Safety PV Specialist II/ Principal PV Spl (11 months of Contract role, Mumbai)

Description

Safety PV Specialist II/ Principal PV Spl (11 months of Contract role, Mumbai)

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression supportive and engaged line management technical and therapeutic area training peer recognition and total rewards program.
• We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Job Responsibilities

• 8 Months Contract Role

• Candidates from Mumbai preferrable

• Min 4 yrs of relevant experience required

• Immediate joiners preferred

Assist the CSH to collect and report ADRs/AEs and other safety relevant information.

. Periodic Safety Report (PSR) Management: o Local periodic reports are handled in compliance with PSPV Quality Documents (QDs/SOPs) and local regulatory PV requirements.

• To assist in preparing local PSRs if and when required.

• Contribute together with PSPV and Regulatory Affairs (RA) department to the planning for periodic safety reports.

• Planning, tracking and monitoring of Master Planning Table and Affiliate Tracking Table (ATT) activity.

• Patient Program (PP) and Managed Access Program (MAP) Management: o support PP/MAP approval with validation of documents, ensure PP/MAP vendor PV training done before PP/MAP initiation and regular refresher trainings, as and when required.

• Monthly review of PP/ MAP vendor QC and reconciliation activity

• Perform regular audit of the QC check activity performed by vendor

• In case of local product in-licensing or local company acquisition: Participate, in close collaboration with GPE, in the due diligence and integration process as per available Company standards.

• In case of local agreements with pharmaceutical companies (license-in, license-out, co-marketing-co-promotion, divestment.), a local SDEA is in place and implemented, aligned with the local regulations and Global SDEA standards and regularly revised.

• That global SDEAs are implemented locally when applicable.

• Monthly validation of agreement with PV clause/SDEA with relevant stakeholders

• Complete global Business plan requirements (BPPQRA activity)

• Maintain MyAlliance database with latest and updated documents and information.

• Ensure appropriate PV requirement in contracts for all types of service agreements, Purchase Orders (PO's) (where applicable), etc.

• Maintain schedule and conduct PV awareness, PV refresher and PV induction training, as and when required.

• All safety-related questions raised by local Health Authorities are collated and immediately transmitted by e-mail to the GSO of the concerned GPE Business Unit and to the relevant GPE mailbox for evaluation and organization for further immediate communication within GPE and action as relevant.

• Product safety alerts are handled in accordance with company product alert processes. Local PV Alerts are managed and coordinated in collaboration with GPE, the relevant medical director and local Management.

• Assist in management of Product Recall

• Develop and maintain the local Pharmacovigilance System File (LPSF) in accordance with the global standards and local legislation.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary

Performs safety and pharmacovigilance program delivery activities including (but not limited to) all aspects of the collection, processing, and reporting of individual cases safety reports (ICSRs), literature screening and review for safety, drug coding, maintenance of drug dictionary, Medical Dictionary for Regulatory Activities (MedDRA) coding, data management activities which includes cleaning and validation of data (xEVMPD product dictionary, manual recoding of substance/product terms arising from ISCR reports, management of duplicate ICSR cases, Quality review of ICSRs, Substances, Products, Organizations and Referential (SPOR) / Identification of Medicinal Products (IDMP) activities)) and the preparation of expedited and periodic safety reports, while adhering to all data privacy guidelines, Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), regulatory guidelines, company and project/program-specific procedures for clinical trials and/or post-marketing safety programs. The processing of information may include filtering, cleaning, migrating, analyzing, reporting, filing or publication of data and information.