Sr. Pharmacovigilance Scientist

Alkermes • Waltham, MA

6h

About The Position

The Senior PV Scientist serves as a critical medical analytic and coordinating
role in partnership with the Safety MD/Medical Monitor for assigned marketed
and/or investigational product(s).  The Senior PV Scientist is expected to be
equally effective in working collaboratively or independently. She/he must
demonstrate effective leadership skills with cross functional partners to ensure
that signaling, safety data analyses/authorship for ad hoc queries and aggregate
reports are of high quality and are completed and submitted according to
required timelines.  For investigational products, this role may also
participate in protocol design, safety CRF development, safety monitoring plan,
support of DSMB activities, coding review as well as SAE reconciliation
activities.  The Senior PV Scientist also plays a key role in ensuring that the
above activities remain compliant with evolving regulations, that respective
SOPs and work instructions regarding signaling, ad hoc and aggregate safety and
risk management reports are adequate.

The successful candidate will have demonstrated successful mastery of the above
responsibilities in their work. Accountability and a sense of urgency in
leading/managing projects is a key success factor for this role. Demonstrated
ability to assimilate clinical data, and through its analyses/review be able to
make crisp assessments and be able to communicate this effectively both verbally
and in writing plays a critical capability in this job.

Why join Team Alkermes?

Alkermes applies its decades of deep neuroscience expertise to develop medicines
designed to help people living with complex and difficult-to-treat psychiatric
and neurological disorders. A global biopharmaceutical company, headquartered in
Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a
meaningful difference in the way people manage their diseases. We have a
portfolio of proprietary commercial products for the treatment of alcohol
dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy,
and a pipeline of clinical and preclinical candidates in development for various
psychiatric and neurological disorders.

We are proud to have been recognized as an employer of choice by many national
organizations. In 2024 and 2025, we were certified as a Great Place to Work in
the U.S. and named one of Massachusetts’ Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier
and recognized as a Best Place to Work in BioPharma by Fortune Magazine. 

Alkermes, Inc. is an equal employment opportunity employer and does not
discriminate against any qualified applicant or employee because of race, creed,
color, age, national origin, ancestry, religion, gender, sexual orientation,
gender expression and identity, disability, genetic information, veteran status,
military status, application for military service or any other characteristic
protected by local, state or federal law.  Alkermes also complies with all work
authorization and employment eligibility verification requirements of the
Immigration and Nationality Act and IRCA.  Alkermes is an E-Verify employer.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed