Abhimanyu Singh
TEAM MANAGER, MEDICAL WRITING
H. No. 2/2390/17, Gill Colony, Near Thana Sadar, Saharanpur,Uttar Pradesh
Summary
Innovative and goal-oriented professional offering more than 4 years of extensive leadership experience in Medical Writing industry with expertise in projects strategic planning and operational excellence to promote organizational efficiency and customer satisfaction for repeat business. More than 5 years of experience in preparation, coordination, and review of Periodic Safety Reports (PSRs) and narrative writing for pharmaceutical products/vaccines in accordance with client conventions and ICH guidelines.
Overview
10
10
years of professional experience
8
8
years of post-secondary education
Work History
TEAM MANAGER, MEDICAL WRITING
PAREXEL INTERNATIONAL
Chandigarh, Chandigarh
04.2023 - Current
- Oversee transition and execution of new projects, ensuring delivery compliance within budget, meeting regulatory requirements, and ensuring highest levels of client satisfaction.
- Identifying new business opportunities, building relationships with clients, and expanding organization’s client base.
- Assisted with preparation and implementation of 2 pharmacovigilance agreements and contracts.
- Experience in handling more than 10 onsite and offsite client and regulatory authorities' inspections and internal and external audits.
- Developing and implementing strategic plans for organization, annual goals setting and objectives for team members, assessing individual performance and achievements per company HR processes, and ensuring that organization is on track to meet its targets.
ASSOCIATE TEAM MANAGER, MEDICAL WRITING
PAREXEL INTERNATIONAL
Chandigarh, Chandigarh
01.2020 - 03.2023
- Handling operational efficiency and managing 15-20 members team covering onboarding/offboarding, trainings compliance, quality scorecards, KPIs, CAPAs, internal and external communications, monthly billing, and annual salary structuring.
- Hiring and interviewing more than 100 candidates for planning work capacities and managing workload and resource allocation.
- Developing and reviewing more than 15 client Standard Operating Procedures (SOPs) and functional area procedures under “LEAN” project.
- Streamlined more than 10 workflows by identifying bottlenecks in existing systems and proactively addressing these challenges through appropriate solutions implementation.
- Responsible for people development, talent management, assessing individual performance and achievements.
PHARMACOVIGILANCE SPECIALIST & ANALYST
PAREXEL INTERNATIONAL
Chandigarh, Chandigarh
09.2014 - 12.2019
- Experienced in preparation and Quality review of more than 300 PSRs for Pharmaceutical products and vaccines including Periodic Benefit Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Reports (PADERs), Addendum to Clinical Overviews (ACOs), Corporate Addendum Reports, Semi-Annual Safety Reports (SASRs), Benefit-Risk Evaluation (BRE) sections, and checking of International Non-proprietary name (INNs) for inclusion in PSR in accordance with client requirements/conventions and Standard Operating Procedures (SOPs).
- Expertise in writing and quality check of more than 500 Serious Adverse Events (SAEs) narrative writing.
- Supported signal detection activities by conducting ongoing monitoring and analysis of safety data from various sources.
- Mentoring and training of more than 50 members on aggregate report writing on various client procedures and processes.
- Provided subject matter expertise to support development of training materials, standard operating procedures, and work instructions within department.
- Exceeded inspection readiness targets through meticulous record-keeping and adherence to SOPs.
Education
Master of Science - Human Genomics
National Centre of Human Genome Studies & Research
Panjab University, Chandigarh 08.2011 - 08.2013
Bachelor of Science (Honours) - Bioinformatics
GGDSD College
Panjab University, Chandigarh 07.2008 - 07.2011
Senior Secondary School (12th Standard) - Science Education
Rainbow School (CBSE Board)
Saharanpur, Uttar Pradesh 05.2005 - 05.2007
Secondary School (10th Standard) -
Rainbow School (CBSE Board)
Saharanpur, Uttar Pradesh 04.2004 - 05.2005
Skills
Stakeholder Management
undefinedAccomplishments
- Recognized by Country Safety Head for participation in Parexel Medical Writing Training Program and won 3rd prize for Parexel India Annual Awards 2021 in the category for “Driving India’s Mission and Vision”.
- Awarded certificate of recognition in Quarter Q3 – 2021 by Parexel Executive Vice President, Global Safety Services.
- Successfully delivered in Business defence meetings and request for proposals from operational point and business continuity.
Timeline
TEAM MANAGER, MEDICAL WRITING
PAREXEL INTERNATIONAL
04.2023 - Current
ASSOCIATE TEAM MANAGER, MEDICAL WRITING
PAREXEL INTERNATIONAL
01.2020 - 03.2023
PHARMACOVIGILANCE SPECIALIST & ANALYST
PAREXEL INTERNATIONAL
09.2014 - 12.2019
Master of Science - Human Genomics
National Centre of Human Genome Studies & Research
08.2011 - 08.2013
Bachelor of Science (Honours) - Bioinformatics
GGDSD College
07.2008 - 07.2011
Senior Secondary School (12th Standard) - Science Education
Rainbow School (CBSE Board)
05.2005 - 05.2007
Secondary School (10th Standard) -
Rainbow School (CBSE Board)
04.2004 - 05.2005
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