clinical pharmacology or a related medical field. Proven experience in patient safety pharmacovigilance or clinical safety monitoring within the pharmaceutical or biotech industry. Demonstrated ability to analyze complex safety data and communicate findings effectively to multidisciplinary teams. Strong understanding of global regulatory requirements (e.g. ICH E2B FDA EMA) and safety reporting standards. Proficiency in using safety databases and data analysis tools relevant to pharmacovigilance. Competencies Exceptional presentation and communication skills with the ability to convey complex medical and safety information clearly and concisely. Proven ability to work effectively across diverse cultures and global teams. Highly organized and process-driven with a strong commitment to meeting deadlines and maintaining documentation accuracy. Skilled in collaborative problem-solving and contributing to team-based safety assessments. Measurable Goals Achieve 100% compliance with all required client and Cognizant trainings on schedule. Maintain 100% adherence to the work allocation plan including timely case closure and consistent delivery against quality benchmarks. Non-Measurable Attributes Self-motivated and proactive in addressing safety challenges. Focused on achieving objectives with a results-oriented mindset. Demonstrates strong interdepartmental collaboration and cross-functional engagement. Maintains professional appearance and conduct at all times. Consistently punctual and reliable in meeting commitments. Acts as a team player with a structured process-driven approach to work.