PV Specialist-Safety Data Exchange Agreements SDEA
PV Specialist-Safety Data Exchange Agreements SDEA
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Job Description
Purpose:
The PV Specialist is responsible to have oversight and management of SDEAs/PVAs for Business relationships in all regions. This includes coordination with various stakeholders business relationship assessment SDEAs/PVAs drafting review & revision for Dr Reddys business relationships ensuring to meet the standard process and applicable regulatory requirements.
Responsibilities:
- To coordinate with various stakeholders involved in Business relationship of all regions to ensure:
- All main agreements are assessed for PV obligations to ensure either a PV clause or a separate SDEA/PVA is required and placed
- Existing SDEAs/PVAs are up to date with respect to the current templates with standard procedures and aligned with current legislation
- Ensuring that all key PV stakeholders are involved to support in drafting review approval and sign off of PVAs with necessary PV obligations based on Business terms regulatory requirements and standard procedures.
- Lead the negotiation process with Business partner for all PVAs with support from Global PV Head Head of PV Operations and Regional PV Heads as needed.
- Ensure all executed PVAs and its Main agreements are tracked within Global Comprehensive tracker and filed within dedicated share folder.
- PVAs Periodic revision: manage the process in set periodic cycle for review and update of existing PVAs to ensure all provisions are up to date with regulatory requirements and standard procedures.
- Periodically reviewing existing PVA templates to align with standard functional process and to design standard templates with the support and approval of Global PV Head and Head of PV Operations.
- Maintain comprehensive contracts Master list and Global PVA Exchange Matrix for all active PVAs and main contracts with PV clause to support the PV functional process implementation.
- Devise and maintain a process for ensuring the implementation of PVAs post signing.
- Monitor ongoing compliance with terms and conditions of PVA and provide updates during internal compliance meetings. Ensure major noncompliance is escalated.
- Provide list of agreements to support generation of the PSMF when required
- Support PV due diligence activities for new product acquisitions/divestments as needed.
- Act as SME for PVA management during audit and regulatory authority inspections
Relationship Management
- Build relationship with key stakeholders Regional PV Leads Business Units and legal as applicable.
- Define practices under the supervision and support of Global PV Head and Head of PV Operations to implement the same.
Process Improvement / Standardization
- Ensure PVA templates keep pace with changes in legislation
- Identify areas of process improvement and propose recommendations
- Support process automation for PVA management including establishing database reporting rules for distribution of ICSRs to partners
- Resolve issues related to PVAs with teams.
Qualifications :
Desired Skills & Competencies
- Knowledge of global regulations including FDA EU & emerging market guidelines.
- Understanding of PV operations to ensure appropriate negotiation of terms in all PVAs
- Demonstrate understanding of commercial agreements with a view to matching the required PV strategy to the commercial relationship
- Previous experience in PVA management
- Excellent teamwork and interpersonal skills
- Excellent time management and organisational skills
Additional Information :
About the Department
Global Manufacturing Organisation (GMO)
At Dr. Reddys Laboratories we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence we are a leading force in the pharmaceutical industry.
We operate 19 stateoftheart manufacturing plants across Hyderabad Vizag Baddi Mexico Shreveport and Mirfield comprising 8 OSD facilities 3 Injectables facilities and 8 API facilities. Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1150 drug master files across key therapy areas such as Oncology Cardiovascular Central Nervous System and AntiDiabetes. The World Economic Forum has recognised our largest manufacturing facility in Bachupally Hyderabad as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive meeting business imperatives and meeting our ambitious ESG goals. Building such factories of the future is integral to innovation and to build healthcare of the future.
Benefits Offered
At Dr. Reddys we actively help to catalyze your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys are on par with the best industry standards. They include among other things and other essential equipment joining & relocation support family support (Maternity & Paternity benefits) learning and development opportunities medical coverage for yourself and your family life coverage for yourself.
Our Work Culture
Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions...
For more details please visit our career website at Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
