Spvg Scientific Spec Ii

1 week ago

Hyderabad, India Syneos Health Clinical Full time

**SPVG Scientific Spec II - Literature Review**
**-**
**(**
**22007651**
**)**

**Description**

**SPVG Scientific Specialist II**

Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason - we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.

**Why Syneos Health**
- #SyneosHealthLife means we’re committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
- We believe our success is a direct result of the people who are driving it - you We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
- 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**
- Collaborates with the Client and internal project management associates for safety and pharmacovigilance activities including (but not limited to) literature screening and review, drug coding, maintenance of drug dictionary, Medical Dictionary for Regulatory Activities (MedDRA) coding, case processing or review of individual case safety reports, authoring or review of aggregate reports and ongoing safety evaluation activities. The processing of information may include filtering, cleaning, migrating, analysing, reporting, filing or publication of data and information.
- Assists in the set-up for safety and pharmacovigilance programs
- Maintains safety tracking for assigned activities
- Fosters constructive and professional working relationships with all project team members, internal and external
- Assists in the preparation of data for internal project review meetings and participates as required
- Participates in audits as required/appropriate
- Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities
- Files documents according to project specific requirements (electronically or in hard copy as applicable)
- Provides support with miscellaneous project tasks related to safety and pharmacovigilance activities
- Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Program Specific FIle or Pharmacovigilance System Master File for post-marketing programs as appropriate
- Provides support with miscellaneous project tasks related to safety and pharmacovigilance activities
- Maintains an understanding and compliance with Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, the drug development process and GVP

**Qualifications**

**What we’re looking for**

Bachelor’s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.

Should have 3-5+ years of working experience of Literature review in Case Processing related activites

Should have working experience in PubMed, Embase tools

Safety and Pharmacovigilance experience preferred

Knowledge of medical terminology preferred.

Ability to work independently and in a team environment

Ability to successfully prioritize and work on multiple tasks

Good communication and interpersonal skills, both written and spoken

Strong organizational and documentation skillsx

Able to make effective decisions

Detailed oriented with a high degree of accuracy and ability to meet deadlines

Good knowledge of ICH guidelines, GVP and regulations relating to Safety and Pharmacovigilance

**Get to know Syneos Health**
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. 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

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