Persolkelly India is actively seeking a skilled Pharmacovigilance Assistant for a leading pharmaceutical company in Mumbai. With a focus on ensuring drug safety and compliance with regulatory standards, this role is critical for maintaining the safety and efficacy of pharmaceutical products in the market. Join our team to embark on a rewarding career that contributes to public health and safety.
Responsibilities in the Job
As a Pharmacovigilance Assistant, you will support Local Safety Operations (LSO) in various vigilance activities, including but not limited to:
- Maintaining Vigilance Systems: Ensure the local vigilance system’s quality, including managing Standard Operating Procedures (SOPs), audits, inspections, and record management.
- Safety Information Management: Oversee the receipt, follow-up, reconciliation, documentation, and submission of safety information to local authorities in compliance with regulations.
- Monitoring: Conduct thorough monitoring of literature, digital media, and social networks to identify safety reports concerning the pharmaceutical products.
- Aggregate Safety Reports: Assist in the preparation and submission of aggregate safety reports to local authorities.
- Signal Management: Help manage safety signals and notify any trends affecting the benefit-risk profile of products.
- Post-Marketing Studies: Conduct and oversee various post-marketing studies, ensuring compliance with regulatory standards.
- Safety Data Exchange Agreements: Maintain agreements with local Vigilance Agreement Partners (VAPs).
- Training: Provide vigilance training to affiliate and local VAP employees, ensuring training records are accurately maintained.
- Collaboration: Maintain relationships with local authorities, VAPs, and Business Units to facilitate efficient communication and compliance.
Qualifications
To be considered for this role, candidates should possess the following:
- Experience: A minimum of 6 months to 2 years of pharmacovigilance experience in the pharmaceutical or biotechnology sector.
- Regulatory Knowledge: Demonstrated knowledge of local and global vigilance regulations and submission requirements. Familiarity with medical device vigilance and cosmetic regulations is an added advantage.
Skills
The ideal candidate should exhibit the following skills:
- Analytical Skills: Strong analytical skills with a keen attention to detail to address issues, questions, and data accurately.
- Project Management: Good project management and problem-solving skills, coupled with excellent time management and negotiation abilities.
- Interpersonal Skills: Strong interpersonal skills to effectively collaborate and communicate with team members and external stakeholders.
- Self-Starter: A proactive self-starter capable of working independently as well as collaboratively within a team.
- Team Player: Commitment to fostering a positive team environment and assisting with workload peaks.
How to Apply
If you meet the above qualifications and are excited about the opportunity to work in pharmacovigilance, we encourage you to apply. To submit your application, please send your resume to Meenakshi Dixit at meenakshi_dixit@persolkelly.com.
