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Manager

4 months ago

Mumbai, India Unichem Laboratories Limited Full time

Job Responsibilities
Conduct and execute all pharmacovigilance related activities in Unichem lab.
Train PV Team, corporate office, manufacturing plants and other vendors as applicable in timely manner.
Ensure preparation and maintenance of pharmacovigilance documentation and SOPs and train relevant stake holders.
Train the PV team to prepare periodic safety update reports (PSURs) and submitting it to the regulatory authorities and risk management plans (RMPs) contribute to pharmacovigilance matrix to ensure that the PV system is running in compliance with procedure and requirements.
Select, audit, oversight and conduct regular meetings with service providers (vendors and CROs) for PV activities.
Ensure that all PV activities are conducted in accordance with Unichem‘s Lab SOPs and regulatory requirements.
Approve PV agreements (SDEA) with partner companies or service providers.
Provide satisfactory responses to all PV related queries.
Update the scientific information of Unichem Lab products in timely manner.
Work with medical, scientific, clinical, and commercial colleagues to contribute to the strategic product plan.
Support medical affairs function to support commercial launches of new products into the marketplace.
Mentor in writing review article, case study and post marketing study.

Desired Skills
Experience in PV department in a reputed pharmaceutical industry.
Excellent understanding of drug safety regulatory requirements.
Ability to coordinate with internal and external stakeholders.
Excellent communication and presentation skills
Experience in PSURs, PBRERs report writing.
Knowledge of pharma regulatory compliances.
Experience in preparing and reviewing of SOPs.
technical knowledge, review skills, and understanding.
have a good analytical and learning attitude.
to any queries.
communication skills & presentation skills
interpersonal skills & team player.