Work as Pharmacovigilance Deputy Manager at Piramal Pharma

Piramal Pharma Solutions is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms.

Post : Deputy Manager - Pharmacovigilance

Roles and Responsibilities
• Preparation and review of aggregate reports (PADER and PSURs) for products approved for human and veterinary use as per applicable regulations.
• Draft Risk Management Plan (RMP).
• End to end case management, including case receipt, database entry, peer review and submission to applicable regulatory authorities within stipulated time. Perform and monitor literature for company molecules.
• Coordination with different stakeholders for data request etc. for fulfilment of Pharmacovigilance responsibilities.
• Coordination with different stakeholders for data request etc. for fulfillment of PV related activities.
• Ensuring compliance with all company SOPs, procedures, and local privacy related regulations.
• Participating in Pharmacovigilance inspections by regulatory agencies such as FDA, MHRA and EMA.

Competencies
• Authoring of aggregate safety reports like PADERs, PBRERs.
• Good communication and interpersonal skills, both written and verbal
• Ability to manage multiple concurrent tasks
• Proven ability to meet strict deadlines
• Ability to work independently and in a team environment
• Competent in use of desktop applications: Microsoft word, excel and PowerPoint

Candidate Profile
• Bachelors/ Masters degree in Pharmacy
• Overall, 3-5 years of experience in Preparation and review of various safety reports,
• Literature screening and authoring of aggregate safety reports like PADERs, PBRERs etc

Additional Information
Experience : 3-5 years
Qualification : Bachelors/ Masters degree in Pharmacy
Location : Kurla, Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Pharmacovigilance
End Date : 20th April 2025