Dancing
Aakriti Singh
Sr. Safety and PV Specialist
Gurugram
Summary
Results-driven Senior Safety and Pharmacovigilance Specialist with a robust foundation in specialized tasks and a proven track record of delivering impactful results through targeted initiatives. Expertise in implementing effective strategies that enhance operational efficiency while aligning with team objectives. Strong problem-solving skills and extensive project management experience contribute to successful outcomes in complex environments. Committed to fostering a culture of safety and compliance, ensuring organizational goals are consistently met or exceeded.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Sr. Safety & PV Specialist
Syneos Health
11.2016 - Current
- Mastered case processing activities, including triage and ICSR handling, in alignment with program-specific safety plans and SOPs.
- Conducted triage of ICSRs with strong understanding of seriousness criteria, ensuring accurate prioritization and classification.
- Performed Quality Checks (QC) on all case types to maintain compliance and data integrity across the program.
- Assisted in drafting and reviewing Safety Management Plans (SMPs) as per project requirements.
- Independently generated expedited safety reports (CIOMS, MedWatch, XML) for regulatory submission.
- Provided mentorship and guidance to junior case managers, enhancing team performance and knowledge sharing.
- Participated in Pharmacovigilance audits and inspections, contributing to successful compliance outcomes.
- Delivered sponsor trainings to new and experienced associates, ensuring alignment with safety protocols and expectations.
- Processed ICSRs per SOPs, including coding of adverse events, medical history, concomitant medications, and lab tests.
- Compiled narrative summaries with clinical accuracy and regulatory relevance.
- Assessed and initiated follow-ups for missing or incomplete data, ensuring case completeness and regulatory readiness.
- Demonstrated strong knowledge of global regulations (GCP, ICH, GVP), Work Instructions (WIs), and drug development lifecycle.
- Acted as a liaison between internal teams, sponsors, vendors, and regulatory authorities in safety and pharmacovigilance matters.
- Ensured timely and accurate reporting of expedited cases to sponsors and health authorities in compliance with applicable regulations.
- Collaborated with cross-functional teams to achieve project goals on time and within budget.
- Followed all company policies and procedures to deliver quality work.
- Proactively initiated and managed follow-up communications with healthcare professionals and reporters to gather critical patient data for ICSRs, improving data quality and supporting accurate medical assessment.
Education
M. Pharm - Pharmacology
08.2016
Research Project: "To evaluate the in-vivo effect of needles extract of plant Pinus roxburghii Sarg. using Wistar albino rats."
B. Pharm - undefined
08.2014
Completed one month training in Akums Pharmaceuticals under quality assurance department.
Skills
Effective team player
Flexible in dynamic environments
Ability to meet tight deadlines
Rapid skill acquisition
Client engagement
Quality control
Critical analysis
Root-cause analysis
Advanced problem-solving skills
Emergency response
Certification
Product Manager- ISB-Ongoing certification
EXTRACURRICULAR ACTIVITIES
- Anchored the Dance Event at the National Technical cum Cultural Festival, Mahatma Jyotiba Phule Rohilkhand University
- Active member of Funtoo Activity Team, regularly organizing fun and interactive events at the workplace to boost team morale and foster a positive work culture
Additional Information
Languages: English and Hindi
Technical Skills: Safety database tools (Argus, Mosaic), CATool, CIRE, MedDRA coding, WHO drug dictionary and Company drug dictionary
Recognition: Top performer (Syneos Health), received recognition on timely delivery
Availability: Available to join within 60 days
Interests
Meditation
References
Rekha Pandey [Sr. Safety and PV Specilaist, Syneos Health], [Mob. No.: 08826638619]
Samriddhi Sharma [Manager, Syneos Health], [Mob. No: 8427733396]
Timeline
Sr. Safety & PV Specialist - Syneos Health
11.2016 - Current
Mahatma Jyotiba Phule Rohilkhand University - B. Pharm,
Department of Pharmaceutical Sciences, Kumaon University - M. Pharm, Pharmacology