Macleods Pharmaceutical Ltd is hiring experienced professionals for three roles in the Pharmacovigilance Department at its R&D facility in Andheri, Mumbai. The openings are for Safety Variations, SDEA, and Website Review & Compliance Report Activity.
Job Details
| Job Details | Information |
|---|---|
| Company | Macleods Pharmaceutical Ltd |
| Department | Pharmacovigilance |
| Location | Andheri, Mumbai |
| Number of Roles | 3 |
| Qualifications | M.Pharm, B.Pharm, BDS, BHMS |
| Application Email | adityab@macleodspharma.com |
Positions Available
1. Pharmacovigilance โ Safety Variations
Experience: 3 to 5 years
Roles & Responsibilities
- Update SmPC and PIL for Europe and UK as per requirements including PRAC, CMDh, CHMP and Signal.
- Search regulatory websites for new updates, including EMA, MHRA, EC decision and HMA.
- Coordinate with the Regulatory Affairs (RA) department regarding innovator information, common text and queries.
- Review and monitor regulatory updates for safety-related changes.
- Search for country-specific innovators.
- Regularly compare and review SmPC/PIL for Europe and UK as per SOP.
- Identify changes to be filed, update the RSI, and send it to the RA team.
Educational Qualification: M.Pharm, B.Pharm, BDS, BHMS
2. Pharmacovigilance โ SDEA
Experience: 3 to 5 years
Roles & Responsibilities
- Manage Safety Data Exchange Agreements (SDEAs) globally in accordance with regulatory requirements.
- Handle SDEA writing, review, revision, negotiation, stakeholder coordination, tracking, archiving, implementation and compliance.
- Create new SDEAs based on commercial agreement terms and company SDEA templates.
- Ensure SDEAs contain appropriate Pharmacovigilance provisions according to regulatory requirements.
- Liaise with internal global, regional and local stakeholders and external business partners.
- Coordinate preparation, review, conclusion, approval, sign-off, tracking and archival of SDEAs.
- Perform monthly reconciliation with all SDEA partners.
- Maintain a process for implementation of SDEAs after signing.
- Provide SDEA lists to support PSMF Annex B and C generation when required.
- Support PV due diligence activities for new product acquisitions and divestments.
- Act as an SME for SDEA management during audits and regulatory authority inspections.
- Act as a key contact for SDEA-related matters with internal stakeholders and external business partners.
- Conduct PV training for ADR reporting to MAH.
- Complete SDEA partner audit questionnaires as requested.
- Conduct SDEA-related training.
Desired Skills & Competencies
- Knowledge of global regulations including EU, UK, USFDA, India and ROW.
- Understanding of Pharmacovigilance operations.
- Understanding of commercial agreements and PV strategy.
- Good written and verbal communication.
- Previous experience in SDEA management.
- Excellent teamwork and interpersonal skills.
- Excellent time management and organisational skills.
Educational Qualification: M.Pharm, B.Pharm, BDS, BHMS
3. Pharmacovigilance โ Website Review & Compliance Report Activity
Experience: 2 to 3 years
Profile
Website Review and Compliance Report Activity
Roles & Responsibilities
- Conduct daily website reviews for countries including Europe, UK and ROW countries, such as Kazakhstan, South Africa, Ukraine, India and WHO.
- Check safety-related updates and share relevant information with stakeholders, including case-related updates with the Case Processing team, PSUR updates with the PSUR team and signal updates with the Signal team.
- Update SOPs as per requirements and guideline updates.
- Coordinate with QPPV and LRP for queries, training and related activities.
- Archive emails and documents as per process requirements.
- Collect relevant data from stakeholders for compliance report drafting, including case data, PSUR data and signal data.
- Draft compliance reports according to the template and SOP and share them with relevant stakeholders for review.
- Conduct meetings with QPPV for compliance discussions.
- Draft MOM and track action items from relevant stakeholders.
Desired Skills & Competencies
Knowledge of global regulations and guidelines, including:
- GVP Module
- MHRA guidelines for Pharmacovigilance
- EU guidelines
- UK guidelines
- USFDA guidelines
- Emerging market guidelines including India and ROW
- Australia guidelines
- Canada guidelines
Educational Qualification: M.Pharm, B.Pharm
Eligibility & Qualifications
The educational qualifications mentioned across the three positions are:
- M.Pharm
- B.Pharm
- BDS
- BHMS
The Website Review & Compliance Report Activity role specifically requires M.Pharm or B.Pharm.
The Safety Variations and SDEA positions require 3 to 5 years of experience, while the Website Review & Compliance Report Activity position requires 2 to 3 years of experience.
Application Details
Experienced candidates interested in these Pharmacovigilance opportunities at Macleods Pharmaceutical Ltd, Andheri, Mumbai can send their applications to:
Email: adityab@macleodspharma.com