Bristol Labs is a renowned name in the pharmaceutical industry, committed to developing and delivering high-quality healthcare products worldwide. With a focus on safety, efficacy, and regulatory compliance, the company is dedicated to ensuring the well-being of patients through innovative medicines. Bristol Labs is now looking for a skilled Pharmacovigilance Specialist to join its dynamic team and contribute to the ongoing success of the organization.

Responsibilities in the Job: As a Pharmacovigilance Specialist at Bristol Labs, your primary responsibilities will include:

1. Global Pharmacovigilance Compliance: Ensuring adherence to global pharmacovigilance regulations such as those set by the EMA, FDA, and MHRA. You will play a key role in ensuring that the company’s drug safety operations meet all regulatory requirements.
2. Managing PSMF (Pharmacovigilance System Master File): Overseeing the Pharmacovigilance System Master File, ensuring it is up-to-date, comprehensive, and compliant with global standards.
3. Handling SDEA (Safety Data Exchange Agreements): Managing the drafting, negotiation, and maintenance of Safety Data Exchange Agreements with business partners, ensuring compliance with the necessary legal and regulatory requirements.
4. SPC/PIL Submissions: Ensuring that submissions related to Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL) variations are properly managed and aligned with the latest regulatory guidelines.
5. Adverse Event Reporting: Managing the reporting and follow-up of adverse drug reactions (ADRs) and ensuring timely submission of safety data to health authorities.

Qualifications: To qualify for this role, candidates should possess:

1. Experience: A minimum of 3 to 4 years of experience in pharmacovigilance, ideally within the pharmaceutical or healthcare sector.
2. Educational Background: A degree in Pharmacy, Life Sciences, or a related field is preferred. Additional certifications in pharmacovigilance or regulatory affairs would be an advantage.
3. Knowledge: In-depth knowledge of global pharmacovigilance regulations, including EMA, FDA, and MHRA, is essential for ensuring compliance with safety standards.

Skills: To excel in this role, candidates should have:

1. Attention to Detail: Strong analytical and organizational skills to manage multiple safety reports and submissions efficiently.
2. Communication Skills: Excellent verbal and written communication skills to interact with internal teams, regulatory bodies, and external partners.
3. Problem-Solving Abilities: A proactive approach to identifying and resolving issues related to pharmacovigilance and regulatory compliance.
4. Technical Proficiency: Proficiency in using pharmacovigilance databases and tools, along with a working knowledge of safety data reporting systems.

How to Apply: If you meet the qualifications and responsibilities outlined above, and you are passionate about making a difference in drug safety, you can apply for the Pharmacovigilance Specialist role at Bristol Labs. Send your updated resume and a cover letter outlining your relevant experience and skills to Riya.Worlikar@bristollabs.com.