Pv Specialist-safety Data Exchange Agreements

Company DescriptionDr Reddy s Laboratories Ltd is a leading multinational pharmaceutical company based across global locations Each of our 24 000 plus employees comes to work every day for one collective purpose to accelerate access to affordable and innovative medicines because Good Health Can t Wait We started in 1984 with a modest investment 20 employees and a bold vision Today we have research and development centres manufacturing facilities or a commercial presence in 66 countries For nearly four decades we have stood for access affordability and innovation based on the bedrock of deep science progressive people practices and robust corporate governance As the pharmaceutical industry evolves and undergoes disruption we see an opportunity - to strengthen our core further the next steps and to build the future the new bets The Next and the New is how we aim to continue to be the partner of choice - purpose-driven future-ready and sustainable Our aim is to reach over 1 5 Bn patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy Sustainability for us means operating in a manner that respects people planet and purpose - helping us conserve precious resources serve our patients create value for stakeholders give back to society fulfil our potential and maintain our integrity and transparencyDr Reddy s maintains a work environment free from discrimination and is an equal opportunity employer We are committed to employ nurture all qualified diverse workforce without regard to race colour religion nationality sex age disability status genetics sexual orientation gender expression citizenship or any other characteristic or classification protected by applicable law s of the country we operate in We treasure every talent and recognize merit and diversity in our organization 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 Reddy s 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 non-compliance 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 QualificationsDesired 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 InformationAbout the DepartmentGlobal Manufacturing Organisation GMO At Dr Reddy s 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 state-of-the-art 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 1 150 drug master files across key therapy areas such as Oncology Cardio-vascular Central Nervous System and Anti-Diabetes 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 OfferedAt Dr Reddy s we actively help to catalyze your career growth and professional development through personalised learning programs The benefits you will enjoy at Dr Reddy s 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 CultureAsk any employee at Dr Reddy s why they come to work every day and they ll say because Good Health Can t Wait This is our credo as well as the guiding principle behind all our actions For more details please visit our career website at