Senior Executive- Patient Safety: SDEA and PSMF

Locations --
Mumbai, India
Business Area/Department --
Medical Affairs
Contract Type --
Permanent

Pharmacovigilance activities

Act as a Safety contact point on all matters relating to Safety agreements with license business partners including the handling of confidential information and negotiation of the agreements with commercial and co-development partners.

Coordinate the preparation and conclusion of SDEAs together with relevant internal and external parties. Track and maintain oversight on all assigned Safety agreements.

To update SDEAs on a regular basis, coordinate in the completion of business partner responsibility tracker, to identify gaps in the templates and process, make appropriate changes if required.

Act as a key contact point on all matters relating to SDEAs with internal stakeholders (e.g. Safety, Quality, Regulatory, Business Development, Supply, Commercial, Legal) as well as external business partners.

Accountable for authoring global and regional PSMF and ensuring ‘up to date’ and accurate content.

Maintenance of the PSMF annexures and core body on a regular basis.

Ensure review, documented QC, approval and finalisation of the PSMF according to ADVANZ PHARMA’s procedures.

Actively coordinate with all the internal and external stakeholders to ensure Pharmacovigilance and regulatory compliance.

Participate in the preparation of drafts for Standard Operating Procedures (SOP) and Work Instructions (WI) to ensure consistency, allocation of responsibilities, accuracy, timeliness and implementation.

Involvement in pre and post action arising from PV audits and inspections

Effective management of outsourced PV service provider

 

GENERAL PHARMACOVIGILANCE:

 

Keep abreast of changing PV regulations across the Globe.

Actively coordinate with all the internal and external stakeholders.

Participate in the generation of Standard Operating Procedures (SOP) for the same

Ensure all documentation is structured and maintained as required

 

KEY ACCOUNTABILITIES:

 

Coordinate the preparation and conclusion of SDEAs together with relevant internal and external parties.

Accountable for authoring global and regional PSMF and ensuring ‘up to date’ and accurate content.

key contact point from patient safety team with internal and external stake holders.

 

PERFORMANCE STANDARDS:

 

Compliance with GPvP requirements, demonstrated through audits and inspections.
Support to the business and provision of documentation within agreed timeframes.
Successful relationships with all external partners.
Address internal and external inspection findings.

 

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