Pharmacovigilance Department – SDEA

Location: R&D, Mumbai
No. of Positions: 1
Experience Required: 2 to 5 years
Qualification: B Pharm/M Pharm/MSc
Role Profile: SDEA

Roles & Responsibilities

• Responsible for managing Safety Data Exchange Agreement (SDEA) globally in accordance with regulatory requirements (including but not limited to writing, reviewing, revision, negotiation, liaising with stakeholders, tracking and archiving, implementation, and compliance etc.).
• Create new SDEA based on the terms and conditions of the commercial agreement and standard Company's SDEA templates. Ensure that all new SDEA contains appropriate PV provisions in accordance with regulatory requirements.
• Liaising with internal global, regional and local key stakeholders (e.g. Safety, Quality, Regulatory, Clinical Research, Business Development, Supply, Marketing, Commercial, Legal, Affiliates etc.) and external business partners in performance of SDEA related activities.
• Coordinate preparation, review, conclusion, approval, sign off, tracking, and archival of all SDEAs.
• Perform Monthly reconciliation with All SDEA partners.
• Devise and maintain a process for ensuring the implementation of SDEAs post-signing.
• Provide list of SDEAs to support generation of the PSMF (annex B and C), when required.
• Support PV due diligence activities for new product acquisitions/divestments as needed.
• Act as SME for SDEA management during audit and regulatory authority inspections.
• Act as a key contact point on all matters relating to SDEAs with internal stakeholders as well as external business partners.
• PV training for ADR reporting to MAH.
• SDEA partner audit questionnaires completion as per request.
• To conduct SDEA related trainings.

Desired Skills & Competencies

• Knowledge of global regulations including: EU, UK, USFDA and emerging market (India, ROW).
• Understanding of PV operations to ensure appropriate negotiation of terms in all SDEAs.
• Demonstrate understanding of commercial agreements with a view to matching the required PV strategy to the commercial relationship.
• Good written and verbal communication.
• Previous experience in SDEA management.
• Excellent teamwork and interpersonal skills.
• Excellent time management and organisational skills.