Bausch + Lomb is recruiting for a Pharmacovigilance Specialist position in Mumbai, India. The role focuses on pharmacovigilance, materiovigilance, vendor oversight, individual case safety report (ICSR) quality review, post-marketing surveillance, and medical device safety reporting.
The position involves ensuring compliance with local and international safety regulations, reviewing vendor-processed cases, coordinating with internal and external stakeholders, and supporting Medical Affairs operations.
Job Details
| Particulars | Details |
|---|---|
| Company | Bausch + Lomb |
| Job Title | Pharmacovigilance Specialist |
| Business Function | Global Pharmacovigilance and Risk Management / Medical Affairs |
| Location | Mumbai, India |
| Experience | Minimum 3 years |
| Industry | Pharmaceutical or medical environment |
| Qualification | BS, MS, or Doctorate in Pharmacy, Nursing, a related discipline, or a comparable field |
Position Details
The role is responsible for overseeing vendor case processing and ensuring the quality and regulatory compliance of individual case safety reports and medical device events. The selected candidate will also support drug safety reporting, post-marketing surveillance programmes, medical device vigilance, standard operating procedures (SOPs), training, and regulatory inspections.
Key Responsibilities
1. Vendor Oversight and Case Quality Review
- Review vendor-processed individual case safety reports (ICSRs) and medical device events.
- Monitor weekly and monthly case quality data and identify improvement and training requirements.
- Review adverse event (AE) and serious adverse event (SAE) reports.
- Clarify medical issues, issue queries, confirm case assessments, review narratives, and revise MedDRA terms.
- Review vendor procedures and coordinate with internal medical personnel and external vendors.
2. Pharmacovigilance for Drugs and Quasi-Drugs
- Represent Bausch + Lomb India as the local pharmacovigilance (PV) designee.
- Receive, document, report, enter, follow up, and archive safety information from spontaneous reports, literature, and other sources.
- Perform expedited reporting of ICSRs to local regulatory authorities.
- Review relevant sections of Data Exchange Agreements and manage pharmacovigilance agreements with third-party distributors.
3. Post-Marketing Surveillance
- Oversee applicable post-marketing surveillance (PMS) programmes.
- Coordinate with Regulatory Affairs, Medical Affairs, and Clinical Operations.
- Oversee contract research organisation (CRO) activities in accordance with SOPs, protocols, and regulations.
- Prepare or review study documents, including protocols, case report forms (CRFs), periodic reports, and re-examination applications.
- Report serious adverse event cases to CDSCO India and the global function.
4. Medical Device Safety Reporting
- Prepare adverse event reports for medical devices.
- Manage safety documentation, database entry, follow-up, and archiving.
- Submit adverse event and safety information reports to local regulatory authorities within required timelines.
5. Medical Affairs, SOPs, and Compliance
- Support Medical Affairs activities across products and business units.
- Review promotional materials and support medical information services.
- Coordinate healthcare professional and key opinion leader activities.
- Develop and revise local SOPs and support global or regional vigilance procedures.
- Train employees, vendor support staff, and third-party distributors on drug safety reporting.
- Support vigilance audits, regulatory inspections, deviations, and corrective and preventive action (CAPA) documentation.
Eligibility and Qualifications
Candidates applying for the Bausch + Lomb Pharmacovigilance Specialist position should have:
- A BS, MS, or Doctorate degree in Pharmacy, Nursing, a related discipline, or a comparable field of study from an accredited college or university.
- At least 3 years of experience in pharmacovigilance, materiovigilance, or post-marketing surveillance in the pharmaceutical industry or a medical environment.
- Experience in individual case safety report or medical device event review is preferred.
Required Skills
- Knowledge of global safety, pharmacovigilance, and materiovigilance regulations and guidelines.
- Experience using safety databases, preferably LSMV and CatsWeb.
- Knowledge of general medicine or pharmacy, clinical practice, scientific terminology, and medical terminology.
- Excellent written and verbal communication skills.
- Strong interpersonal skills and the ability to work collaboratively.
- Strategic planning and project management abilities.
- Attention to detail and strong organisational skills.
- Ability to prioritise workflows effectively.
