Piramal Life Sciences Limited (PLSL) is an independent research-driven drug company that was recently demerged from Piramal Healthcare Limited (Formerly known as Nicholas Piramal India Limited). PLSL was formerly the NCE R&D division of NPIL. PLSL has state-of-the-art R&D laboratories built over 200,000 square-feet of space in Mumbai, India and over 300 scientists engaged in drug discovery and development.
Pharmacovigilance Jobs at Piramal Life Sciences
Piramal Life Sciences Limited (PLSL) is an independent research-driven drug company that was recently demerged from Piramal Healthcare Limited (Formerly known as Nicholas Piramal India Limited). PLSL was formerly the NCE R&D division of NPIL. PLSL has state-of-the-art R&D laboratories built over 200,000 square-feet of space in Mumbai, India and over 300 scientists engaged in drug discovery and development.
Post : Head – Pharmacovigilance
Job Responsibilities:
- Provide leadership to PV team and act as expert in anesthetic, narcotics and anti-emetics for inhalation and especially injectable products marketed in US, US, Europe and ROW region.
- Expertise in handling MHRA, FDA and other regulatory PV inspections.
- Provide leadership in integration of PV activity for acquired products.
- Provide expertise in assessment of PV impact and activity for any prospective products.
- Act as process owner and ensure Individual case reporting & Periodic Reporting Globally (including PSURs, PADERs, PBRER, Annual Reports, Line listings etc.).
- Ensure the development, update, and maintenance of standard operating procedures (SOPs), working instructions, templates, and forms for Global pharmacovigilance department.
- Develop and update training materials for Pharmacovigilance and ensure training of team and other stakeholders on relevant drug safety procedures for AE reporting.
- Ensure Preparation of RMP and signal management for products.
- Maintain managerial oversight of issues and escalate it to senior management when required.
- Ensure preparation of Safety Data Exchange Agreements with business partners as applicable.
- Contribute to inspection readiness documentation including Summary of Pharmacovigilance systems.
- Participate in Leadership team meetings to set and achieve the strategic objectives along with the specific goals and objectives.
- Act as back up medical reviewer.
- Keep PV compliance on track and systems to be audit ready at all point in time. Successful outcome of regulatory audits on PV and compliance to previous CAPA.
- Continuous improvement of Pharmacovigilance system of the organization
Essential Qualifications:
Minimum of a Graduate or post graduate degree in medical sciences – MBBS/ MD or equivalent.
Essential
Skills & Experience:
Should have 15+ years of experience in similar field / industry. Candidates should have experience in either Pharma companies or Pharma Consulting companies.
Should have sound knowledge in anesthetic, narcotics and anti-emetics for inhalation and especially injectable products marketed in US, US, Europe and ROW region.
Should have handled / faced MHRA, FDA and other regulatory PV inspections
Planning and organizational skills – prioritization, resource allocation, multi-tasking.
Proficiency in speaking, comprehending, reading and writing English and Hindi is required
Experience in collaborating with Cross border stakeholders will be preferred
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