Job Description

Updated: Yesterday
Location: India-Asia Pacific - IND-Gurugram-Cyber-City, India
Job ID: 22009435

Description

Safety & Pharmacovigilance Coordinator

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

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

• Monitors and routes incoming information to the appropriate project
• Records all ICSR documentation and tracks in accordance with Sponsor/customer specifications; distributes incoming mail and faxes.
• Redacts patient identifying information/ images in accordance with data protection guidelines, ICH GCP and GVP.
• Enters data into the safety database in accordance with Sponsor/customer specific guidelines and Company standards.
• Ensures current conventions are followed when entering cases into the Safety database.
• Performs file creation, tracking, retention, and maintenance (paper and electronic).
• Manages the translation process for any source documents requiring translation.
• Performs or assist with query follow up process as instructed
• Assists with submission processes as required
• Assists with daily workflow reconciliation
• Maintains understanding of Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, Good Pharmacovigilance Practice (GVP) modules, study/program plans and the drug development process.

Qualifications

What we're looking for

• Any M. Pharm, Pharm D, graduates (2020/21/22 pass outs) with no backlogs or awaiting results. Preferably Pharm D and M. Pharm qualified students Must have done Trainings / Certification in Pharmacovigilance
• Excellent Communication - Oral & Written
• Good proficiency in MS Office suite and have good typing skills
• Available to join immediately
• It is going to be office based opportunity, if applicant is looking for only Home based opportunities then they are not suitable for the positions
• Should have high speed internet at home to support office work without interruption
• Applicant Must be from Delhi / Gurgaon or Near by Cities . Ex: We are not going to consider applicants from Maharashtra/Hyderabad/Bangalore near by cities applicants and applying for Gurgaon location
• Safety Database systems and medical terminology preferred.
• Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace) and internet.
• Works with others as part of a team
• Ability to successfully prioritize and work on multiple tasks
• Excellent communication and interpersonal skills, both written and spoken
• Strong organizational and documentation skills
• Detailed oriented with a high degree of accuracy
• Ready to Join us Immediately

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

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 . 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.

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