Regulatory Affairs and Pharmacovigilance Jobs at Ferring Pharmaceuticals

Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. Ferring is a leader in reproductive medicine and women’s health, and in specialty areas within gastroenterology and urology. Ferring employs approximately 6,500 people worldwide, has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.

Post : Senior Executive / Assistant Manager - Regulatory Affairs & Pharmacovigilance

Job Description:
• Compilation and submission of dossier for clinical trial applications, new drug applications, registration applications, renewal applications, post approval change applications and Test license applications for development projects; address queries from the regulators and obtain the approvals
• Responsible for creating & updating Regulatory & Pharmacovigilance SOPs, product artworks, prescribing information, Regulatory & Pharmacovigilance database
• Responsible for obtaining documents and certificates for regulatory submission and Tendering process, from various stakeholders
• Co-ordination with Internal stakeholders including Global Regulatory Affairs, production sites, other functions and external partners
• Responsible for monitoring the safety mailbox, data entry of all types of individual case safety reports, safety reporting, maintenance of Pharmacovigilance records and acting as Deputy Local Safety Officer

Candidate Profile
• B.Pharm essential, M.Pharm desirable
• Overall experience of 10 to 12 yrs
• Experience in filing New Drug & registration applications with CDSCO is essential.
• Experience in filing applications to State FDA desirable
• Knowledge of filing registration applications in Srilanka, Bangladesh, Nepal, Bhutan, Pakistan is desirable
• Knowledge of Pharmacovigilance handling desirable
• Strong computer skills/ proficiency in MS Office applications.
• Excellent attention to detail & accuracy in work essential
• In-depth knowledge of Drugs & Cosmetics Act & Rules essential.
• Ability to work well independently as wellas in a team environment.
• Effective time management skills andability to prioritize workload.
• Fluency in English (written and verbal)

Required Competencies
• Action Oriented
• Interpersonal Savvy
• Organizing
• Perseverance
• Planning
• Process Management
• Drive for Results
• Customer Focus
• Learning on the Fly
• Organizational Ability
• Cross Cultural Sensitivity

Additional Information
Qualification : B.Pharm, M.Pharm
Location : Ferring India M&S
Experience : 5+ years
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Affairs & Pharmacovigilance
End Date : 30th May, 2021