Senior Project Lead PSS Job at Fortrea in Bangalore. Pharmacovigilance leadership role for experienced drug safety professionals in clinical research India.
Fortrea is currently hiring for the position of Senior Project Lead – PSS in Bangalore. This is a full-time opportunity for experienced pharmacovigilance and clinical safety professionals who want to work in a global CRO environment. The role focuses on leading adverse event management processes and supporting global safety reporting operations across clinical and post-marketing programs.
If you have a strong background in drug safety, clinical research, or pharmacovigilance operations, this role offers excellent exposure to international projects and leadership responsibilities. Senior Project Lead PSS Job at Fortrea in Bangalore
Company Overview
Fortrea is a global contract research organization specializing in clinical development, pharmacovigilance, and regulatory services. The company partners with pharmaceutical and biotechnology organizations worldwide to accelerate drug development and ensure compliance with international regulatory standards.
With a strong presence in clinical safety and lifecycle management, Fortrea offers professionals the opportunity to work on global trials, innovative therapies, and advanced safety systems in a collaborative environment. Senior Project Lead PSS Job at Fortrea in Bangalore
Job Location & Employment Type
- Job Title: Senior Project Lead – PSS
- Company: Fortrea
- Location: Bangalore, Karnataka, India
- Employment Type: Full-Time
- Work Mode: Office-based
- Department: Pharmacovigilance / Clinical Safety
This role is based in Bangalore and may involve occasional travel depending on project requirements.
Department Details
The position falls under the Pharmacovigilance and Patient Safety Services (PSS) division. The team is responsible for managing adverse event reporting, regulatory safety documentation, and compliance activities across clinical trials and post-marketing programs.
The Senior Project Lead will work closely with global clients and internal stakeholders to ensure compliant safety reporting aligned with international guidelines. Senior Project Lead PSS Job at Fortrea in Bangalore
Key Roles & Responsibilities
As a Senior Project Lead in pharmacovigilance, you will oversee safety operations and support project leadership functions. Key responsibilities include:
- Managing receipt and processing of adverse event reports from clinical and post-marketing sources
- Ensuring safety reporting compliance with global regulatory requirements
- Overseeing expedited reporting timelines for assigned projects
- Supporting preparation of pharmacovigilance documents including:
- Individual Case Safety Reports (ICSRs)
- Serious Adverse Event narratives
- DSURs and periodic safety reports
- Aggregate safety reports and line listings
- Acting as safety lead for regional or global projects
- Coordinating database reconciliation and safety data reviews
- Monitoring workflows and ensuring timely deliverables
- Preparing and delivering safety presentations to stakeholders
- Maintaining strong knowledge of SOPs and pharmacovigilance guidelines
- Supporting development of SOPs, work instructions, and templates
- Contributing to Safety Management Plans and reconciliation plans
- Participating in audits and inspection readiness activities
- Supporting safety committee data requirements
- Managing client interactions and cross-functional coordination
- Supporting financial tracking and out-of-scope work identification
- Assisting with Trial Master File (TMF) related activities
- Ensuring data accuracy and quality in safety reporting
This role requires strong technical safety expertise along with leadership and project coordination skills. Senior Project Lead PSS Job at Fortrea in Bangalore
Eligibility Criteria
Education
Candidates with the following educational backgrounds are eligible:
- Bachelor’s or Master’s degree in:
- Pharmacy
- Life Sciences
- Biological Sciences
- Nursing
- Chemistry
Alternative education with relevant pharmacovigilance experience may also be considered.
Experience
Minimum experience requirements depend on educational background:
- 2–5 years of pharmacovigilance or clinical safety experience
- Experience handling adverse event processing and safety reporting
- Exposure to CRO or pharmaceutical environments preferred
Relevant experience may include:
- Drug safety operations
- Regulatory affairs
- Clinical data management
- Medical affairs
- Quality assurance
Candidates with leadership exposure will be preferred. Senior Project Lead PSS Job at Fortrea in Bangalore
Skills Required
Applicants should demonstrate the following skills:
- Strong understanding of pharmacovigilance processes
- Knowledge of global adverse event reporting requirements
- Familiarity with GCP and ICH guidelines
- Experience working with safety databases
- Understanding of medical and drug terminology
- Strong attention to detail and accuracy
- Good communication and presentation skills
- Ability to manage multiple projects simultaneously
- Strong organizational and problem-solving abilities
- Proficiency in MS Office tools
- Team collaboration and stakeholder management skills
Knowledge of medical device reporting is considered an added advantage.
Salary & Benefits
- Compensation will be offered as per company norms
- Potential benefits may include:
- Exposure to global pharmacovigilance programs
- Career growth in clinical safety leadership
- Opportunities to work with multinational clients
- Professional training and development
- Stable career path in CRO industry
Exact salary details are not specified in the job description. Senior Project Lead PSS Job at Fortrea in Bangalore
Selection Process
The recruitment process generally includes:
- Online application submission
- Profile shortlisting
- Technical interviews (pharmacovigilance focus)
- Client or leadership interview (if applicable)
- Final HR discussion
Candidates should be prepared for scenario-based safety questions. Senior Project Lead PSS Job at Fortrea in Bangalore
How to Apply
Interested candidates should apply via the official Fortrea careers portal.
Before applying, ensure your resume highlights:
- Pharmacovigilance experience
- AE/SAE processing exposure
- Safety database expertise
- Experience with global reporting standards
Applying early is recommended due to competitive demand for safety roles.
Important Dates
- Application Deadline: Not specified
Candidates should apply as soon as possible.
Why Apply for This Pharma Job?
Here are some compelling reasons to consider this opportunity:
- Opportunity to lead pharmacovigilance projects in a global CRO
- Exposure to international safety reporting standards
- Strong growth potential in clinical safety leadership
- Work on diverse therapeutic areas and global studies
- Opportunity to interact with global clients
- High demand skillset in drug safety domain
This role is ideal for professionals aiming to grow into senior pharmacovigilance leadership positions. Senior Project Lead PSS Job at Fortrea in Bangalore
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform providing pharmaceutical and healthcare job updates. We are not affiliated with Fortrea or any organization mentioned in this article. Candidates should verify job details through official sources before applying. Senior Project Lead PSS Job at Fortrea in Bangalore
Final Words
Senior pharmacovigilance roles in global CROs offer strong career growth and international exposure. If you have experience in drug safety and want to step into a leadership-oriented role, this Fortrea opportunity in Bangalore could be a valuable move. Prepare a well-structured safety-focused resume and apply early for better chances of selection. Senior Project Lead PSS Job at Fortrea in Bangalore
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