PrimeVigilance Hiring Pharmacovigilance Officer Team Lead

PrimeVigilance Hiring Pharmacovigilance Officer Team Lead | Life Science & Pharmacy Candidates | Pune

Professionals seeking advanced pharmacovigilance careers in India have an excellent opportunity with PrimeVigilance. The company is currently hiring for the position of Pharmacovigilance Officer, Team Lead in Pune. This role is ideal for experienced pharmacovigilance professionals who are ready to take the next step into team leadership, ICSR management, drug safety operations, and global pharmacovigilance project oversight.

Candidates with experience in adverse event processing, case management, drug safety surveillance, regulatory compliance, and pharmacovigilance operations will find this position particularly relevant. The role combines technical pharmacovigilance expertise with people management responsibilities, making it suitable for professionals aiming for leadership positions within the pharmaceutical and CRO industry.

Company Overview

PrimeVigilance, part of the Ergomed Group, is a globally recognized pharmacovigilance and regulatory services organization established in 2008. The company provides specialized services across Pharmacovigilance, Medical Information, Regulatory Affairs, and Quality Assurance for pharmaceutical, biotechnology, and medical device companies worldwide.

With teams operating across Europe, North America, and Asia, PrimeVigilance has built a strong reputation for delivering high-quality drug safety and regulatory solutions. The organization supports both emerging biotech firms and large multinational pharmaceutical companies across multiple therapeutic areas.

PrimeVigilance places strong emphasis on employee development, continuous learning, work-life balance, and professional growth, making it an attractive employer within the global drug safety and pharmacovigilance sector.

Job Role & Responsibilities

Pharmacovigilance Officer, Team Lead

The selected candidate will lead pharmacovigilance operations related to Individual Case Safety Report (ICSR) management while supervising assigned pharmacovigilance team members.

Key Responsibilities

Team Leadership

• Line manage assigned pharmacovigilance professionals
• Allocate workloads across team members
• Monitor team productivity and performance
• Support staff development and training
• Ensure compliance with project timelines and deliverables

Pharmacovigilance Operations

• Lead ICSR management activities for assigned projects
• Oversee case processing workflows
• Perform second-level quality control reviews of safety cases
• Support adverse event and serious adverse event management
• Review and manage project trackers and operational metrics
• Ensure timely case processing and reporting

Compliance & Quality Management

• Create and maintain project-specific KPIs
• Monitor compliance with pharmacovigilance procedures
• Support CAPA implementation and process improvements
• Manage pharmacovigilance deviations and escalation activities
• Ensure adherence to global drug safety regulations

Client & Stakeholder Management

• Coordinate with pharmaceutical and biotechnology clients
• Participate in project discussions and operational reviews
• Support effective client communication regarding safety activities
• Collaborate with internal Regulatory Affairs and Quality teams

Additional Responsibilities

• Support Local Contact Person for Pharmacovigilance (LCPPV) activities when assigned
• Perform Person Responsible for Local Screening (PRLS) responsibilities for designated countries or languages
• Contribute to process optimization initiatives
• Assist other departments based on operational requirements

Eligibility / Qualifications

Educational Qualification

Candidates should possess qualifications in healthcare or life sciences disciplines.

Relevant courses include:

B.Pharm, M.Pharm, Pharm.D, B.Sc Nursing, M.Sc Nursing, B.Sc Life Sciences, M.Sc Life Sciences, Biotechnology, Microbiology, Biochemistry, Clinical Research, Medical Laboratory Technology, Healthcare Sciences, Pharmacology, Toxicology, Allied Health Sciences.

Experience Required

• 2–3 years of pharmacovigilance experience
• Prior exposure to ICSR processing and case management
• Demonstrated leadership potential
• Experience handling drug safety databases preferred
• Team coordination or mentoring experience is advantageous

Technical Skills Required

Candidates should have knowledge of:

• Individual Case Safety Report (ICSR) processing
• Adverse Event (AE) management
• Serious Adverse Event (SAE) reporting
• Signal detection concepts
• Pharmacovigilance compliance requirements
• Regulatory reporting timelines
• Case quality review processes
• Root cause analysis
• Drug safety documentation
• Global pharmacovigilance practices

Soft Skills

• Strong leadership skills
• Excellent communication abilities
• Team management capabilities
• Planning and multitasking skills
• Attention to detail
• Stakeholder management
• Time management skills
• Problem-solving mindset

Location & Salary

Location

Pune

Salary

₹8 LPA – ₹14 LPA (Approximate)

Application Process

Interested candidates can apply through the official PrimeVigilance careers portal.

Apply Online

https://jobs.smartrecruiters.com/Ergomed/744000129674063-pharmacovigilance-officer-team-lead-line-management-experience-required-

Important Note

• Candidates should currently reside in Pune or be willing to relocate.
• Applicants who have completed assessments or interviews with the company within the last six months may not be eligible for reconsideration.

Frequently Asked Questions (FAQs)

1. What experience is required for this PrimeVigilance role?

Candidates should have 2–3 years of pharmacovigilance experience with exposure to ICSR processing and drug safety operations.

2. Is team management experience mandatory?

The company prefers candidates who have demonstrated leadership potential or prior team coordination experience.

3. Which qualifications are eligible?

B.Pharm, M.Pharm, Pharm.D, Nursing, Life Sciences, Biotechnology, Pharmacology, Clinical Research, and related healthcare qualifications are eligible.

4. What is the primary responsibility of this position?

The main responsibility is leading ICSR management activities while supervising pharmacovigilance team members and ensuring regulatory compliance.

5. Is relocation required?

Yes. Candidates should either be based in Pune or willing to relocate.

6. What is the expected salary range?

Based on current pharmacovigilance market trends, the estimated salary range is approximately ₹8 LPA to ₹14 LPA depending on experience and skill level.

Summary Table

Company	PrimeVigilance (Ergomed Group)
Department Vacancies	Pharmacovigilance Officer – Team Lead
Qualification	B.Pharm, M.Pharm, Pharm.D, Nursing, Life Sciences, Biotechnology, Clinical Research
Experience	2–3 Years
Location	Pune

Tagged as: pharma jobs in pune