Senior Compliance Officer

2 weeks ago

Ahmedabad, Gujarat, India beBeePharmacovigilance Full time

At the forefront of pharmaceutical excellence, we pride ourselves on delivering comprehensive clinical research services to the industry. Our specialty lies in supporting pharmaceutical, biotechnology, medical device, and nutraceutical companies throughout every stage of the drug/product development lifecycle.

Key Responsibilities:

• Maintain and organize a highly compliant Pharmacovigilance system with seamless PV business continuity and after hours availability.

• Ensure adherence to established processes and guidelines as well as national and international regulations and guidelines for pharmacovigilance.

• Lead internal and external PV audits and inspections while monitoring PV system performance and compliance of partners and distributors.

• Stay abreast of country and worldwide regulatory changes and promote awareness within the company.

• Spearhead strategic PV activities, ensuring active contribution to the pharmacovigilance system's safety profile.

• Serve as the primary contact person internally and externally for all safety-related aspects and PV operations.

Required Skills and Qualifications:

• In-depth knowledge of national and regional regulatory legislation and guidelines.

• Proficiency in pharmacovigilance regulations across multiple countries.

• Strong organizational, facilitation, and interpersonal skills, enabling effective collaboration in cross-functional teams.

• Skilled people manager, capable of overseeing and controlling outsourced vendor activities in a regulated environment.

• Excellent analytical and problem-solving abilities, with a rational approach to issues and their business implications.

• Highly detail-oriented and organized, with excellent communication and interpersonal skills.

Minimum Requirements:

• At least five years of experience in the pharmaceutical industry, with a minimum of five years in pharmacovigilance.

• A degree or advanced degree in medicine or life sciences, or equivalent experience.

• Excellent verbal and written English proficiency.

• Advantageous: experience in other affiliate medical functions or global clinical product development; Microsoft Word and Excel proficiency.

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